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Positive EOP2 meeting with FDA completed in April 2024; waiting for final FDA review* Key trial design elements agreed upon with FDA: Two pivotal, non-inferiority trials vs. aflibercept control 12-month primary efficacy endpoint (blended) basis of NDA submission DURAVYU re-dosing at six-month intervals 4 total doses Masking strategy We remain on-track to initiate the LUGANO trial (US) in 2H 2024 with LUCIA trial (US/OUS) to follow. *Timing TBD based on extenuating circumstances with the interim FDA Division of Ophthalmology leadership required for sign-off.
SAE, serious adverse event; AE, adverse event; IVT, intravitreal injection PRELIMINARY DATA CUT PENDING FINAL ANALYSIS 1- As of November 7, 2023 data cut 2- as deemed by the investigator No reported DURAVYU-related ocular or systemic SAEs Four ocular SAEs reported in a study eye none deemed DURAVYU related2 >97% of AEs reported were mild (Grade 1 or 2) and generally expected with IVT No insert migration into the anterior chamber No retinal occlusive vasculitis Low patient discontinuation rate of 4% up to week 32 No discontinuations were related to DURAVYU treatment 2024 EyePoint Pharmaceuticals, Inc.
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