EyePoint Pharmaceuticals Inc (EYPT)

[abrooklyn]

EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments

Source: GlobeNewswire Inc.

EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and highlighted recent corporate developments.
“2023 was an exceptional year of execution and results for EyePoint Pharmaceuticals. The highlights include positive data from our Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD, the continued advancement of our ongoing Phase 2 trials in NPDR and DME and the strengthening of our balance sheet with a $230 million oversubscribed financing in December along with the sale of rights to YUTIQ® for $82.5 million plus future royalties last May,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “The DAVIO 2 clinical trial for EYP-1901 achieved all primary and secondary endpoints, highlighting its potential to become a paradigm-altering maintenance treatment for patients with wet AMD. We look forward to discussing our Phase 3 plans with the U.S. Food and Drug Administration (FDA) at a planned end of Phase 2 meeting this April and initiating the first pivotal trial in the second half of this year.”

Dr. Duker continued, “We anticipate topline data for the Phase 2 PAVIA clinical trial of EYP-1901 in moderately severe-to-severe non-proliferative diabetic retinopathy (NPDR) in the second quarter of 2024. We are excited about the potential of EYP-1901 in NPDR, a chronic disease where over 90% of patients currently receive no course of treatment until they develop sight-threatening complications. 2024 promises to be another transformative year as we continue to advance EYP-1901 through clinical development across these three very significant indications.”

R&D Highlights and Updates

Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 clinical trial of EYP-1901 in wet AMD in December 2023. DAVIO 2 met all primary and secondary endpoints with both EYP-1901 doses demonstrating a statistically non-inferior change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs).
DAVIO 2 Phase 2 data and sub-group analyses which underscore the favorable clinical profile of EYP-1901, were presented at Angiogenesis, Exudation, and Degeneration 2024 Meeting and at the 47th Annual Meeting of the Macula Society in February 2024.
The Company plans to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in April 2024, with the initiation of the first Phase 3 pivotal trial in wet AMD expected in the second half of 2024.
Announced first patient dosed in the Phase 2 VERONA clinical trial of EYP-1901 for the treatment of diabetic macular edema (DME). Topline data are expected in the first quarter of 2025.
Accepted to present at the upcoming 2024 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. The Company will be presenting an encore presentation of the DAVIO 2 clinical trial results, the design and function of EYP-1901, plasma PK data of EYP-1901, and the mechanism of action (MOA) of vorolanib and differentiation from other anti-VEGF TKIs.
Recent Corporate Highlights

Announced the appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer in March. Dr. Ribeiro joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development.
Completed an upsized underwritten public offering with gross proceeds of $230.0 million in December. The Company sold 13,529,411 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,764,705 shares of common stock. The shares of common stock were sold at a public offering price of $17.00 per share.
Review of Results for the Fourth Quarter Ended December 31, 2023

For the quarter ended December 31, 2023, total net revenue was $14.0 million compared to $10.5 million for the quarter ended December 31, 2022. Net product revenue for the quarter ended December 31, 2023, was $0.7 million, compared to net product revenue for the quarter ended December 31, 2022, of $9.9 million. The decrease in net product revenue resulted from the strategic exit from our commercial business in 1H 2023.

Net revenue from royalties and collaborations for the quarter ended December 31, 2023, totaled $13.3 million compared to $0.7 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the license of the YUTIQ franchise, which beginning in 2Q 2023 will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.

Operating expenses for the quarter ended December 31, 2023, totaled $30.4 million compared to $54.3 million in the prior year period. This decrease was primarily driven by the strategic exit from our commercial business in 1H 2023 and a one-time intangible asset impairment charge in 4Q 2022.

Net non-operating income totaled $2.3 million and net loss was $14.1 million, or ($0.33) per share, compared to a net loss of $43.5 million, or ($1.16) per share, for the prior year period.

Review of Results for the Full Year Ended December 31, 2023

For the full year ended December 31, 2023, total net revenue was $46.0 million compared to $41.4 million for the year ended December 31, 2022. Net product revenue for the full year ended December 31, 2023, was $14.2 million, compared to net product revenues for the full year ended December 31, 2022, of $39.9 million. The decrease in net product revenue resulted from the Company’s strategic exit from its commercial business in 1H 2023.

Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled $31.8 million compared to $1.5 million in the corresponding period in 2022.

