EyePoint Pharmaceuticals (EYPT) R&D Day 2024 summary

Company and Product Overview

• Focused on drug delivery for retinal diseases using patented Durasert E technology, with a strong financial position of ~$280 million in cash and no debt.

• Lead asset DURAVYU (vorolanib intravitreal insert) targets wet AMD, with multi-billion dollar market potential and is in Phase 3 development.

• DURAVYU uses a fully bioerodible insert, offers ambient storage, zero-order drug release, and is administered via standard intravitreal injection.

• Pipeline includes EYP-2301 (razuprotafib) for diabetic eye diseases, DME, and early-stage complement inhibition programs.

• Commercial manufacturing facility built to FDA and EMA standards is under construction to support clinical and future commercial supply.

Clinical Trial Results and Safety

• Phase II DAVIO 2 trial in wet AMD showed statistically non-inferior visual acuity outcomes to aflibercept, robust anatomical control, and significant reduction in treatment burden (up to 89%).

• About half of DURAVYU-treated eyes remained supplement-free for 12 months after a single injection, with stable vision and anatomy.

• Safety profile remains excellent, with no drug-related ocular or systemic serious adverse events, and no cases of retinal vasculitis or vascular occlusions.

• Sub-group analyses showed numerically better visual and anatomical outcomes in supplement-free eyes compared to aflibercept.

• DURAVYU demonstrated strong disease control even in tough-to-treat patient populations.

Phase III Program and Regulatory Alignment

• Two global, randomized, double-masked, non-inferiority trials (LUGANO and LUCIA) will compare DURAVYU to aflibercept, each enrolling ~400 patients, including both treatment-naive and previously treated individuals.

• Primary endpoint is mean change in BCVA at 12 months; secondary endpoints include safety, reduction in treatment burden, supplement-free rates, and anatomical stability.

• FDA alignment achieved on trial design and non-inferiority approval pathway, with protocol submitted and no outstanding regulatory issues.

• Phase 3 program is designed to support global regulatory and commercial success, with NDA submission planned upon completion.

• Phase 3 LUGANO and LUCIA pivotal trials are set to begin in 2H 2024.