EyePoint (EYPT) Study result summary

Introduction and Program Overview

• DURAVYU is being developed for wet AMD and DME, targeting a ~$15B total addressable market, with multiple Phase 3 programs underway and a commercial cGMP facility ready for US launch.

• Four Phase 3 trials were enrolled in under seven months, following a non-inferiority regulatory pathway similar to recent FDA approvals.

• DURAVYU uses a bioerodible Durasert insert for sustained drug release for at least six months.

Study Design and Methodology

• LUGANO and LUCIA are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials in wet AMD, enrolling over 900 patients; LUGANO enrolled 432 patients, randomized 1:1 to DURAVYU every six months or aflibercept every two months.

• All patients received an EYLEA loading phase before randomization; primary endpoint was non-inferiority in mean change in BCVA at weeks 52/56 (margin: -4.5 letters).

• Key secondary endpoints included safety, reduction in treatment burden, supplement-free rates, and anatomical outcomes, with studies planned for two years for safety.

• Both treatment-naive and previously treated eyes were included, with a 75/25 ratio; baseline characteristics were balanced, though DURAVYU arm had slightly more glaucoma history.

• DURAVYU is delivered via standard intravitreal injection, similar to current anti-VEGF therapies.

Efficacy and Primary Endpoint Results

• DURAVYU did not meet the non-inferiority margin in the full analysis set due to a 4% asymmetric cohort (nine patients) with severe vision loss from non-wet AMD causes; no similar vision loss was observed in the aflibercept arm.

• Excluding these nine patients, DURAVYU was non-inferior to aflibercept in BCVA change (2.4 letter difference, CI below -4.5 margin, nominal p=0.0096).

• Median change and pre-specified analyses also showed non-inferiority when excluding outliers or in supplement-free patients.

• In the total population, the BCVA difference was 3.8 letters, with the confidence interval crossing the non-inferiority threshold.