Operating expenses for the full year ended December 31, 2023, totaled $121.1 million versus $141.0 million in the prior year period. This decrease was primarily driven by the strategic exit from our commercial business in 1H 2023 and a one-time intangible asset impairment charge in 4Q 2022.

Net non-operating expense totaled $4.4 million and net loss was $70.8 million, or ($1.82) per share, compared to a net loss of $102.3 million, or ($2.74) per share, for the prior year period.

Cash, cash equivalents and investments in marketable securities on December 31, 2023, totaled $331.1 million compared to $144.6 million as of December 31, 2022.

Financial Outlook

We expect that our cash, cash equivalents, and investments on December 31, 2023, will enable us to fund operations through topline data for the planned Phase 3 clinical trials of EYP-1901 for wet AMD in 2026.

Conference Call Information

EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI91be5d0e320646e887cf4047c70fe73c. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. Pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.

EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2301; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700
[e-mail]

Media Contact:

Amy Phillips
Green Room Communications
Direct: 412-327-9499
[e-mail]

[Monksdream]

EYPT new 52 week high

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Market Cap

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Prevalence of AMD

Approximately 20 million people in the United States have AMD, and nearly 1.5 million Americans have the advanced form of the disease.2,5

About 200,000 new cases of wet AMD are diagnosed each year in North America.6

Between 2010 and 2050, the estimated number of people with AMD will more than double from 2.1 million to 5.4 million.7

[url]https://www.gene.com/patients/disease-education/amd-fact-sheet#:~:text=Wet%20AMD%20accounts%20for%20approximately,90%20percent%20of%20legal%20blindness.&text=Wet%2C%20or%20neovascular%2C%20AMD%20is,rapid%20and%20severe%20vision%20loss.
[/url][tag]About[/tag]

References

1 National Eye Institute. Age-related macular degeneration: What You Should Know. National Eye Institute:
NIH publication 03-2294. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration#section-id-7325. Accessed February 3, 2023.

2 BrightFocus Foundation. Age-Related Macular Degeneration: Facts & Figures. Available at: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. Accessed February 3, 2023.

3 Jager RD, Mieler WF, Miller JW. Age-Related macular degeneration. New England Journal of Medicine. 2008; 358:2606-2617

4 American Academy of Ophthalmology. What is Macular Degeneration?. Available at: https://www.aao.org/eye-health/diseases/amd-macular-degeneration. Accessed February 3, 2023.

5 JAMA Ophthalmology. Original Investigation: Prevalence of Age-Related Macular Degeneration in the US in 2019. Available at: https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2797921. Accessed February 3, 2023.

6 Maguire MG. Comparing treatments for age-related macular degeneration: safety, effectiveness and cost. Issue Brief. 2012;17(8). Leonard Davis Institute of Health Economics. Accessed February 7, 2020. https://ldi.upenn.edu/wp-content/uploads/archive/pdf/Issue%20Brief%2017_8.pdf

7 National Eye Institute.Age-Related Macular Degeneration: NEI Looks Ahead. States. Available at: https://medialibrary.nei.nih.gov/search?keywords=&f%5B0%5D=category%3A4#/media/1777. Accessed February 3, 2023.

8 BrightFocus Foundation. Macular Degeneration: Essential Facts. Available at: https://www.brightfocus.org/macular/news/macular-essential-facts. Accessed February 3, 2023.

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Phase 3 starts second half of 2024

“The findings from these subgroup analyses reinforce the highly favorable clinical profile of EYP-1901 and its potential to be a paradigm-altering maintenance treatment for patients with wet AMD,” said Jay Duker, M.D., Chief Executive Officer of EyePoint Pharmaceuticals. “The data demonstrated that in the subgroup analysis of patients that were supplement free up to 6 months, patients that received EYP-1901 demonstrated numerical superiority in change in best corrected visual acuity (BCVA) as well as anatomic stability compared to aflibercept. This result confirms that the positive visual and anatomical outcomes from our Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections. We look forward to discussing plans for our upcoming Phase 3 trials, which we expect to initiate in the second half of 2024, at our end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).”

The presented analyses of the data reveal:

In the sub-group of patients who were supplement-free up to 6 months, the EYP-1901 groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group. This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by study eyes requiring supplemental injection.

Visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden.

