Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Laurent. Gr8 find
thx
Kiwi
OCUL. more info
Ocular Therapeutix™ Announces Positive Phase 2 PAXTRAVA™ Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting
GLOBENEWSWIRE - 10:00 AM ET 4/6/2024
INVESTMENT NEWS
Email Facebook. Twitter. LinkedIn. Print
Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single PAXTRAVA implant
Generally well tolerated with no impact on corneal health observed
Consistent durability of IOP reduction and implant bioresorption shows potential for repeat dosing without stacking of implants
Expanded Focus on Retinal Disease Highlighted at the April 4th Eyecelerator
BEDFORD, Mass., April 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. ( OCUL ) , a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced positive Phase 2 data for PAXTRAVA (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension (reported together as “glaucoma”, below) The data are being presented by Mark Gallardo, MD during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
“Ocular is very pleased to report positive six-month topline results for PAXTRAVA in the Phase 2 glaucoma study. We designed the Phase 2 clinical trial to evaluate PAXTRAVA over several time points that we believe are clinically meaningful, through six months. Observation of IOP reduction as early as the first follow-up visit, at 2 weeks, and demonstration of a 24-30% reduction in mean IOP through six months, with consistent and sustained reductions at each and every timepoint, are at the core of our enthusiasm for these results. That the majority of eyes (81.3%) treated with PAXTRAVA did not require additional IOP lowering therapy through six months further supports the strength of the data,” said Rabia Gurses Ozden, MD, Chief Medical Officer at Ocular Therapeutix ( OCUL ). “As we incorporate these efficacy data, coupled with the expanded safety database, into our evaluation of next steps for the program, we thank all of the patients, caregivers and study sites who participated in this Phase 2 study.”
Summary of Data and Findings:
Efficacy: PAXTRAVA 26 µg single implant demonstrated consistent IOP control through 6 months:
Statistically significant IOP changes from baseline were observed for each and every individual and mean diurnal measurement at Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), as well as Months 4.5 and 6 (p<0.0001), although no formal statistical testing was prespecified
Clinically meaningful mean IOP reduction of ~24-30% from baseline observed over six months
A majority (81.3%) of treated eyes did not require additional IOP-lowering therapy through 6 months indicating sustained and consistent treatment effects
Safety: PAXTRAVA 26 µg was generally well-tolerated
No impact on corneal endothelium was observed at 6 months following a single administration
Majority of adverse events (AEs) were mild in severity and generally resolved with topical medical treatment. Most ocular AEs within 3 days were deemed related to the injection procedure by the investigators. Post injection AEs observed (>3 days post injection procedure) were consistent with the travoprost label. One implant required removal (classified as a serious adverse event), most likely due to a peri-implantation bacterial infection, per investigator
Consistent bioresorption of the implant coupled with the durable effect seen in the trial suggests redosing would be possible, without the risk of stacking implants
“I have dedicated my career to taking care of people with glaucoma and the evaluation of new therapies. I am enthusiastic about PAXTRAVA because of the positive, durable IOP reductions, accompanied by a good overall safety profile,” said Mark Gallardo, MD. Dr. Gallardo is a Study Investigator and Glaucoma Specialist at El Paso Eye Surgeons. He is an active principal investigator of innovative new treatments, having participated in more than 20 clinical trials over the last 7 years.
“We were pleased to observe that PAXTRAVA generally stays in place at the site of implantation and maintains its form, that the majority of implants (64.5%) were significantly or fully bioresorbed at six months and that the implants were not observed to impact the surrounding corneal endothelium. Together, these features could address the compliance challenge of daily eyedrops and enable repeat dosing, without the risk of stacking, critical for the treatment of chronic disease. The totality of these features makes me optimistic about this product candidate.”
The complete presentation (Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: Results from a Phase 2 Clinical Trial) will be available in the Scientific and Medical presentations section of the Company’s investor website.
Phase 2 Study Overview: The PAXTRAVA Phase 2 study was designed as a randomized, parallel-group, controlled study to evaluate the safety and efficacy of PAXTRAVA in subjects with open-angle glaucoma (“OAG”) or ocular hypertension (“OHT”) and reported together as “glaucoma”, per above. Following a standard medication wash-out, patients were randomized 1:1:1 into one of three dosing groups (5 µg or 26 µg of PAXTRAVA or DURYSTA® (bimatoprost implant)), dosed in ‘the study eye’ and followed for frequent assessments through the six month analysis point. Due to elevations in IOP observed in seven out of the 16 subjects enrolled in the PAXTRAVA 5 µg arm of the trial, the Company closed enrollment in this arm and continued with the PAXTRAVA 26 µg and DURYSTA arms of the trial. Safety and efficacy data presented at ASCRS and reported in this press release are based on the 26 µg dosing group, as a result.
