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EyePoint Pharmaceuticals (EYPT) investor relations material
EyePoint Pharmaceuticals Cantor Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Clinical development progress
DuraVu, leveraging DuraCert technology, advanced from Phase I to two global Phase III trials in four years, each enrolling over 400 patients in record time.
Both Phase III trials, Lugano and Lucia, are identically designed with no protocol changes since inception, focusing on non-inferiority to aflibercept.
Lucia includes about 20% ex-U.S. patients, with overall 90% U.S. representation across both trials, aligning with FDA preferences.
Redosing is every six months for two years, aiming for an unlimited label; NDA submission will use 12-month data, supplemented by 24-month results.
Phase III data readouts are expected in Q3 2025, with Lugano first, followed by Lucia, enabling a rapid NDA filing.
Regulatory and commercial strategy
Both U.S. FDA and EU regulators have approved the clinical trial protocols, supporting global regulatory alignment.
U.S. launch is prioritized, with plans to commercialize independently; ex-U.S. partnerships will be considered later.
Commercial positioning emphasizes DuraVu’s unique TKI mechanism, offering a new MOA in wet AMD, and potential for use alongside anti-VEGF therapies.
Market strategy targets reduction in treatment burden and addresses unmet needs in a $14–15B wet AMD market.
DuraVu aims to be the first new MOA in wet AMD in 15 years, with potential for broad adoption due to its durability and differentiated profile.
Manufacturing and operational readiness
A new 41,000 sq. ft. commercial manufacturing facility in Massachusetts is operational, supporting U.S. and future global supply.
Registration batches are underway, with preparations for pre-approval inspection and commercial launch.
Both the product and key API are U.S.-manufactured, minimizing tariff exposure and ensuring supply chain control.
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