EYP-1901outcomes are consistent and durable in a range of wet AMD patient types.

A second presentation also included the previously reported positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901. The trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). The trial also achieved key secondary endpoints with both EYP-1901 doses, including an approximately 85% mean reduction in historical treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 83% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control in both EYP-1901 cohorts as measured by optical coherence tomography (OCT).

DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a standard intravitreal injection in the physician’s office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection. Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).

Phase 2 DAVIO 2 12-month results and the initiation of a Phase 3 trial in wet AMD are both expected in the second half of 2024. The Company remains on track to report additional clinical milestones with EYP-1901 this year with the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024.

About Wet AMD

Age-related macular degeneration (AMD) is a leading cause of vision loss and irreversible blindness in people over the age of 60. Wet AMD is an advanced form of the condition that develops when abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially rapid and severe vision loss.

Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function.

Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.

About EYP-1901

EYP-1901 is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and may have antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order release kinetics for approximately nine months.

https://finance.yahoo.com/news/eyepoint-pharmaceuticals-announces-two-presentations-212000392.html

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Eyepoint web site

DAVIO 2 - Phase 2

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EyePoint Pharmaceuticals Announces Two Presentations of Topline Data with Additional Subgroup Analyses from the Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Treatment of Wet Age-Related Macular Degeneration

Subgroup analyses underscore favorable clinical profile and durability of EYP-1901

Presentations highlight previously reported positive Phase 2 DAVIO 2 topline results showing all primary and secondary endpoints were met

Results presented today at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting

https://finance.yahoo.com/news/eyepoint-pharmaceuticals-announces-two-presentations-212000392.html

[MiamiGent]

Wow! A five bagger!
Nicee

[Monksdream]

EYPT new 52 week high

[Monksdream]

EYPT new 52 week high

[MiamiGent]

EYPT Looks like it was set for dilution
Prolly see a notice of pricing soon

The stars were aligned for more today otherwise, imo
I was not in the play


Filed Pursuant to Rule 424(b)(5)
Registration No. 333-275125

The information in this preliminary prospectus supplement is not complete and may be changed. The registration statement relating to these securities has been declared effective by the Securities and Exchange Commission. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities, and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to completion, dated December 4, 2023

Prospectus Supplement

(To prospectus dated October 30, 2023)

$175,000,000

EyePoint Pharmaceuticals, Inc.



LOGO

Common Stock

We are offering $175,000,000 million of shares of our common stock, par value $0.001 per share, at a public offering price of $ per share of common stock.

Our common stock is listed on The Nasdaq Global Market under the symbol “EYPT.” On December 1, 2023, the closing price of our common stock, as reported on The Nasdaq Global Market, was $6.61 per share.




Per Share Total
Public offering price

$ $
Underwriting discounts and commissions(1)

$ $
Proceeds to EyePoint Pharmaceuticals, Inc., before expenses

$ $


(1) See “Underwriting” beginning on page S-21 of this prospectus supplement for additional information regarding total underwriting compensation.
We have granted the underwriters an option for a period of 30 days to purchase up to an additional $26,250,000 of shares of our common stock at the public offering price, less the underwriting discounts and commissions.

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties referenced under the heading “Risk Factors” on page S-7 of this prospectus supplement, page 6 of the accompanying prospectus and in the documents that are incorporated herein by reference.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the shares of common stock against payment on or about December , 2023.



J.P. Morgan TD Cowen Guggenheim Securities

[MiamiGent]

EYPT Day range $17.31 - $22.44

[MiamiGent]

EYPT 52-week range $2.19 - $22.44

[MiamiGent]

EYPT hanging high.. but no more, yet
EYPT $19.93 +13.32 (+201.51%)
As of Dec-04-2023 2:48 PM

Volume
18,297,290

10/90-day avg. vol.
778K / 559K

Day range
$17.31 - $22.44

52-week range
$2.19 - $22.44

[MiamiGent]

EYPT View: A legit manic Monday play

Pros
Solid news- passed PH2 with flying colors
Co has plenty of cash so dilution not likely
Heavily 'tute & insider owned so stable stock
Float is terribly tiny- terrible for the 5.4M short shares!
Partnerships/buyouts could come along

Cons
PH 3 not til 2nd half '24
Shorts may sweat out their positions

View
This could run +425% today the way bios have been running lately, before slowly returning to earth

Players- enjoy the play
Newbees- Beware. Unless you understand the movement of these mercurial plays and are nimble as the dickens, better to watch and learn.

