EyePoint Pharmaceuticals (EYPT) The Baird 2024 Global Healthcare Conference summary

Company overview and clinical progress

• Entering phase III trials for DURAVYU in wet AMD, following strong phase II results using Durasert E delivery technology.

• Phase II DAVIO 2 trial met all primary and secondary endpoints, including non-inferior BCVA, reduced treatment burden, and strong safety profile.

• Phase III design aligns with FDA guidance, using a non-inferiority margin of -4.5 letters and aflibercept as control.

• Two phase III trials (LUGANO and LUCIA) planned, each enrolling ~400 patients, with global site activation and focus on rapid enrollment.

• Inclusion of both treatment-naive and previously treated patients aims to de-risk outcomes and expand labeling.

Regulatory and trial design insights

• FDA has approved the use of sham for masking, with aflibercept as the active control.

• Primary endpoint is non-inferior change in BCVA; rescue criteria focus on vision loss and new fluid, minimizing investigator discretion.

• Dose selection for phase III is 2.7 mg (two inserts), leveraging manufacturing improvements for higher payload per insert.

• Enrollment expected to be balanced between naive and previously treated patients, with robust site activation to accelerate recruitment.

• NDA submission planned with one-year data, followed by two-year safety data.

Market positioning and physician feedback

• DURAVYU positioned as a maintenance therapy with a new mechanism of action, offering six months or longer duration.

• Strong investigator enthusiasm and over 130 sites activated for phase III trials.

• Home OCT technology seen as a positive, reducing visit burden and supporting extended regimens.

• Early adopters expected among high-need patients, with broader use anticipated as label expands.

• Current trial design expected to be acceptable for approval in Europe and Latin America.