EyePoint Pharmaceuticals, Inc. announced topline results of its Phase 2 PAVIA clinical trial evaluating DURAVYU (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). The company look forward to providing additional clinical and regulatory updates on the NPDR program in the coming months. The Company remains on track to reach additional clinical milestones with DURAVYU with the initiation of the first Phase 3 pivotal trial in wet AMD, LUCIA, to follow, and with the readout of topline data from the Phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2025.

DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.

DURAVYU delivers vorolanib, a selective 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. DURAVYU are currently being evaluated in three ongoing Phase 2 clinical trials in wet age-related macular degeneration (wet AMD), non-proliferative diabetes retinopathy (NPD RME) and diabetic macular edema (DME). In December 2023, the Company reported positive topline results from its Phase 2 DAVIO 2 clinical trial in wet AMD, which showed all primary and secondary endpoints were met.

The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program into Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024. For EyePoint, this includes statements about the deficiency of existing cash resources through topline data for Phase 3 clinical trials for DURAVYU in wet AMD; expectations regarding the timing and clinical development of product candidates, including DURAVYU and EYP-2301; the potential for DURAVYU as a novel sustained delivery treatment for serious eye diseases, including wet age-related maculardegation (wet AMD) and non-proliferativeabetic retinopathy (NPDC) and diabetic macular edem (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 DURAVYU andEYP-2301; the success of current and future license agreements; dependence on contract research organizations, co-inferiority clinical trial, and the commitment to the development of the company's product candidates, and the commitment of the company's product candidates.