EyePoint Pharmaceuticals, Inc. (EYPT), Wednesday announced positive six-month results from the ongoing Phase 2 VERONA clinical trial, evaluating Duravyu for the treatment of diabetic macular edema or DME.
The trial enrolled 27 patients who were assigned to one of two intravitreal 1.34mg or 2.7mg doses of DURAVYU or aflibercept control.
The company said that the study met its primary endpoint with both 1.34 mg and 2.7 mg doses of Duravyu demonstrating extended time to first supplemental injection compared to aflibercept control.
Notably, the 2.7mg dosage of Duravyu showed immediately and meaningfully improvement in both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety.
Based on these results, the company expects to initiate a Phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options.
Also, EyePoint plans to meet the FDA in the second quarter for potential initiation of a Phase 3 clinical trial later in 2025.
In the pre-market hours, EyePoint's stock is dropping 21.62 percent, to $6 on the Nasdaq.
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