Announcement • Aug 18
EyePoint Announces Topline Data From LUGANO Phase 3 Clinical Trial For DURAVYU In Wet AMD
EyePoint, Inc. issued a press release announcing topline data for LUGANO, one of its pivotal Phase 3 clinical trials evaluating DURAVYU for wet age-related macular degeneration (wet AMD). 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 Fourth Quarter 2026 with potential FDA New Drug Application submission planned for First Half 2027. 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 letters. 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. Key secondary endpoints including a favorable safety profile, reduction in treatment burden, supplement-free rates, and anatomic controls were achieved. DURAVYU observed to be safe and well tolerated with repeat dosing in patients. No difference in cataracts, elevated intraocular pressure, or intraocular inflammation between study and control group. No observed occurrences of insert migration, anterior chamber opacities, free-floating drug particles, retinal vasculitis, or severe intraocular inflammation (IOI). 42% reduction in treatment burden, achieving superiority versus on-label aflibercept (nominal p-value<0.0001) compared to a maximum possible reduction of 60%. This reduction translates to two fewer injections on average in DURAVYU patients versus on-label aflibercept up to Week 56. 76% of DURAVYU patients were supplement-free up to Week 32. 94% of DURAVYU patients received zero or one supplement up to Week 32. 54% of DURAVYU patients were supplement-free up to Week 56. 79% of DURAVYU patients received zero or one supplement up to Week 56. Pre-specified analysis of change in BCVA from baseline to average Week 52/56 in supplement-free patients showed that DURAVYU was non-inferior (nominal p-value=0.0035) versus on-label aflibercept. Strong anatomic control demonstrated DURAVYU's potency with a mean difference of 4 microns versus on-label aflibercept control in central subfield thickness (CST) at Week 56. The 54% of DURAVYU eyes that were supplement free up to week 56 showed only a 3-micron difference in CST compared to the on-label aflibercept control. DURAVYU demonstrated durable efficacy results with stable retinal anatomy maintained through Week 56, avoiding the sawtooth pattern commonly seen with intermittent anti-VEGF therapy. The LUGANO results are clinically meaningful because the trial compared DURAVYU to on-label aflibercept, the current gold standard control group in wet AMD trials. Nearly 80% of DURAVYU-treated patients received one or no supplemental injections through Week 56. Disease control with this degree of durability, coupled with a favorable safety profile, would meaningfully reduce the treatment burden for patients. DURAVYU's ability to control disease well in the majority of patients with a six-month redosing interval represents a significant advance for patients with wet AMD. DURAVYU demonstrated durable efficacy results with stable retinal anatomy maintained through Week 56, avoiding the sawtooth pattern commonly seen with intermittent anti-VEGF therapy. In addition, the supplement-free anatomic and visual outcomes further validate the potency of DURAVYU. EyePoint plans to present additional details on the LUGANO dataset, including subgroup-analyses, at major retina conferences in the coming months, beginning at the Retina Society 59th Annual Scientific Meeting from September 23-26, 2026. The Company remains on track to report topline data from the second wet AMD pivotal Phase 3 LUCIA trial in the Fourth Quarter of 2026. The Company anticipates potentially filing an NDA for DURAVYU for the potential treatment of wet AMD in the First Half of 2027. Additionally, the pivotal Phase 3 COMO and CAPRI clinical trials for DURAVYU in diabetic macular edema (DME) rapidly completed enrollment, with topline data for both trials anticipated in the Fourth Quarter of 2027. LUGANO and LUCIA are identical, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including both treatment naive and treatment experienced patients. Enrollment is complete in both trials with over 900 patients enrolled. At Day 1, patients are randomized 1:1 to receive either DURAVYU 2.7mg every six months or on-label aflibercept as control. All active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal Phase 3 trials evaluating 6-month redosing in both trials over two years. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is non-inferiority in the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline.
