EyePoint Pharmaceuticals (EYPT) FY Conference Transcript

Summary of EyePoint Pharmaceuticals (EYPT) FY Conference Call - June 10, 2025 Company Overview - EyePoint Pharmaceuticals is a publicly traded company specializing in sustained release drug delivery for retinal diseases, with its lead asset being Duravu, a small molecule tyrosine kinase receptor inhibitor, which is patent protected [2][4]. Key Developments - EyePoint is currently conducting two pivotal Phase III trials for wet age-related macular degeneration (AMD): the Lugano trial, which is fully enrolled with over 400 patients, and the LUCIA trial, which is expected to be fully enrolled by Q3 2025 [3][23]. - The company has a strong cash position of $318 million, providing a runway into 2027, which is approximately one year post data from the Phase III trials [4]. Product Pipeline - Duravu is being tested for diabetic macular edema (DME) and has shown positive efficacy and safety data in the Phase II VORONA trial [4][28]. - EyePoint is advancing EYP2301, a small molecule TIE II agonist, for serious retinal diseases [5]. Market Opportunity - The current market for DME is approximately $3 billion, with a significant percentage of patients experiencing delayed or missed visits, leading to visual loss [8]. - There is a growing need for durable treatments in both wet AMD and DME due to the aging population and the burden of frequent intravitreal injections [6][7]. Clinical Trial Insights - The DuraVu delivery system offers continuous dosing with zero-order kinetics, allowing for a sustained release of the drug for a minimum of six months [10][13]. - The Phase II trial results for wet AMD showed that the two and three milligram doses of Duravu had similar visual acuity outcomes compared to EYLEA, with a significant reduction in treatment burden of about 80% [18][19]. - In the VORONA trial for DME, the high dose of Duravu demonstrated early improvement in visual acuity and anatomy, achieving a primary endpoint of extended time to rescue compared to aflibercept [28][44]. Regulatory and Manufacturing Updates - EyePoint has received approval from both the FDA and EMA for its trial protocols, indicating a strong regulatory position [23]. - The company has established a new manufacturing facility in Northbridge, Massachusetts, capable of producing over a million inserts annually, which is crucial for supporting future commercial activities [46][47]. Safety and Efficacy - The safety profile of Duravu has been favorable, with no serious adverse events reported in the trials conducted to date [15][28]. - The drug's formulation avoids problematic components like PEG and PLGA, which have been associated with adverse effects in sensitive patients [14]. Future Outlook - EyePoint plans to start pivotal trials for DME in 2026 and aims to submit a New Drug Application (NDA) for Duravu at the end of one year from the start of the Phase III trials [45][48]. - The company is optimistic about the upcoming trial results and their potential impact on the treatment landscape for retinal diseases [48].