Opthea Announces Phase 2b Wet AMD Publication

Core Insights - Opthea Limited announced the publication of Phase 2b data for sozinibercept in treating wet age-related macular degeneration (wet AMD) in the journal Ophthalmic Surgery, Lasers and Imaging Retina [1][2] Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing therapies for retinal diseases, particularly wet AMD and diabetic macular edema [8][9] - The lead product candidate, sozinibercept, is a first-in-class VEGF-C/D 'trap' inhibitor being evaluated in combination with standard anti-VEGF-A therapies [9] Clinical Trial Results - The Phase 2b study showed that sozinibercept combination therapy led to superior visual gains compared to ranibizumab monotherapy at 24 weeks [2][6] - In patients with occult and minimally classic lesions (73% of the total population), sozinibercept demonstrated a statistically significant additional 5.7 letter mean gain in best corrected visual acuity (BCVA) compared to ranibizumab alone [3][6] - The combination therapy also resulted in a greater proportion of patients gaining ≥15 letters and improved anatomical outcomes, including reduced choroidal neovascularization (CNV) area [3][6] Future Clinical Development - Opthea's pivotal Phase 3 program includes two trials, COAST and ShORe, designed to assess the safety and efficacy of sozinibercept combination therapy versus standard anti-VEGF-A treatments [5] - The company anticipates topline data readouts for COAST in early Q2 CY 2025 and for ShORe in mid-CY 2025 [4] Market Context - Wet AMD is a leading cause of vision loss in the elderly, affecting approximately 3.5 million people in the US and Europe [4] - There is a significant unmet medical need in wet AMD, as many patients do not achieve optimal vision outcomes with existing anti-VEGF-A therapies [4]