Why Is EyePoint Pharmaceuticals Stock Plummeting On Monday?

On Monday, EyePoint Pharmaceuticals Inc. EYPT announced the topline results of its Phase 2 PAVIA trial evaluating Duravyu (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). 

The data demonstrated that Duravyu has a biologic effect in patients with NPDR and a favorable safety and tolerability profile; however, the trial did not meet the pre-specified primary endpoint. 

The company plans to provide an update on the path forward for Duravyu as a potential treatment in NPDR following a review of the full 12-month data.

PAVIA topline interim results include:

• 86% of patients in the 3mg arm and 80% of patients in the 2mg arm demonstrated stable or improved disease at nine months versus 70% in the control arm.
• 0% of patients in the 3mg arm and 5% of patients in the 2mg arm worsened ≥2-step at nine months vs. 10% in the control arm.
• 5% of patients in the 3mg arm and 0% of patients in the 2mg arm achieved a ≥2-step improvement in DRSS score at nine months versus 5% in the control arm.
• Continued favorable safety and tolerability profile with no Duravyu-related ocular or systemic serious adverse events reported. No cases of endophthalmitis or retinal vasculitis (occlusive or non-occlusive) were observed.

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, LUGANO, anticipated in the second half of 2024, the second global Phase 3 pivotal trial in wet age-related macular degeneration, LUCIA, to follow, and the readout of topline data from the Phase 2 VERONA trial in diabetic macular edema anticipated in the first quarter of 2025.

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Price Action: EYPT shares are down 29.9% at $13.84 during the premarket session at last check Monday.