Ocular Therapeutix™ Highlights Exceptional AXPAXLI™ SOL-1 Enrollment and Plans for Repeat Dosing Study (SOL-R) in wet AMD at Investor Day, Along with Positive 48-week Data from HELIOS NPDR Study

Core Insights - Ocular Therapeutix is making significant progress in the clinical development of AXPAXLI for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) [1][2][3] - The company has announced plans for the SOL-R study to evaluate repeat doses of AXPAXLI in wet AMD, following positive results from the HELIOS NPDR study [1][4][5] Clinical Development Progress - As of June 7, 2024, 151 subjects have been enrolled in the pivotal SOL-1 study for AXPAXLI, with 60 active study sites [3][9] - The SOL-1 study aims to randomize 300 treatment-naïve patients, comparing AXPAXLI to aflibercept after initial loading doses of aflibercept [3][10] - The HELIOS NPDR study reported that 23.1% of patients in the AXPAXLI arm experienced a ≥2-step improvement in the diabetic retinopathy severity scale (DRSS) at 48 weeks, with no patients experiencing worsening [5][6] Future Studies and Strategy - The SOL-R study will evaluate AXPAXLI at six-month intervals compared to aflibercept dosed every eight weeks, with an expected enrollment of 825 patients [4][11] - The company is focusing on a retina-centric strategy built on strong clinical data, regulatory de-risking, and targeting expansive retinal vascular disease markets [2][8] Financial Position - Ocular Therapeutix has a cash runway projected into 2028, prioritizing resources for the clinical development of AXPAXLI and other key programs [7][15] Expert Commentary - Experts have noted the strong enrollment in the SOL-1 study, highlighting the lack of competing trials and the appeal of AXPAXLI's potential durability [8] - The SOL-R study is expected to provide valuable real-world data for physicians regarding the use of AXPAXLI if approved [8]