EyePoint Pharmaceuticals, Inc. announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E. These data are being presented in two sessions at the Angiogenesis, Exudation, and Degeneration 2024 Meeting held virtually February 3, 2024. The presented analyses of the data reveal: In the sub-group of patients who were supplement-free up to 6 months, the EYP-1901 groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP -1901 in previously treated patients with wet AMD.

The Company remains on track to report additional clinical milestones with EYP-1901 this year with the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease.

EYP-1901 delivers vorolanib, a select and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint's proprietary sustained-release Durasert E? technology.orolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and OCT, and a favorable safety profile. The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program to Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024.

For EyePoint, this includes uncertainties regarding the timing and clinical development of product candidates, including EYP-1901 and EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related maculardegation (wet AMD) and non-proliferative diabetes retinopathy (NPD R) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 andEYP-2301; the success of current and future license agreements; dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the impact of general business and economic conditions; absence of dividends; the effect of general business and economic conditions.