EyePoint (EYPT) 44th Annual J.P. Morgan Healthcare Conference summary

Key product and clinical development updates

• DURAVYU, a sustained-release TKI for retinal diseases, is in phase III trials for wet AMD and DME, with top-line data for wet AMD expected mid-2026 and DME trial initiation in Q1 2026.

• The proprietary Durasert delivery system enables ≥6 months of drug durability, multi-mechanism action (VEGF, PDGF, IL-6 inhibition), and room temperature storage.

• Phase II and III trials have shown non-inferiority to Eylea, significant reduction in treatment burden, and robust safety with no serious adverse events in over 190 patients.

• The bioerodible insert delivers 94% drug content, achieves therapeutic levels within hours, and requires no cold storage.

• Pipeline includes EYP-2301, a TIE-2 agonist, advancing alongside DURAVYU.

Market landscape and adoption

• Current market leaders VABYSMO and high-dose Eylea address only part of the need; many patients still require monthly injections, highlighting demand for more durable therapies.

• DURAVYU offers a new paradigm with multi-mechanism action and potential for combination therapy, not just as an anti-VEGF alternative.

• Physician adoption is expected to be aided by the desire to reduce injection frequency and the flexibility to use DURAVYU alongside existing treatments.

• Market penetration is expected to be strong, especially among younger retina specialists seeking workflow improvements.

• 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.

Regulatory and commercial outlook

• Phase III trials for wet AMD and DME are fully enrolled, with rapid recruitment and alignment with FDA and EMA standards.

• Top-line data from the LUGANO and LUCIA trials will be announced separately, with NDA submission targeted within six months of database lock.

• Ongoing safety monitoring by an independent DMC has found no protocol changes necessary, supporting trial integrity.

• Cash reserves and investments of approximately $300 million fund operations through Q4 2027, including all ongoing phase III trials and commercial supply buildout.

• Commercial manufacturing capacity is in place with a new 41,000 sq ft facility in Northbridge, MA, built to FDA and EMA standards and preparing for pre-approval inspection and large-scale production.