[makinezmoney]

$EYPT: Almost 1k Dec $10 call-options loaded on FRIDAY

Just 30mins beffore the close at $1 prem.

ANnnnnnnnnnnnnnndddddddddddddddd................. now u know whhy.

Someone always knows........................ These are gonna be 25x baggers at the open.


HAAAAAAAAAAAAAAAAAAAAAA


GO $EYPT

[subslover]

EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints
– Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint –

– Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs –

– Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to six-months –

– Strong anatomical control in both EYP-1901 cohorts documented by optical coherence tomography (OCT) –

– Conference call to discuss the results to be held today, December 4, 2023 at 8:00 a.m. ET –

WATERTOWN, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E™. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).

“We are incredibly pleased by these highly positive Phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile. Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “I would like to thank the patients and the investigators who participated in the DAVIO 2 trial as well as our employees who helped advance us to this important milestone.”

Dr. Duker continued, “the DAVIO 2 clinical trial was designed to support the initiation of Phase 3 clinical trials based on feedback received from the U.S. Food and Drug Administration (FDA) at a Type C meeting last year. The 32-week topline DAVIO 2 data strongly supports our planned Phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials. We look forward to continuing our dialogue regarding our Phase 3 plans with the FDA as we prepare to initiate our first pivotal trial for wet AMD in the second half of 2024.”

“These highly positive Phase 2 results are the result of years of hard work by the dedicated EyePoint team coupled with our proven Durasert technology which continues to demonstrate the benefit of zero order kinetics drug delivery. I look forward to initiation of Phase 3 and potentially bringing this innovative and much needed new drug to market for patients suffering from these blinding eye diseases,” said Nancy Lurker, Executive Vice Chair of EyePoint Pharmaceuticals. “I want to congratulate the EyePoint team on the continued execution of this program.”

DAVIO 2 topline interim results include:

Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints.
Statistical non-inferiority in change in BCVA (at a confidence interval of 95%) compared to aflibercept control, at weeks 28 and weeks 32 combined. The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart.
Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs.
89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses.
65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901.
Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.
Patient discontinuation up to week 32 was low at 4%.
“Wet AMD is a prevalent and progressive lifetime disease. With frequent treatment, patients can maintain their visual acuity, but the unfortunate reality is that many patients end up undertreated due to the burden of dosing of the currently available, short-acting anti-VEGF therapies,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital. “I am very encouraged by the data generated from both the Phase 1 DAVIO and Phase 2 DAVIO 2 trials with the latter showing essentially no difference in visual outcome at the blended six-month endpoint from a single injection of EYP-1901 compared to on-label, bimonthly aflibercept injections. Based on the meaningful reduction in treatment burden and supplement-free rates observed, along with the consistently favorable safety profile, I believe that EYP-1901 could be a paradigm shift in how patients with wet AMD are treated.”

DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection. Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).

EyePoint plans to present the DAVIO 2 dataset at Angiogenesis, Exudation, and Degeneration 2024 in February.

The Company remains on track to reach additional clinical milestones with EYP-1901 with the initiation of the Phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2024 and the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024.

Conference Call and Webcast Information

EyePoint will host a conference call today, December 4, 2023 at 8:00 a.m. ET to discuss the results. To access the live conference call, please register at https://register.vevent.com/register/BI4c4d93355a394ea284131d7b537fd513. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of irreversible blindness or vision loss in people over the age of 60. Wet AMD is an advanced form of the condition that develops when abnormal blood vessels grow into the macula, leaking blood or fluid that leads to scarring of the macula and potentially rapid and severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.

About EYP-1901

EYP-1901 is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor blocker, blocking all VEGF isoforms. Vorolanib features reduced off-target binding and at clinically relevant doses does not inhibit Tie-2, a critical pathway associated with vascular stability, which may result in an improved efficacy. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection, and potential antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a single intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order kinetic release for approximately nine months.

Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and OCT, and a favorable safety profile. Further, the recent DAVIO 2 data demonstrated an impressive treatment burden reduction of over 85% at six months, and over 80% of patients remained supplement-free or only received one supplemental anti-VEGF injection up to 6 months. The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program to Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024.

