EyePoint, Inc. Q1 FY2023 earnings call

• Clinical progress: Completed enrollment in the Phase II DAVIO 2 trial for wet AMD and accelerated enrollment in the PAVIA trial for NPDR.
• YUTIQ performance: Delivered strong first quarter results with $7.4 million in net product revenue, a 60% increase from Q1 2022.
• EYP-1901 details: Aims to provide long-lasting treatment for eye diseases like wet AMD and NPDR with dosing intervals of six months or longer. Utilizes vorolanib, a TKI with potential neuroprotective and anti-fibrotic benefits, and Durasert E delivery technology.
• Collaboration: Announced a research collaboration with Rallybio to evaluate a C5 complement inhibitor for geographic atrophy using Durasert technology.

The YUTIQ franchise contributed $7.4 million in net product revenue during the first quarter of 2023, representing a 60% increase compared to the first quarter of 2022. The EYP-1901 pipeline segment is focused on clinical trial advancements, with enrollment completed in the DAVIO 2 trial for wet age-related macular degeneration (wet AMD) and accelerated enrollment in the PAVIA trial for non-proliferative diabetic retinopathy (NPDR).

• Expect to fund current and planned operations into the second half of 2024 based on cash and investments on hand.
• Anticipate top line results from the Phase II DAVIO 2 trial in the fourth quarter of 2023.
• Plan to complete enrollment in the Phase II PAVIA trial for NPDR in Q2 2023 with initial top line data in the first half of 2024.
• Intend to initiate a Phase II trial for EYP-1901 in diabetic macular edema (DME) in Q1 2024.

• Forward-looking statements may not align with actual results due to factors such as regulatory uncertainties, clinical trial outcomes, and safety issues.
• Risks outlined in the Risk Factors section of the most recent annual report on Form 10-K and other SEC filings could impact actual performance.

Q: How does the FDA draft guidance for VMD studies impact EyePoint's Phase II plans?

A: EyePoint had a Type C meeting with the FDA prior to starting the DAVIO 2 trial, and the study is aligned with the guidance provided.

Q: What is driving physician enthusiasm for EYP-1901?

A: Physicians are interested in longer treatment intervals (six months or longer) to reduce patient visit burdens for chronic eye diseases.

Q: How does reducing the PAVIA trial size affect assumptions?

A: Reducing the trial size allows for faster progression to pivotal trials while maintaining confidence in efficacy assessment based on preclinical and early clinical data.

Q: When will the Rallybio collaboration enter the clinic?

A: No specific timeline has been disclosed; EyePoint will announce progress when more clarity is available regarding the development of the C5 complement inhibitor program.