Ocular Therapeutix™ Announces First Patients Enrolled in Phase 3 SOL-R Wet AMD Study

Core Insights - Ocular Therapeutix is conducting a Phase 3 clinical trial named SOL-R to evaluate the safety and efficacy of AXPAXLI for treating wet age-related macular degeneration (wet AMD) [1][5] - The trial aims to compare AXPAXLI, administered every six months, to the current standard treatment of aflibercept, which is given every eight weeks [2][6] - The study will enroll approximately 825 patients, focusing on those who are treatment naïve or diagnosed with wet AMD within three months prior to enrollment [5][6] Group 1: Study Design and Objectives - SOL-R is a global, non-inferiority study designed to assess AXPAXLI against aflibercept, with a third arm for additional masking using a higher dose of aflibercept [2][5] - The primary endpoint is to demonstrate non-inferiority in mean best corrected visual acuity (BCVA) change from baseline between AXPAXLI and aflibercept at one year [6] - The trial incorporates a patient enrichment strategy, including multiple loading doses of aflibercept and monitoring to exclude patients with significant retinal fluid fluctuations [5][6] Group 2: Clinical Significance - The results from the SOL-R study are expected to provide valuable insights for the retina community regarding the potential of AXPAXLI in clinical practice [3] - The study is designed to align with real-world treatment experiences, potentially improving patient outcomes by allowing for a more convenient dosing schedule [3][5] - There is a significant need for durable treatments in wet AMD, as current therapies often lead to patient discontinuation and inadequate vision improvement [7] Group 3: Company Overview - Ocular Therapeutix is focused on developing innovative therapies for retinal diseases, with AXPAXLI being its lead product candidate [8] - The company utilizes its proprietary ELUTYX technology for AXPAXLI, which is a bioresorbable hydrogel implant incorporating axitinib, a multi-target tyrosine kinase inhibitor [4][8] - Ocular's pipeline also includes DEXTENZA, an FDA-approved product for ocular inflammation, and PAXTRAVA, which is in Phase 2 trials for glaucoma [9]