Keep An Eye On EYPT - Diabetic Macular Edema, Wet AMD Trial Results Awaited

(RTTNews) - EyePoint Pharmaceuticals Inc. (EYPT), which reported positive interim 16-week data from its phase II VERONA clinical trial last October, expects to report full topline results in the first quarter of 2025.

VERONA is a phase II trial evaluating the company's lead investigational product Duravyu in diabetic macular edema patients previously treated with a standard-of-care FDA-approved anti-VEGF treatment, like intravitreal Aflibercept. 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.

Diabetic macular edema (DME) is the primary cause of vision loss among individuals with type 1 and type 2 diabetes. DME occurs when damaged blood vessels leak fluid into the macula, the central part of the retina essential for sharp vision required for everyday activities like driving or reading. This fluid buildup leads to retinal swelling, which can cause blurred vision and, if left untreated, may result in significant vision loss or blindness. Roughly 28 million people are afflicted with DME globally.

The VERONA trial enrolled 27 patients assigned to one of two intravitreal doses of Duravyu (1.3mg or 2.7mg) or Aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental Aflibercept injection up to 24 weeks, based on established supplement criteria. Key secondary endpoints include safety, mean change in best corrected visual acuity (BCVA), mean change in central subfield thickness (CST) as measured by optical coherence tomography (OCT) and change in diabetic retinopathy severity scale (DRSS) over time.

According to the interim results reported last October, Duravyu 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) and anatomical control versus the Aflibercept control arm. As mentioned above, the company expects to report full topline data from the VERONA trial this quarter (Q1 2025).

Duravyu is also being explored in two global phase III pivotal trials in wet AMD, dubbed LUGANO and LUCIA.

Wet age-related macular degeneration (wet AMD) is a major cause of vision loss and permanent blindness in people over 50. It happens when abnormal blood vessels grow into the macula (the part of the retina responsible for sharp vision) and leak blood or fluid, which can lead to serious vision problems. About 196 million people worldwide are affected by wet AMD.

Enrollment in the LUGANO and LUCIA trials is expected to be completed in the second half of this year, with topline data anticipated in 2026.

Cash position

The company's cash on hand as of December 31, 2024, was roughly $370 million, which is expected to be sufficient to fund operations into 2027.

Formerly known as pSivida Corp., the company changed its name to EyePoint Pharmaceuticals Inc. in March 2018.

EYPT has traded in a range of $6.90 to $30.99 in the last 1 year. The stock closed yesterday's trading at $7.73, down 1.28%.