EyePoint Pharmaceuticals doses first patient in Phase 2 VERONA Clinical Trial of EYP-1901 for treatment of DME

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EyePoint Pharmaceuticals Inc announced that the first patient has been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic macular edema (DME).

According to the company, EYP-1901 is an investigational sustained delivery therapy containing vorolanib, a selective tyrosine kinase inhibitor formulated in bioerodible Durasert E.

Jay Duker, MD, CEO of EyePoint Pharmaceuticals, noted in the company’s news release the dosing of the first patient “represents another significant milestone in advancing our mission to improve the lives of patients with serious retinal diseases.”

“DME is a common sight-threatening complication of diabetes that can lead to severe vision loss,” he added in the release. “It represents the second diabetic eye disease indication that we are evaluating for potential treatment using EYP-1901.”

Duker also pointed to the need for treatments for DME patients.

“There is a significant need for differentiated and longer-acting treatments for DME patients, as the current standard of care requires frequent intravitreal injections that are burdensome and can result in under-treatment,” he continued in the release.

Duker added the company is encouraged by the growing body of clinical data for EYP-1901 and we are optimistic that EYP-1901 has the potential to change the current treatment paradigm for DME with topline data expected in Q1 2025.

“We look forward to announcing additional milestones for the EYP-1901 clinical programs with topline data from the Phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy expected in the second quarter of 2024 and the initiation of the first Phase 3 pivotal trial in wet age-related macular degeneration (wet AMD) anticipated in the second half of 2024,” Duker concluded.

The company noted in its news release¹ VERONA (NCT06099184) is a randomized, controlled, single-masked, Phase 2 trial of EYP-1901 in DME patients previously treated with a standard-of-care anti-VEGF therapy. The three-arm trial is expected to enroll approximately 25 patients assigned to one of two intravitreal doses of EYP-1901 or an aflibercept control.

According to EyePoint, the primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. The secondary endpoints include safety, change in best corrected visual acuity (BCVA), change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), and change in diabetic retinopathy severity scale (DRSS) over time.

The company noted DME is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME.¹

The current standard of care for patients experiencing DME include intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease.

As a treatment option, the company noted in its news release EYP-1901 currently is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. It 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. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors.

Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order release kinetics for approximately nine months.¹

EyePoint also noted that 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.

Moreover, the recent DAVIO 2 data demonstrated an impressive treatment burden reduction of approximately 88% at 6-months, with over 80% of patients supplement-free or receiving only 1 supplemental anti-VEGF injection through up to 6 months. 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.

EYP-1901 is also being studied in non-proliferative diabetic retinopathy and diabetic macular edema. The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data anticipated in the second quarter of 2024.

Reference:

1. EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 VERONA Clinical Trial of EYP-1901 for the Treatment of Diabetic Macular Edema | EyePoint Pharmaceuticals. EyePoint Pharmaceuticals. Published 2024. Accessed January 10, 2024. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-announces-first-patient-dosed-phase-2-1