The enrolled subjects had a mean age of 65 years and had been previously treated with a mean of about 1.2 IOP-lowering agents prior to study entry. The treatment groups were well balanced for key demographics and baseline characteristics. The primary efficacy endpoints included measurement of changes in intraocular pressure (IOP) at three diurnal measurements (8 AM, 10AM and 4 PM) at weeks 2, 6, 12 and secondary endpoints included measurements at all other visits including 4.5 and 6 months. No formal statistical testing was prespecified in the clinical trial protocol or the statistical analysis plan. Other assessments included an evaluation of the need for additional IOP-lowering therapy, changes in endothelial count and central corneal thickness, as well as an evaluation of safety for the period.
Summary of next steps: Seek an end-of-Phase 2 meeting with the FDA to finalize development plans for PAXTRAVA Phase 3 trials and move to a next generation, commercial injector that eases initiation of therapy.
Strategic Focus on Retinal Disease Highlighted at the April 4th Eyecelerator@ASCRS Conference
On Thursday, April 4th, Pravin Dugel, MD, Executive Chairman of Ocular Therapeutix ( OCUL ) presented at the Eyecelerator@ASCRS conference. “Ocular was very pleased to connect with the Eyecelerator community to share more about our strategic vision for Ocular as we transition to a retina-focused company”, said Dr. Dugel. “There are three important pillars related to our Phase 3 program for AXPAXLI™ for wet Age-related Macular Degeneration (wet AMD) that support our transformation to a leading retina company: promising clinical data, de-risking regulatory pathway, and an expansive market opportunity. With our expanded strategic and clinical team of recognized experts in place to strengthen the Company’s retinal expertise, I believe we are on a solid path to enrich and accelerate the AXPAXLI clinical program.”
The complete presentation (Ocular Therapeutix ( OCUL ), Evolving into a leading retina company) will be available in the Events and Presentations section of the Company’s investor website.
Kiwi
OCUL. P2 data 4/5/24
REUTERS
10:03 AM ET 04/06/2024
April 6 (Reuters) - Ocular Therapeutix Inc (OCUL):
* OCULAR THERAPEUTIX™ ANNOUNCES POSITIVE PHASE 2 PAXTRAVA™ GLAUCOMA DATA AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 2024 ANNUAL MEETING
* OCULAR THERAPEUTIX INC (OCUL) - GENERALLY WELL TOLERATED WITH NO IMPACT ON CORNEAL HEALTH OBSERVED
* OCULAR THERAPEUTIX INC (OCUL) - CLINICALLY MEANINGFUL MEAN IOP REDUCTION OF ABOUT 24-30% FROM BASELINE OBSERVED OVER SIX MONTHS Source text for Eikon: Further company coverage:
Kiwi
OCUL. REUTERS
10:03 AM ET 04/06/2024
April 6 (Reuters) - Ocular Therapeutix Inc (OCUL):
* OCULAR THERAPEUTIX™ ANNOUNCES POSITIVE PHASE 2 PAXTRAVA™ GLAUCOMA DATA AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 2024 ANNUAL MEETING
* OCULAR THERAPEUTIX INC (OCUL) - GENERALLY WELL TOLERATED WITH NO IMPACT ON CORNEAL HEALTH OBSERVED
* OCULAR THERAPEUTIX INC (OCUL) - CLINICALLY MEANINGFUL MEAN IOP REDUCTION OF ABOUT 24-30% FROM BASELINE OBSERVED OVER SIX MONTHS Source text for Eikon: Further company coverage:
Kiwi
Capt ...from the Science Direct link ...Vascepa with prior MI patients ( about 3600 in R-IT )
And that's a wrap. Congrats to all who held at least some thru to the buy out ...or at least made $ on the way .
Kiwi
Table saws ..oiy .....best to avoid . 2 friends have lost part of a finger each , using table saws
UNCY, TLPH and VERA are my current CKD / dialysis positions .