EYP-1901 is also being studied in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME). The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data anticipated in the second quarter of 2024. The Phase 2 VERONA trial in DME is planned to initiate in the first quarter of 2024.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. Additional pipeline programs include EYP-2301, a promising Tie-2 activator, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in wet AMD and diabetic eye disease. The proven Durasert® drug delivery platform has been safely administered to over thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.

EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2

[TaperT2]

Unreal Blast Off

[abrooklyn]

EyePoint Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Developments

Source: GlobeNewswire Inc.

EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with retinal diseases, today announced financial results for the third quarter ended September 30, 2023, and highlighted recent corporate developments.
“We continued advancing EYP-1901 through clinical development in the third quarter, announcing positive masked safety results for our lead product candidate EYP-1901 in the ongoing DAVIO 2 and PAVIA Phase 2 clinical trials,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “We remain on-track to report topline data for the DAVIO 2 trial in wet AMD in December 2023 and the PAVIA trial in non-proliferative diabetic retinopathy in the second quarter of 2024. We also plan to initiate the Phase 2 VERONA trial of EYP-1901 in diabetic macular edema in the first quarter of 2024.”

Dr. Duker continued, “It is an exciting time for EyePoint as we are well-positioned to execute on key near-term milestones and drive value for shareholders. We remain laser focused on our mission of making a difference in the lives of patients suffering from retinal diseases.”

R&D Highlights and Updates

Accepted to present at the upcoming American Academy of Ophthalmology (AAO) Annual Meeting in November, including at AAO’s Eyecelerator pre-meeting tomorrow, November 2, 2023. At Eyecelerator, the Company will be presenting interim masked safety data through October 1, 2023 from its ongoing DAVIO 2 and PAVIA Phase 2 clinical trials.
At the AAO Annual Meeting, EyePoint will be presenting an encore presentation of preclinical data highlighting the potential neuroprotective effect of vorolanib, the active drug in EYP-1901, against photoreceptor degeneration in a validated rodent retinal detachment model.
Presented subgroup analyses of the Phase 1 DAVIO trial of EYP-1901 demonstrating reduced treatment burden in wet AMD at the EURETINA Congress and the Retina Society Annual Meeting in October.
Presented a comparison of the antiangiogenic profile of tyrosine kinase inhibitors vorolanib, axitinib, and sunitinib at the Retina Society Annual Meeting in October demonstrating effective inhibition of receptors involved in pathological angiogenesis with vorolanib not having a physiological impact on TIE 2 function.
Announced EYP-2301, razuprotafib (a TIE-2 agonist) in Durasert E as a potential sustained delivery treatment for patients with serious retinal diseases.
Presented interim masked safety and baseline patient demographics of the DAVIO 2 clinical trial in wet AMD at the OIS Retina Innovation Summit in July. In addition to positive safety data, an analysis of the reported patient demographics suggests that Phase 2 DAVIO 2 patients have, on average, better starting visual acuity and less central subfield thickness than the Phase 1 DAVIO cohort.
Presented 12-month ocular pharmacokinetic results from a study evaluating EYP-1901’s drug delivery through the Durasert platform at the American Society of Retina Specialists (ASRS) Annual Meeting in July. The Company also presented an encore subgroup analysis of the EYP-1901 final twelve-month Phase 1 DAVIO results, which showed that 67% of the DAVIO patients with no excess fluid at screening did not require a supplemental anti-VEGF injection up to the six-month visit.
Plans to initiate VERONA, a Phase 2 clinical trial evaluating EYP-1901 in diabetic macular edema (DME) in the first quarter of 2024 remain on track.
Recent Corporate Highlights

Announced the promotion of George Elston to Executive Vice President and the appointment of Stuart M. Duty to the Company’s Board of Directors in October 2023.
Appointed Jay S. Duker, M.D. as President and Chief Executive Officer and member of the Board of Directors as part of a CEO transition in July 2023. Dr. Duker was previously Chief Operating Officer and President. Nancy S. Lurker transitioned to the role of Executive Vice Chair of the Board of Directors from the position of CEO.
Appointed Marcia Sellos-Moura, Ph.D. as Senior Vice President, Program Leadership on July 31, 2023. Dr. Sellos-Moura brings over 20 years of biopharmaceutical experience to the Company.
Review of Results for the Third Quarter Ended September 30, 2023

For the third quarter ended September 30, 2023, total net revenue was $15.2 million compared to $10.0 million for the quarter ended September 30, 2022. Net product revenue for the third quarter was $0.8 million, compared to net product revenues for the third quarter ended September 30, 2022 of $9.7 million. The decrease in net product revenue resulted from sale of the YUTIQ franchise in May 2023 and the discontinuation of DEXYCU commercialization activities in 2023.

