Core Insights - Ocular Therapeutix has received FDA agreement on the registrational trial design for AXPAXLI targeting non-proliferative diabetic retinopathy (NPDR) [1][2] - The company plans to present its clinical trial design and development strategy for NPDR and diabetic macular edema (DME) at an Investor Day on September 30, 2025 [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product AXPAXLI, a bioresorbable intravitreal hydrogel incorporating axitinib [3][8] - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and is being evaluated for diabetic retinopathy and DME [8] Market Opportunity - Diabetic retinopathy affects nearly 9 million people in the U.S., with a significant portion of patients not receiving treatment despite the availability of effective therapies [2][6] - The potential for AXPAXLI to provide annual dosing could transform treatment approaches, shifting from reactive to proactive disease management [2][6] Clinical Trial Insights - In the Phase 1 HELIOS trial, AXPAXLI demonstrated no disease progression or vision-threatening complications in NPDR patients at 48 weeks, compared to 25% worsening in the control group [2][6] - The treatment showed improvement in all patients with non-center involved DME, indicating its potential to reshape proactive care in diabetic eye disease [2][6] Public Health Impact - With 6.4 million Americans living with NPDR and fewer than 1% currently treated, AXPAXLI's long-acting treatment could significantly reduce vision-threatening complications from diabetes [2][6][7]