AAO 2025: The outcomes of the VERONA and DAVIO-2 studies set up continued phase 3 research

Ashkan Abbey, MD, FASRS, FAAO, from Texas Retina Associates discussed EYP-1901, an innovative intravitreal insert that releases vorolanib, a potent tyrosine kinase inhibitor designed to treat retinal vascular diseases, specifically wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The conversation highlighted 2 phase 2 clinical trials: DAVIO-2 for wet AMD and VERONA for DME. In the DAVIO-2 trial, patients previously treated with approximately 10 injections in the prior year received 3 loading doses of aflibercept, followed by either high-dose or low-dose EYP-1901 or a sham treatment. The results were promising:

• 85% reduction in treatment burden
• Two-thirds of patients did not require additional treatments
• Non-inferiority in best-corrected visual acuity at 6 months

The VERONA trial for DME involved patients receiving a single injection of EYP-1901 or aflibercept. Key findings included:

• Significantly increased time to supplemental injection
• Substantial improvement in visual acuity and anatomy
• Two-thirds of EYP-1901 patients did not require additional injections, compared to only half in the aflibercept group

The medication's unique mechanism targets all 3 VEGF receptors while preserving the tie2 pathway, potentially promoting vascular stability. Safety data has been encouraging, with no significant safety signals observed across nearly 200 patients. Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD have been fully enrolled, with data expected in the next year. A potential FDA submission may follow.

Abbey emphasized the critical need for more durable treatment options to reduce the treatment burden on both patients and healthcare providers. The potential of EYP-1901 to provide sustained treatment with potentially fewer injections represents a significant advancement in managing retinal vascular diseases. The conversation concluded with optimism about the potential game-changing nature of this new treatment approach, pending the results of ongoing phase 3 trials.