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]

Core Insights - Palatin Technologies, Inc. announced promising preclinical data for its melanocortin agonists PL9654 and PL9655, which show potential in treating diabetic retinopathy through inflammation resolution, vascular stabilization, and neuroprotection [1][4] Group 1: Findings on PL9654 and PL9655 - The compounds demonstrated the ability to resolve inflammation, stabilize the blood-retinal barrier, reduce VEGF signaling, and protect retinal ganglion cells, which are critical in preventing vision loss in diabetic retinopathy [2][4] - Efficacy was observed across multiple models and administration routes, including topical delivery [2][4] - The research highlights the unique capability of Palatin's melanocortin data in demonstrating multi-pathway inflammation resolution [4] Group 2: Diabetic Retinopathy Overview - Diabetic retinopathy is a progressive complication of diabetes that damages retinal blood vessels, leading to vision loss and is a leading cause of vision impairment among adults aged 20 to 64 [5] - The prevalence of diabetic retinopathy is projected to increase significantly, with estimates indicating that 11.3 million people in the U.S. will be affected by 2030, rising to 14.6 million by 2050 [8] Group 3: Melanocortin Receptor System - The melanocortin receptor system is crucial for regulating inflammation, immune response, and tissue repair, with agonists showing promise in restoring tissue homeostasis in various diseases [6] - PL9654 and PL9655 are positioned as a new class of anti-inflammatory and neuroprotective therapeutics, with the potential for earlier intervention compared to current therapies [7] Group 4: Company Strategy and Future Outlook - Palatin is focused on developing first-in-class medicines that modulate inflammatory pathways and preserve retinal structure and function [7] - The company aims to form marketing collaborations to maximize the commercial potential of its products [9]