Net revenue from royalties and collaborations for the third quarter ended September 30, 2023 totaled $14.4 million compared to $0.3 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the sale of the YUTIQ franchise which will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.

Operating expenses for the third quarter ended September 30, 2023 totaled $29.6 million versus $28.4 million in the prior year period. This increase was primarily driven by R&D spending on the ongoing EYP-1901 clinical trials, partially offset by reduced sales and marketing expense. Non-operating expense, net, totaled $1.8 million and net loss was $12.6 million, or ($0.33) per share, compared to a net loss of $18.4 million, or ($.49) per share, for the prior year period.

Cash and investments at September 30, 2023 totaled $136.0 million compared to $144.6 million at December 31, 2022.

Financial Outlook

We expect the cash, cash equivalents and investments on September 30, 2023 will enable us to fund our current and planned operations into 2025.

Conference Call Information

EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the third quarter ended September 30, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI3b701846a11841ad855aab9d0b8aff10. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary erodible Durasert E™ technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert® drug delivery platform has been safely administered to over 80,000 patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.

EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the sufficiency of our existing cash resources into 2025; our plans and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements containing the words “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration, non-proliferative diabetic retinopathy and diabetic macular edema; our ability to realize the anticipated benefits of the 2023 sale of YUTIQ® to Alimera Sciences including our potential to receive additional payments from Alimera pursuant to the our agreements with Alimera; our ability to manufacture YUTIQ in sufficient quantities pursuant to our commercial supply agreements with Alimera and Ocumension Therapeutics; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements, including our agreements with Alimera, Ocumension, Equinox Science and Betta Pharmaceuticals; termination or breach of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition; market acceptance of our products, including our out-licensed products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; the extent to which COVID-19 impacts our business and the medical community; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; the sufficiency of the Company’s cash resources and need for additional financing; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated, or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated, or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700
[e-mail]

Media Contact:

Amy Phillips
Green Room Communications
Direct: 412-327-9499
[e-mail]




EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)

September 30, December 31,
2023 2022
Assets
Current assets:
Cash and cash equivalents $ 133,035 $ 95,633
Marketable securities 2,977 48,928
Accounts and other receivables, net 483 15,503
Prepaid expenses and other current assets 9,091 9,858
Inventory 4,577 2,886
Total current assets 150,163 172,808
Operating lease right-of-use assets 5,250 6,038
Other assets 4,630 1,510
Total assets $ 160,043 $ 180,356
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $ 22,997 $ 22,278
Deferred revenue 39,841 1,205
Short-term borrowings - 10,475
Other current liabilities 1,058 579
Total current liabilities 63,896 34,537
Long-term debt - 29,310
Deferred revenue - noncurrent 32,341 13,557
Operating lease liabilities - noncurrent 5,185 5,984
Other long-term liabilities - 600
Total liabilities 101,422 83,988

Stockholders' equity:
Capital 785,827 766,933
Accumulated deficit (728,047 ) (671,351 )
Accumulated other comprehensive income 841 786
Total stockholders' equity 58,621 96,368
Total liabilities and stockholders' equity $ 160,043 $ 180,356



EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)

