Page 1

EYE POINT EyePoint Announces Topline Data from LUGANO , the First of Two Pivotal Phase 3 Clinical Trials for DURAVYUTM 2.7mg in Wet AMD Aug 17 , 2026 -DURAVYU was non - inferior to on - label aflibercept control ( nominal p - value = 0.0096 ) in an ad hoc analysis excluding a 4 % asymmetric cohort ( 9 of 211 patients ) who experienced vision loss ( ≥ 15 letters ) unrelated to wet AMD ; primary endpoint not achieved in full dataset , confounded by this asymmetric cohort - - LUGANO demonstrated clinically meaningful results that reinforce DURAVYU's potential to improve the treatment paradigm in wet AMD , with compelling key secondary endpoints , including reduction in treatment burden , supplement - free rates , favorable safety profile with redosing , and strong anatomic control through Week 56 compared to on - label aflibercept - - 42 % reduction in treatment burden achieving superiority versus on - label aflibercept ( nominal p - value of < 0.0001 ) – - - 76 % of DURAVYU patients were supplement - free up to Week 32 - - 54 % of DURAVYU patients were supplement - free and 79 % received 0 or 1 supplement up to Week 56 ; pre - specified analysis on change in BCVA in the supplement - free DURAVYU patients showed non - inferiority to supplement - free aflibercept ( nominal p - value = 0.0035 ) — - Topline data from LUCIA , the second pivotal Phase 3 clinical trial in wet AMD , expected in Q4 2026 with potential FDA New Drug Application submission planned for 1H 2027 - - Conference call to discuss the results to be held today at 8:00 a.m. EDT - WATERTOWN , Mass . , Aug. 17 , 2026 ( GLOBE NEWSWIRE ) -- EyePoint , Inc. ( Nasdaq : EYPT ) , a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases , today announced topline results from LUGANO , the first pivotal Phase 3 clinical trial for DURAVYU ™ ( vorolanib intravitreal insert ) for the treatment of wet age - related macular degeneration ( wet AMD ) . DURAVYU was non - inferior to on - label aflibercept ( nominal p - value = 0.0096 ) in an ad hoc analysis excluding a 4 % asymmetric cohort ( 9 of 211 patients ) who experienced vision loss ( ≥ 15 letters ) unrelated to wet AMD . Despite the outperformance in key secondary endpoints , the primary endpoint of change from baseline in best corrected visual acuity ( BCVA ) versus 2 mg aflibercept on - label control was not achieved in the full dataset , confounded by this asymmetric cohort . In contrast , no patients experienced vision loss ( ≥ 15 letters ) unrelated to wet AMD in the aflibercept control arm . In prior reported similar scale pivotal Phase 3 trials , approximately 3-5 % of aflibercept patients lost ≥15 letters¹ , indicating meaningful overperformance of the on - label aflibercept control group in LUGANO that also contributed to the primary endpoint performance . LUGANO demonstrated clinically meaningful results that reinforce DURAVYU's potential to improve the treatment paradigm in wet AMD , with compelling key secondary endpoints in reduction in treatment burden , supplement - free rates , a favorable safety profile with redosing , and anatomic control through Week 56 compared to on - label aflibercept . These results represent a meaningful improvement to current wet AMD standard of care . " We are pleased to see that DURAVYU provided clinically meaningful results in the LUGANO trial . The outstanding outcomes across key secondary endpoints , paired with visual improvement , reinforce our confidence in DURAVYU's potential to transform the current wet AMD treatment paradigm , " said Jay S. Duker , M.D. , President and CEO of EyePoint . " While the primary endpoint result for the full dataset was unexpected , the consistently positive results from the pre - specified secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for DURAVYU as a new potential therapeutic option for wet AMD . We look forward to a potential New Drug Application ( NDA ) filing with FDA in the first half of 2027 , pending LUCIA results in the fourth quarter of 2026. " Key Secondary Endpoints Across All Patients Key secondary endpoints including a favorable safety profile , reduction in treatment burden , supplement - free rates , and anatomic controls were achieved .