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EyePoint Pharmaceuticals (EYPT) investor relations material
EyePoint Pharmaceuticals 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key product and clinical development updates
DURAVYU, a sustained-release, multi-mechanism TKI for retinal diseases, is in phase III trials for wet AMD and DME, with topline wet AMD data expected mid-2026 and DME enrollment beginning Q1 2026.
The proprietary Durasert delivery system offers ≥6 months of sustained drug release, room temperature storage, and is used in four FDA-approved products.
DURAVYU blocks VEGF, PDGF, and IL-6, with robust efficacy and safety demonstrated in multiple trials, including no severe adverse events in over 190 patients.
Phase II and III trials show non-inferiority to Eylea/aflibercept, significant reduction in treatment burden, and robust safety.
DME program leverages positive Phase 2 VERONA data, with global phase III trials (COMO and CAPRI) designed for rapid enrollment and regulatory success.
Market landscape and commercial strategy
Market need remains for longer-lasting therapies, as current drugs require frequent injections and many patients cannot extend intervals beyond eight weeks.
DURAVYU's multi-MOA and six-month dosing interval are expected to drive adoption, especially among retina specialists seeking to reduce patient load.
Educational efforts will focus on integrating DURAVYU into existing treatment paradigms, emphasizing its compatibility with anti-VEGF therapies.
DURAVYU is positioned to capture meaningful share in the $15B anti-VEGF market, with a best-in-class profile and first-mover advantage in key indications.
Competitive differentiation is based on trial design, multi-MOA, and robust safety/efficacy data compared to other TKI programs.
Manufacturing and commercialization
Commercial manufacturing scale-up is underway in a new 41,000 sq ft Northbridge, MA facility built to FDA and EMA standards, supporting NDA filing and launch.
Registration batches are underway, and the facility is designed for scalability and regulatory compliance.
Commercial supply buildout is included in financial projections, with facility readiness for initial launch.
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