EyePoint (EYPT) Study result summary

LUCIA design and visual acuity

• Phase III randomized, double-masked trial enrolled 475 patients; DURAVYU 2.7 mg was dosed every 24 weeks versus aflibercept 2 mg every 8 weeks after loading.

• LUCIA missed its primary BCVA non-inferiority endpoint: gains were 2.5 letters with DURAVYU vs 6.1 with aflibercept; difference -3.7 letters, outside the -4.5-letter margin at blended Weeks 52/56.

Treatment burden and anatomic control

• After loading, average injections were 3.3 with DURAVYU vs 5.3 with aflibercept, a 38% reduction (nominal p<0.0001).

• Through Week 56, 52% of DURAVYU patients were supplement-free, 71% received 0 or 1 supplement, and 83% received 2 or fewer supplements.

• At Week 56, CST change was -66 μm with DURAVYU vs -82 μm with aflibercept, a +16 μm difference.

• Pooled LUGANO/LUCIA results showed 3.2 vs 5.3 average post-loading injections, a 40% reduction; Week 56 CST change was -69 vs -79 μm.

Safety

• No retinal vasculitis, insert migration, anterior chamber opacities or free-floating particles were reported; intraocular inflammation and endophthalmitis each occurred in <1% of both arms.

• Floaters were mostly mild; discontinuation was ~8% in each arm, with none related to DURAVYU or treatment.