Ocular Therapeutix announced Phase 2 data for PAXTRAVA in patients with open-angle glaucoma or ocular hypertension. The data was presented during the 2024 American Society of Cataract and Refractive Surgery Annual Meeting. PAXTRAVA 26 microgram 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, Week 6, and Week 12, as well as Months 4.5 and 6, although no formal statistical testing was prespecified; Clinically meaningful mean IOP reduction of about 24%-30% from baseline observed over six months; A majority of treated eyes did not require additional IOP-lowering therapy through 6 months indicating sustained and consistent treatment effects. PAXTRAVA 26 microgram was generally well-tolerated. One implant required removal, 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. The company expects to 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.
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