EyePoint Pharmaceuticals (EYPT) TD Cowen 46th Annual Health Care Conference summary

Recent clinical trial progress and highlights

• Dosed patients in both phase III diabetic macular edema (DME) trials, COMO and CAPRI, in Q1 as planned, targeting a $3 billion US market opportunity.

• DME trials are international, enrolling about 240 patients each, leveraging safety data from wet AMD trials to keep sample size low.

• Full enrollment for both DME trials expected by Q3 2024, with top-line data anticipated in Q4 2027.

• Wet AMD trials (LUGANO and LUCIA) are fully enrolled, with low dropout rates and positive masked safety data; LUGANO top-line results expected around August, LUCIA about eight weeks later.

• All clinical sites from wet AMD trials agreed to participate in DME trials, indicating strong site confidence in the drug's safety and efficacy.

Mechanistic insights and differentiation

• New mechanistic finding: the drug is a potent JAK1 inhibitor, leading to significant IL-6 blockade, which may differentiate it in DME and wet AMD.

• IL-6 is implicated in uveitis and inflammatory macular edema; blocking IL-6 may provide additional therapeutic benefit.

• The drug is the only sustained-release, repeatable anti-VEGF, anti-IL-6, and anti-PGF agent in development for these indications.

• Additional mechanistic data will be presented at ARVO, with ongoing studies to further characterize IL-6 blockade.

Phase II learnings and phase III expectations

• Phase II data showed non-inferiority to EYLEA in efficacy, with a non-inferiority margin well within regulatory requirements.

• No ocular or systemic serious adverse events reported in 191 patients across four trials, supporting a strong safety profile.

• Phase III trials focus on three endpoints: non-inferiority in efficacy, safety, and superiority in reducing treatment burden.

• Improved supplement criteria and inclusion of more treatment-naive patients in phase III expected to reduce supplemental injections.

• Even a modest reduction in treatment burden (as low as 7-8%) would be statistically significant due to strong study power.