Summary of EyePoint Pharmaceuticals (EYPT) Conference Call - September 02, 2025 Company Overview - EyePoint Pharmaceuticals specializes in drug delivery systems for ocular diseases, particularly focusing on wet age-related macular degeneration (AMD) [2][3] - The company has developed a fully bioerodable insert containing Verolanib, a small molecule tyrosine kinase inhibitor targeting all VEGF receptors [2] Key Trials and Market Potential - EyePoint is currently conducting two identical Phase 3 trials for wet AMD, with a market size of approximately $10 billion annually in the U.S. [2][3] - Both trials have been fully enrolled, achieving the fastest enrollment rates on record for wet AMD trials, approximately seven months [3][4] - The primary endpoint of the trials is non-inferiority in visual acuity compared to aflibercept (Eylea) [2][20] Enrollment and Trial Design - The company attributes the rapid enrollment to strong Phase 2 data and effective trial design, including a patient-centric approach [3][12] - The trials include rescue criteria for patients losing vision, allowing supplemental injections to prevent long-term vision loss [12][16] Expected Outcomes and Safety - The non-inferiority margin is set at -4.5 letters, with previous Phase 2 data showing a lower limit of around 2.6 letters [21] - Over 190 patients have been treated with no ocular or systemic serious adverse events (SAEs) attributed to the drug or insert [22] - The Data Safety Monitoring Committee has recommended no changes to the trial protocols, indicating no unexpected safety issues [22] Treatment Burden and Commercial Success - A significant reduction in treatment burden is expected, with Phase 2 data indicating an 80% reduction compared to Eylea [22][23] - The company aims for at least a 50% reduction in treatment burden to achieve commercial success [23] Integration into Clinical Practice - The expected administration interval for the new treatment is six months, with potential for some patients to go a full year without additional injections [25][26] - The treatment strategy will likely involve a combination of existing anti-VEGF therapies and the new insert, allowing for individualized patient care [28][49] Manufacturing and Supply Capacity - EyePoint's manufacturing facility in Northbridge, Massachusetts, is capable of producing nearly one million inserts annually, sufficient to meet global demand [41][42] - The facility is being prepared for FDA inspection and potential commercial launch [42] Competitive Positioning - EyePoint believes it is positioned to be the first to file for approval among competitors developing long-acting inserts for wet AMD, with a potential launch by the end of 2027 [34][35] Future Developments - The company plans to initiate pivotal trials for diabetic macular edema (DME) in 2026, following successful Phase 2 results [57][58] - EyePoint is also exploring opportunities in other retinal diseases, although financial considerations have led to the discontinuation of some programs [66] Upcoming Catalysts - Key upcoming events include presentations at eye meetings and updates on safety and demographic data from the Phase 3 trials [68][69] - The company plans to release data from the two Phase 3 trials separately to maximize impact [70] Conclusion - EyePoint Pharmaceuticals is on track to potentially revolutionize the treatment of wet AMD with its innovative drug delivery system, backed by strong trial data and a robust manufacturing strategy [2][34][42]

Core Viewpoint - The company Fuhong Hanlin (复宏汉霖) announced that its HLX04-O injection has met the primary endpoint in a Phase III clinical study for wet age-related macular degeneration (wAMD) in Chinese patients [1][2]. Group 1: Clinical Study Details - The study was a multicenter, randomized, double-blind, positive-controlled non-inferiority trial comparing HLX04-O with Ranibizumab (雷珠单抗) in wAMD patients [2]. - Patients were randomly assigned in a 1:1 ratio to receive either HLX04-O (1.25 mg) or Ranibizumab (0.5 mg) via intravitreal injection every four weeks for one year, with the primary endpoint being the change in best-corrected visual acuity (BCVA) from baseline at week 48 [2]. - Results showed that the average letter score improvement in the HLX04-O group at week 48 was non-inferior to that of the Ranibizumab group, achieving the primary endpoint [2]. Group 2: Product Development and Market Potential - HLX04-O is developed based on the company's existing product Hanbeitai (汉贝泰, Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [3]. - In addition to the successful Phase III study, international multicenter Phase III trials for HLX04-O are ongoing in several European countries, Australia, the United States, and mainland China [3]. - As of the announcement date, there are no Bevacizumab products approved for wAMD in mainland China, and the projected sales for wAMD treatments in China for 2024 are approximately RMB 4.18 billion [3].