Ocular Therapeutix Announces Positive Phase 2 PAXTRAVA Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting - Seite 2

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.”