Reports Q2 revenue $9.477M, consensus $9.59M. “We continue to make excellent progress in our preparations for the upcoming Phase 3 pivotal trials evaluating DURAVYU(TM) in wet age-related macular degeneration (wet AMD) with over 110 trial sites now committed,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “Our Phase 3 non-inferiority trials are strategically designed to achieve global regulatory and commercial success, generating data that can inform clinical use in the real-world setting. DURAVYU remains on track to be the first sustained release wet AMD program to have two pivotal trials to support a New Drug Application (NDA) submission. Importantly, we also reported positive twelve-month safety and efficacy data from the DAVIO 2 clinical trial of DURAVYU in wet AMD. In addition to a continued favorable safety profile, these robust data demonstrate that the majority of patients treated with a single dose of DURAVYU did not require any supplemental treatment and had a statistically non-inferior change in visual acuity compared to the standard of care on-label aflibercept control. We believe these results underscore the potential for DURAVYU as a sustained six-month maintenance therapy, bolstering our confidence in the design of our Phase 3 program and in DURAVYU’s potential to revolutionize real-world outcomes for patients. We remain on track to dose patients in the Phase 3 LUGANO trial in 2024 with the LUCIA trial patient dosing initiating shortly thereafter.”
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