I just sold my SWAV ...the core position I'd kept since $40
Re UNCY. since this trial is open label , if stock goes south badly before results I'll probably bail ...at least most of position
Good luck
Kiwi
Thx Dew I've held a core position from around $40 to today's $325 ...bumpy ride at times.
Another win for SF / Bay Area biotech :--)
Kiwi
Marjac. re
Ex Agree. The buyback is a dumb idea. Co needs to spend the $ on increasing the level of evidence ( currently 2 b ) to get wider reimbursement in the EU .
With the patent extension they now have time to do that .
Hope they do
Kiwi
Their pivotal trial is fully enrolled and over half have probably completed the trial by now .
This trial is Open Labeled ...they know who is on the drug ..so can see how they are doing
RMB. sorry been doing some minor retrofitting in the house ...remind me to never do that again ..always costs more and takes longer then I planned for ..---)
Re TLPH .....This Co is very unlikely to sell this product . They will sell to a large Pharma in the Renal space.
This is a specialty drug / treatment simply trying to get FDA approval on a drug used for decades in Japan and Korea .
It's a niche drug that ICU MD's needing to dialyze patients ...especially those with trauma or bleeding risk.
Keep an eye on UNCY
Their pivotal trial is fully enrolled . Most have probably already completed .
Its Open Label ...so they know how the patients are doing re tolerability
I agree. With the 8 yr extension of patent protection in the EU it's worth a spec buy at these levels.
Now the Co has extra time to independently confirm ( raise the level of evidence rating ) at least for some of the R-IT results and get wider reimbursement in the EU
JMO
Kiwi
AMRN
ANNX. P3 data in Q2 ...anyone following this Co ?
Kiwi
Its random risk off in a down market . This Co will live or die on a successful trial before their money runs out.
JMO
Kiwi
Well my ploy was to get you to verify it .
So obviously I've failed in that endeavor :--)
Kiwi
Hi RMB. Well it's a ..".only risk what you can afford to lose " type situation .
OLC is the strongest phosphorous lowering drug for dialysis patients with the important convenience of being one small pill swallowed with meals.
The challenge will be tolerability .
How many report stomach upsets etc and if they are bad enough to stop taking OLC.
The Co has learnt from earlier trials and will start with a low dose , gradually increasing dose just enough to lower serum phosphorus to the desired zone .
The funds Nantahala and Vivo have some serious $ at risk here so I'm assuming they have done very extensive DD .
Something else for you to consider ...TLPH ...starting a short pivotal trial .
Chk with me on that board if interested .
Nantahala is a major investor with a seat on the BOD
Kiwi
How do you know if Chat GPT didn't summarize the key pts accurately ...unless you actually looked up the FDA doc. ?
You can't .
The value of this board , to me at least , is that generally posters will back up their pts of view with links supporting their opinion.
Kiwi
So how about getting the correct answer ...copy and pasting it for us so we can see how accurate ChatGPT was ...and the time it took you to find the answer.
I'm not saying ChatGPT is perfect ...its obviously a work in process ...and I'm biased as NVDA has been my 1/3rd largest position for the past 10 mths
Kiwi
Well the question was ...Market exclusivity following approval .
Where is that mentioned in your links ( copy and paste section ...thx ) and how much time did you spend finding it ?
Kiwi
Some more :---)
ChatGPT's answer
Yes ...Breakthrough designation if approved grants market exclusivity for ??? years ?
Kiwi
Dew. a more specific answer to your questions re TLPH
TLPH. Hi Dew ...understand that this is a layman's read . My wife who rounds dialysis clinics is loath to discuss her work / patients unless she initiates the conversation / vent.
The issue is primarily in the ICU dialysis setting . Heparin and Citrate have relatively long half lives and recirculate from the dialysis lines back into the patient . These patients in the ICU often have bleeding issues and may be intolerant to Heparin and Citrate.
Nafamostat has a very short half life so far less of it gets recirculated back into the patient. .
In non ICU dialysis its use may be for those intolerant to heparin and citrate .
My quick layman take
Believe its FDA designated as Breakthough and they agreed to device track for approval based on extensive history in Korea and Japan
Kiwi
Steve I just wanted to forward this on to you if another angiogram or procedure is being considered .
Don't know what your eGFR ( kidney function ) is but this is the latest on reducing kidney injury from the contrast typically used in angiograms .
