Sustained Release Drug Delivery

Search documents
EyePoint Pharmaceuticals (EYPT) FY Earnings Call Presentation
2025-06-30 12:56
DURAVYU Clinical Trials and Data - DURAVYU pivotal Phase 3 trial in wet AMD, LUGANO is fully enrolled, and LUCIA is 60% enrolled and randomized[3] - VERONA Phase 2 trial in DME showed highly positive efficacy and safety data[3] - DAVIO 2 Phase 2 trial showed 89% reduction in treatment burden with 2mg DURAVYU and 85% with 3mg DURAVYU vs 6 months prior[29] - In the VERONA Phase 2 DME trial, DURAVYU 2.7mg demonstrated an early and sustained BCVA improvement of +7.1 letters and CST improvement of -76 microns[47] - In a sub-group analysis of supplement-free patients in the VERONA trial, DURAVYU 2.7mg showed a mean BCVA change from baseline of +7.3 letters and a CST change of -73.7 um[59] Market and Unmet Needs - Over 80% of Retina Specialists indicate undertreatment in wet AMD is due to patient noncompliance, scheduling limitations, or provider preference for less frequent dosing[8] - A delay in treatment of only 5.34 weeks can result in vision loss[9] - By 2030, the global branded market for DME is projected to reach $3.0 billion[11] - By 2050, diabetes-related vision loss is expected to cost $500 million annually in the US[12] Company Financials and Pipeline - EyePoint Pharmaceuticals had $318 million in cash as of March 31, 2025, providing a runway into 2027 post Phase 3 LUGANO/LUCIA data in 2026[3] - LUCIA full enrollment is anticipated in 3Q 2025[5] - LUGANO topline data is anticipated in mid-2026, with LUCIA topline data following in 2H 2026[35]
EyePoint Pharmaceuticals (EYPT) Earnings Call Presentation
2025-06-30 12:54
DURAVYU Program - DURAVYU, a patent-protected vorolanib product utilizing Durasert E technology, is in Phase 3 trials for wet AMD and has a program in DME supported by Phase 2 data[3] - Phase 2 VERONA trial in DME showed a 73% supplement-free rate in the 2.7mg DURAVYU arm compared to 50% in the aflibercept control group[35] - The VERONA trial's 2.7mg DURAVYU treatment demonstrated a clinically meaningful improvement in BCVA of +7.1 letters[35] - The VERONA trial's 2.7mg DURAVYU treatment demonstrated an early and sustained CST improvement of -76 microns[35] Clinical Trials and Pipeline - EyePoint is conducting two global Phase 3 non-inferiority pivotal trials (LUGANO and LUCIA) in wet AMD[3] - Enrollment completion in the EYP-2301 program for serious retinal diseases is expected in the second half of 2025[6] - LUGANO trial is ~1/3 enrolled, and LUCIA is exceeding expectations as of January 2025, with topline data for both Phase 3 pivotal trials anticipated in 2026[65, 66] Financial Status - EyePoint has a strong balance sheet with approximately $370 million in cash and equivalents as of December 31, 2024, providing a cash runway into 2027[3] Market Opportunity - The global market for DME is projected to reach $3.9 billion by 2030[25]