EyePoint (EYPT) investor relations material

Clinical development updates

• Phase III wet AMD trial (LUGANO) top-line results expected in August, with LUCIA to follow two months later; both are non-inferiority trials against EYLEA and include both treatment-naive and previously treated patients.

• DURAVYU (EYP-1901) is dosed at 2.7 mg every six months, aiming for a six-month dosing label; recent safety reviews by DSMC found no protocol changes necessary.

• Phase II data showed non-inferiority to EYLEA in visual acuity and a significant reduction in treatment burden, with a 35% reduction in injections.

• Modifications in phase III include refined rescue criteria based on phase II learnings, focusing on vision loss with fluid or hemorrhage, and stricter controls on discretionary supplementation.

• Repeat dosing is designed for every six months, with two years of data required for full label approval; NDA submission targeted for early next year.

Product profile and differentiation

• DURAVYU uses a bio-erodible Durasert E delivery system with 94% drug payload, enabling room temperature storage and steady zero-order drug release for at least six months.

• The drug blocks all VEGF receptors, PDGF, and JAK1, potentially offering advantages in fibrosis and IL-6 pathway inhibition, which is particularly relevant for DME.

• Early phase II DME data showed a four-letter visual acuity improvement and drier retinas compared to EYLEA at week four, suggesting an IL-6 advantage.

• Sustained release is expected to improve compliance and visual outcomes, especially in DME where IL-6 is more strongly implicated.

Commercialization and financial outlook

• Plans are in place for a U.S. launch with an in-house sales force targeting 2,400 retinal specialists, supported by a new Chief Commercial Officer and a dedicated manufacturing facility.

• Cash runway extends into Q4 2027, covering all ongoing phase III trials; multiple value inflection points are anticipated, including trial readouts and NDA submission.

• Full enrollment in the DME trial is expected in Q3, with readout in Q4 2027.