Summary of EyePoint Pharmaceuticals (EYPT) FY Conference - August 13, 2025 Company Overview - **Company**: EyePoint Pharmaceuticals - **Focus**: Development of sustained-release therapies for ocular diseases, specifically targeting wet age-related macular degeneration (AMD) with their drug Duravu Key Points and Arguments Clinical Trials and Drug Development - **Phase Three Trials**: Both Lugano and Lucia trials for Duravu have completed enrollment, including treatment naive and treatment experienced patients, which is expected to positively impact future data readouts [3][4][5] - **Patient Population**: The trials have a 75% treatment naive to 25% previously treated patient ratio, which is considered advantageous for FDA evaluation [8][10][12] - **Safety Profile**: No safety signals were observed in previous trials, and the inclusion of naive patients is not expected to alter safety outcomes [6][42] - **Supplemental Injections**: The criteria for supplemental injections have been simplified based on phase two findings, aiming to reduce the supplemental rate in pivotal trials [13][15][17] Drug Technology - **DuraCert e Technology**: The new bioerodible DuraCert e technology differs from previous DuraCer technology by eliminating the polyamide shell, which is expected to enhance safety and efficacy [20][22][26] - **Drug Composition**: The inserts are now 94% drug and 6% matrix, designed to fully bioerode without leaving harmful residues [27][28][32] Market Expectations and Competitive Landscape - **Regulatory Pathway**: Vorolanib, the active ingredient in Duravu, has been approved in China for kidney cancer but is a new drug entity in the U.S., providing potential advantages in patent protection [44][46] - **Real-World Use**: Duravu is expected to be integrated into existing treatment protocols, potentially allowing for longer intervals between injections compared to current therapies like Eylea and Lucentis [47][49][52] - **Payer Receptiveness**: Payers have shown receptiveness to the idea of a sustained release therapy that reduces treatment burden, which is a significant factor in market adoption [55][56] Financial and Operational Readiness - **Manufacturing Capacity**: EyePoint has established a new manufacturing facility capable of producing hundreds of thousands of inserts annually, with potential expansion to a million inserts [57][59] - **Cash Runway**: The company has sufficient cash to complete pivotal trials and prepare for regulatory approval, with optimism about raising additional funds for commercialization [63][64] Future Outlook - **Data Expectations**: Top-line data from the Lugano trial is expected in mid-2026, with hopes of demonstrating noninferiority or even superiority to Eylea [36][38][62] - **Market Positioning**: The company is optimistic about the potential for rapid uptake of Duravu in the market, especially if pivotal trial results are positive [54][65] Additional Important Information - **Patient Engagement**: Rapid enrollment in trials indicates strong enthusiasm from both doctors and patients for the drug [36] - **Clinical Evidence**: Previous studies suggest that Duravu may provide better visual acuity outcomes compared to existing treatments [41][62]