EyePoint Pharmaceuticals (EYPT) investor relations material

Lead program and clinical trial progress

• DURAVYU, a small molecule tyrosine kinase inhibitor, is in four ongoing phase III trials: LUGANO and LUCIA for wet AMD, COMO and CAPRI for DME.

• Phase II results showed non-inferiority to EYLEA in visual acuity and strong safety, with no drug-related ocular or systemic SAEs in over 190 patients.

• Phase III wet AMD trials enrolled rapidly, with all LUGANO and most LUCIA patients having received their second dose; nearly 50% in LUGANO have received a third dose.

• LUGANO top-line data is expected around August, with LUCIA following two months later; DME trials expect full enrollment in Q3 2024 and top-line results in Q4 2027.

• Retention rates in phase III are strong, with dropout rates below industry standards.

Efficacy, endpoints, and treatment burden

• Primary endpoint for phase III is non-inferiority in change in visual acuity versus EYLEA, with a 4.5-letter margin accepted by both FDA and EMA.

• DURAVYU demonstrated a reduction in treatment burden, with phase II showing up to 40% fewer injections compared to control.

• Secondary endpoint is statistical superiority in reducing treatment burden, calculated as mandated plus supplemental injections from week 8 to week 52.

• Even a 7-8% reduction in treatment burden would be statistically significant; real-world expectations are higher.

• Early DME data showed faster vision gains and greater retinal thinning compared to EYLEA, potentially offering commercial advantages.

Safety profile and risk management

• No DURAVYU-related ocular or systemic SAEs reported in over 190 patients; endophthalmitis cases were linked to aqueous taps or EYLEA supplements, not DURAVYU itself.

• Aqueous humor taps, associated with higher infection risk, were discontinued after phase II for safety.

• Lower injection frequency with DURAVYU may further reduce infection risk compared to standard regimens.