Three Months Ended
September 30, Nine Months Ended
September 30,
2023 2022 2023 2022
Revenues:
Product sales, net $ 816 $ 9,720 $ 13,483 $ 30,048
License and collaboration agreements 14,137 52 17,768 160
Royalty income 249 240 739 663
Total revenues 15,202 10,012 31,990 30,871
Operating expenses:
Cost of sales, excluding amortization of acquired intangible assets 1,202 1,405 3,634 4,916
Research and development 17,363 11,162 46,711 34,099
Sales and marketing 479 6,016 11,504 19,592
General and administrative 10,556 9,212 28,854 26,321
Amortization of acquired intangible assets - 615 - 1,845
Total operating expenses 29,600 28,410 90,703 86,773
Loss from operations (14,398 ) (18,398 ) (58,713 ) (55,902 )
Other income (expense):
Interest and other income, net 1,786 640 4,611 1,067
Interest expense - (662 ) (1,247 ) (2,408 )
Loss on extinguishment of debt - - (1,347 ) (1,559 )
Total other expense, net 1,786 (22 ) 2,017 (2,900 )
Net loss $ (12,612 ) $ (18,420 ) $ (56,696 ) $ (58,802 )
Net loss per common share - basic and diluted $ (0.33 ) $ (0.49 ) $ (1.50 ) $ (1.58 )
Weighted average common shares outstanding - basic and diluted 38,341 37,338 37,804 37,305


Primary Logo

[Monksdream]

EYPT new 52 week high

[glenn1919]

EYPT......................https://stockcharts.com/h-sc/ui?s=EYPT&p=W&b=5&g=0&id=p86431144783

[glenn1919]

EYPT..................https://stockcharts.com/h-sc/ui?s=EYPT&p=W&b=5&g=0&id=p86431144783T

[glenn1919]

EYPT.......................https://stockcharts.com/h-sc/ui?s=EYPT&p=W&b=5&g=0&id=p86431144783

[glenn1919]

EYPT.................................https://stockcharts.com/h-sc/ui?s=EYPT&p=W&b=5&g=0&id=p86431144783

[conix]

Keeping an eye on ocular diseases... This metformin treatment is promising.

https://www.healio.com/news/ophthalmology/20220716/lowerdose-metformin-may-be-linked-with-reduced-amd-risk

[Pennybuster]

Thanks Conix. :)

[conix]

EyePoint Pharma announces positive 12-month safety and efficacy data from phase 1 DAVIO trial of EYP-1901 to treat wet AMD

Watertown, Massachusetts

Monday, July 18, 2022, 14:00 Hrs [IST]

EyePoint Pharmaceuticals, Inc announced 12-month data from the phase 1 "Durasert and Vorolanib in Ophthalmology" (DAVIO) clinical trial evaluating EYP-1901, a sustained delivery anti-vascular endothelial growth factor (anti-VEGF) therapy targeting wet age-related macular degeneration (wet AMD) as a potential every six-month treatment. These data are being presented at the American Society of Retina Specialists (ASRS) 2022 Annual Meeting by Rishi Singh, M.D., Staff physician, Cleveland Clinic Florida, president – Cleveland Clinic Martin Hospitals.

"The final 12-month results from the DAVIO clinical trial highlight EYP-1901's continued positive safety and efficacy profile with promising durability as a potential every six-month maintenance therapy for previously treated wet AMD," said Rishi Singh, M.D., a member of EyePoint's Scientific Advisory Board. "We are grateful to the patients, investigators and site staff who participated in the phase 1 DAVIO trial."

"We are extremely pleased with the excellent safety and efficacy results from our phase 1 DAVIO trial. There remains a significant opportunity for a safe and effective sustained delivery maintenance treatment in wet AMD, and the DAVIO trial demonstrates that EYP-1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy," said Nancy Lurker, chief executive officer of EyePoint Pharmaceuticals. "We look forward to beginning to dose patients in the Phase 2 DAVIO2 clinical trial for EYP-1901 in wet AMD and anticipate top line data in the second half of 2023."

The final twelve-month data presented from the phase 1 DAVIO clinical trial showed no reports of ocular SAEs or drug-related systemic SAEs. There were no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events. Additionally, updated data from the twelve-month follow-up confirm stable best corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (-2.76 µm), and an expected late increase in supplemental anti-VEGF therapy given the insert's expected drug depletion, with 35% of eyes supplement free up to twelve months versus 53% supplement free up to six months. Additionally, there continued to be positive treatment burden reduction of 74% at twelve months versus 79% at six-months.

EyePoint anticipates that the first patient in the twelve-month, randomized, controlled phase 2 clinical trial (DAVIO2) of EYP-1901 for wet AMD will be dosed in Q3 2022. The trial is expected to enroll approximately 150 wet AMD patients previously treated with a standard-of-care anti-VEGF therapy and randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) versus an on-label aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO2 trial is non-inferiority to the aflibercept control, as measured by change in BCVA six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).

