At the 2024 meeting of the American Society of Retina Specialists in Stockholm, Veeral S. Sheth, MD, MBA, FASRS, FACS, presented late-breaking data on supplemental injection in the DAVIO 2 trial of Duravyu (EYP-1901; EyePoint Pharmaceuticals). DAVIO 2 is a phase 2 randomized, prospective clinical trial comparing a single injection of Duravyu at 2 doses vs aflibercept (Eylea; Regeneron) in patients receiving a mean 10 anti-VEGF injections per year for wet AMD.
There were 4 criteria for patients receiving supplemental injection: BCVA reduction of 5 letters from best on study and CST increase of 75 μm from lowest on study, BCVA reduction of 10 letters or more, CST increase of 100 μm or more, or vision-threatening hemorrhage. Two-thirds of patients remained supplemental injection free over 32 weeks, and 6% of patients in the aflibercept group received supplemental injection, indicating the patients were a high treatment need group. Most patients receiving supplemental injection received 1 injection, and most of the supplemental injections were given because of the BCVA plus CST criteria.
"The DAVIO 2 trial, the largest intravitreal tyrosine kinase inhibitor trial to date, showed that Duravyu maintained stable visual acuity and strong anatomic control over 32 weeks,” Dr. Sheth told Retinal Physician. “Remarkably, two-thirds of eyes remained supplement free during this period. These results indicate that EYP-1901 offers good durability and reduces treatment burden, even in patients with high treatment needs." Dr. Sheth also noted during panel discussion that 6 months could be the minimum treatment duration of Duravyu, but that duration will likely be patient specific.
Duravyu is being developed for patients with VEGF-mediated retinal diseases. 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. Vorolanib blocks all VEGF isoforms. Phase 3 study is planned to begin in the second half of 2024.