Maybe forward to your interventionist if appropriate
https://www.practiceupdate.com/c/163795/1/2/?elsca1=emc_enews_expert-insight&elsca2=email&elsca3=practiceupdate_cardio&elsca4=cardiology&elsca5=newsletter&rid=NDE0ODg4MzcyNTk0S0&lid=20845029
Good luck
Kiwi
TLPH. Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
RZLT. DME P2 results in Q2
https://www.rezolutebio.com/for-patients/living-with-dme/
Kiwi
Ps. I've been selling some on the way up so I don't do a face plant on this if P2 fails
DME P2 results due Q2
https://www.rezolutebio.com/for-patients/living-with-dme/
Kiwi
Hi Steve. I'm spending more time on RZLT now ( been in it for awhile )
So come over to that board if you're interested..
I've had a core position in SWAV since soon after its IPO ...trading around it .
I'll keep that position until buyout ..or if no buyout ...just to follow the Co .
Kiwi
Hi Steve , I think IVUS imaging is now considered better then an angiogram but only used so far in about 20% of cases due to reimbursement issues.
IVUS is better at detecting calcification inside arterial walls that may be constricting blood flow and thus enables better use of IVL technology .
I suggest you ask your interventionist / Cardiologist his views on IVUS for imaging and IVL for below the knee applications.
If he doesn't use any of these procedures maybe he could recommend some who does for a second opinion.
Most of the major teaching hospitals ( like UCSF out here ) will be using IVUS for imaging and when appropriate IVL to increase blood flow or to prepare the artery for a drug eluting stent.
Not medical advice ...just my opinion
Best of luck
Kiwi
O Not sure what you are arguing .
Your original link is pretty clear
O. LDL is a risk factor like smoking . We all know someone in their 80's who smoked a pack a day ....but population wide analysis shows lower life expectancy from smoking . Same with LDL levels. Population wide ...those with high LDL ...like over 200 mg/dl have more heart attacks strokes then those with LDL under 100 mg/dl
But its not the only risk factor
Its what you eat that matters , as well as how much exercise you get , genes , etc etc
Kiwi
Yep we need something like MITIGATE or BRAVE showing stellar results to rock everyone.
Many expected R-IT to fail back in 2018 . I think we had a contest at the time and I was on the low end of risk reduction ....had sold my position and was holding an option straddle / strangle ?that limited my downside but put me back in the stock once it crossed $6.
JL, Raf , Zip, North et al. were stead fast . R-IT would succeed ...and far better than most expected.
Kiwi
Tuesday, Shockwave Medical Inc ( SWAV ) shares traded higher following a Wall Street Journal report suggesting Johnson & Johnson ( JNJ ) is reportedly in talks to acquire the company.
Shockwave Medical ( SWAV ) is a cardiovascular medical device.
In 2022, Johnson & Johnson ( JNJ ) acquired heart failure device-focused Abiomed Inc. for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion.
Piper Sandler says it has considered Johnson & Johnson ( JNJ ) a potential buyer due to its interest in expanding into cardiovascular devices and strong financial position.
Additionally, there were reports in May 2023 indicating Johnson & Johnson’s interest in acquiring Shockwave Medical ( SWAV ). However, the Piper analyst writes that Shockwave Medical ( SWAV ) could thrive independently, maintaining the Overweight rating.
Piper’s analysis suggests that acquiring Shockwave Medical ( SWAV ) would likely require a substantial offer due to its profile.
Compared with Johnson & Johnson’s acquisition of Abiomed, which was about 12.5x consensus 2024 revenue without milestones and closer to 13.7x with milestones, it provides a benchmark.
Shockwave Medical ( SWAV ) reportedly sought bids around the mid-$300s per share, Piper notes, citing a StreetInsider report.
While a Johnson & Johnson-Shockwave Medical combination seems suitable, other major players like Medtronic Plc ( MDT ) and Boston Scientific Corporation ( BSX ) , with their focus in interventional cardiology and peripheral vascular, could also be interested.
Both Medtronic ( MDT ) and Boston Scientific ( BSX ) had shown previous interest in acquiring Shockwave Medical ( SWAV ).
The absence of obvious FTC issues suggests regulatory clearance wouldn’t be a major hurdle. A competitive bidding process could emerge, with Johnson & Johnson ( JNJ ) viewed as a strong strategic fit for Shockwave Medical ( SWAV ).
Price Action: SWAV shares closed higher by 2.07% at $322.61 on Wednesday.