EYP-1901 is being developed as an investigational sustained delivery treatment, initially in wet age-related macular degeneration (wet AMD) combining a bioerodible formulation of EyePoint's proprietary Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the phase 1 DAVIO clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% of eyes did not require supplemental anti-VEGF injections up to six months following a single dose of EYP-1901. A phase 2 trial for wet AMD (DAVIO2) is expected in Q3 2022 and phase 2 studies are planned for non-proliferative diabetic retinopathy and diabetic macular edema in 2H 2022 and 2023, respectively. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.

Age-related macular degeneration (AMD) impacts as many as 11 million Americans. About 15% of those affected have neovascular or wet AMD - the hallmark of which is fluid and bleeding in the center of the retina, which may lead to irreversible vision loss. The majority of patients with wet AMD require intravitreal injections every month or two to control the disease. This intense treatment regimen represents an ongoing challenge for patients, caregivers, and physicians.

EyePoint Pharmaceuticals is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders.

[conix]

EYPT Chart

[Pennybuster]

Adding

[Eaglepointone]

I always see Eyepoint sideways,if it stumbles and falls at 4 dollars without a doubt that I bet on Eye. Hospitals are still delaying many ophthalmology medical appointment due to Covid.

[Annjilla]

How do you like Eyepoint now?

[Annjilla]

Anyone out there with any thoughts?!

[420man]

:)

[Timing101]

$EYPT... over 9,000 Trades... 10x the average volume ... over $5,000,000 in traded volume
--
Watch this .. Great Mgt Team , Stellar proprietary Products , FDA approved and major news maker
--
https://eyepointpharma.com/news/
--
company overall .. NASDAQ
--
https://www.otcmarkets.com/filing/html?id=14391411&guid=EDa6UKDt7oFlc3h#EYPT-EX991_7_HTM

[Annjilla]

Someone else’s comment and I 100% agree with him!!!!

We should see the stock price improving up to the November 4 conference call (volume is improving) and hopefully beyond. Given that net sales revenue will likely be a positive (not a negative), the market reaction should be to push the price to a more respectable level. Yes we are currently seeing the price recovering from the recent lows.

[Annjilla]

Eypt is a BUY!!!!

[Nfixus]

New article out. Buy or sell?

https://pennystocks.news/eyepoint-pharmaceuticals-is-this-a-share-to-keep-your-eye-on-eypt/

[420man]

Out...made too much $ to risk the fallout..GL

[ClayTrader]

* * $EYPT Video Chart 08-21-2020 * *

Link to Video - click here to watch the technical chart video

[just_waiting]

we only have 35ish minute to reach .78 think we can do it.

[Surfacetite]

Took a position.

[420man]

Reload

[420man]

Runner!!!

[Annjilla]

Up huge after hours!!

[Annjilla]

Great news!

[crudeoil24]

EyePoint Pharmaceuticals shares are trading higher after the company announced it has received an upfront payment of $9.5 million after expanding its exclusive license agreements with Ocumension Therapeutics for the development and commercialization of YUTIQ and DEXYCU.

[Cecil Bob]

Money news out. Just a matter of time before eyes start catching this.

http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20200804:nGNX2T72NT

We are thrilled to add the first and only FDA-approved intracameral injectable steroid product to our portfolio of surgical formulations, which will help us address unmet medical needs in the ocular surgery market,” said John Saharek, President of ImprimisRx. “Based on the conversations we’ve have had with our customers, there is strong demand and preference for FDA-approved products, which gives me confidence that our customers will embrace the option of using DEXYCU. DEXYCU will be marketed as a top priority program within our commercial organization and our initial focus will be on accounts currently purchasing Tri-Moxi®. Having sold over 250,000 ophthalmic injectable units used during cataract surgery in 2019 to our loyal customer base, the choice to use DEXYCU, an innovative FDA-approved injectable steroid product with a specific and permanent reimbursement J-code, will give hundreds of our surgical customers a new tool to improve the health outcomes of their patients. We look forward to working in collaboration with the EyePoint team to greatly enhance the level of commercial success of DEXYCU and build customer demand in this attractive and growing market.”

[CRAZYJC]

Could be a good week

[CRAZYJC]

Added more today.....

[Farmmarket1]

Added back .83s 2 times. Long here. $EYPT