Texas Retina’s Ashkan M. Abbey, MD, presented “DAVIO 2: Year 1 Results from a Phase 2, Multicenter, Non-Inferiority Trial of EYP-1901 (Vorolanib Intravitreal Insert) versus Aflibercept for Previously-Treated Wet Age-Related Macular Degeneration” at the Hawaiian Eye and Retina 2025 meeting held January 18-24, 2025, in Kauai, Hawaii.

The clinical trial is a Phase II, randomized, double-masked, controlled multicenter study of EYP-1901 vs. aflibercept in previously treated wet age-related macular degeneration (AMD). EYP-1901 (Duravyu) is an investigational sustained delivery maintenance treatment for wet AMD that combines vorolanib, a selective tyrosine kinase (anti-VEGF) inhibitor, with bioerodible Durasert E™.

“EYP-1901 combines the potent, pan-VEGF inhibitor vorolanib with bioerodible Durasert E technology for sustained intravitreal drug delivery with the goal of helping patients go longer between treatments,” shares Dr. Abbey. “It is designed to provide controlled release over a period of at least 6 months. With EYP-1901, vorolanib reaches target tissues within hours of administration and is continuously released at a consistent dose.”

The DAVIO 2 Trial Year 1 Results
The DAVIO 2 trial’s primary endpoint was statistically noninferior best corrected visual acuity (BCVA) after treatment with EYP-1901 compared to aflibercept injection alone at months 7 and 8, averaged. All patients were eligible for supplemental aflibercept injections starting at week 12, per prespecified vision and anatomical criteria.

In his presentation, Dr. Abbey shared the following key findings from the DAVIO 2 study:

  • Patients who participated were heavily treated with anti-VEGF injections prior to entering the trial.
  • Overall, including supplementation, patients who received EYP-1901 experienced an over 85% reduction in treatment burden relative to their pre-trial treatment.
  • Compared with the aflibercept arm, treatment burden was ~80% lower in those treated with EYP-1901.
  • At 6 months following EYP-1901 insertion, about two-thirds of EYP-1901–treated eyes were supplemental injection-free (up to month 8).
  • Central subfield thickness (CST) was stable through month 8 with EYP-1901. CST, a measurement of the thickness of the central part of the macula, is an indicator of fluid buildup and AMD severity.
  • With only a single injection of EYP-1901, vision outcomes were nearly identical at month 12.
  • EYP-1901 demonstrated a favorable safety profile.

Texas Retina was one of the top enrolling centers for the DAVIO 2 study.

“We continue to look for ways to improve care for our patients with wet AMD,” explains Dr. Abbey. “While anti-VEGF injections like aflibercept are effective, they must be dosed on average every two months, which can be challenging for some patients. A delayed or missed appointment can leave them with no active drug to prevent disease progression and the associated vision loss. So far, EYP-1901 appears to substantially reduce the treatment burden while also demonstrating a favorable safety profile.”

Phase III Research on EYP-1901
EyePoint Pharmaceuticals, the maker of EYP-1901, launched a Phase III study of the drug called LUGANO, and Dr. Abbey dosed the first patient in October 2024. Texas Retina continues to enroll patients with wet AMD, previously treated or treatment-naïve, for the LUGANO trial. They are randomized to receive either aflibercept every 8 weeks or EYP-1901 every 6 months, with supplemental aflibercept injections per prespecified criteria.

Click here to learn more about the LUGANO study or to access a full list of Texas Retina’s current clinical trials.

About Wet Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a leading cause of vision loss in people over the age of 50. It happens when the macula, the central part of the retina responsible for detailed vision tasks, is damaged. Wet AMD is an advanced form of the condition where abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially severe vision loss. It is a lifelong disease that requires continuous treatment to maintain visual function.

About Ashkan Abbey, MD
Dr. Abbey cares for patients in Texas Retina’s Dallas Main and Rockwall offices and serves as our Director of Clinical Research for Dallas. You can learn more about him here.