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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
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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
