OCUL - Ocular Therapeutix™ Announces Positive Phase 2 PAXTRAVA™ Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting | Benzinga
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
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BEDFORD, Mass., April 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular", the "Company")), 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. "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 ...