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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.Cantor Global Healthcare Conference 2025 summary3 Sep, 2025
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.
DuraVu's unique commercial positioning strategy
How does US manufacturing de-risk DuraVu launch?
What makes the DME opportunity compelling?
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Next EyePoint Pharmaceuticals earnings date
Q3 20256 Nov, 2025
Next EyePoint Pharmaceuticals earnings date
Q3 20256 Nov, 2025
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Frequently asked questions
EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing ophthalmic therapies. The company specializes in sustained-release drug delivery technologies to address serious eye diseases, including conditions affecting the retina and anterior segment of the eye. EyePoint’s product portfolio includes treatments for inflammation and other ocular disorders, and it supports both commercialized products and clinical development programs. The company is headquartered in Watertown, Massachusetts, and its shares are listed on the NASDAQ.
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