ASRS 2026: DAVIO 2 post hoc analysis shows stable vision and anatomy with EYP-1901 in patients meeting phase 3 criteria

A post hoc analysis of the phase 2 DAVIO 2 trial (NCT05381948) applied the inclusion criteria of the ongoing phase 3 LUGANO (NCT06668064) and LUCIA (NCT06683742) trials to the phase 2 population and found stable vision and anatomic outcomes with EYP-1901 (vorolanib intravitreal insert; EyePoint Pharmaceuticals). Aleksandra Rachitskaya, MD, FASRS, reported the findings at the American Society of Retina Specialists (ASRS) 44th Annual Meeting in Montréal, Québec, Canada.

How does EYP-1901 differ from current anti-VEGF injections?

EYP-1901 is a bioerodible intravitreal insert that provides sustained release of vorolanib—a multitarget tyrosine kinase inhibitor (TKI)—for at least 6 months. Rachitskaya emphasized the mechanistic contrast with existing therapy: vorolanib acts intracellularly to inhibit VEGF receptors 1-3, platelet-derived growth factor receptor, and IL-6 signaling, whereas standard anti-VEGF agents suppress VEGF extracellularly.¹

Why revisit the DAVIO 2 population through a phase 3 lens?

DAVIO 2 evaluated a single dose of EYP-1901 (2 mg or 3 mg) against on-label aflibercept (Eylea; Regeneron) 2 mg every 8 weeks in patients with previously treated wet age-related macular degeneration (wet AMD). Because the trial produced a robust data set, the investigators applied the LUGANO and LUCIA eligibility criteria to the DAVIO 2 cohort to contextualize potential phase 3 outcomes. Of 156 enrolled patients, 92 met the best-corrected visual acuity (BCVA) inclusion criterion for the phase 3 trials.

What did the analysis show on vision and anatomy?

BCVA remained stable through month 8—6 months after EYP-1901 administration—in both the full population and the phase 3 subgroup. In the subgroup, the month 7/8 blended least-squares mean BCVA change from baseline measured +1.5 letters with EYP-1901 2 mg, +1.6 letters with EYP-1901 3 mg, and +2.6 letters with aflibercept. Mean central subfield thickness changes in the subgroup measured +18.0 µm, +8.9 µm, and +0.8 µm, respectively. Applying the phase 3 supplemental treatment criteria reduced the proportion of patients meeting criteria compared with the phase 2 criteria—for example, 13.5% vs 36.5% with EYP-1901 3 mg.¹

Rachitskaya framed durability as the central unmet need. "Potentially providing the sustained release will allow us to give durability and support the visual outcomes for our patients," she told Modern Retina. She cautioned that the analysis cannot predict phase 3 results, noting it remains impossible to say exactly what those trials will show. EYP-1901 was generally well tolerated, with no safety signals reported. LUGANO topline results are expected in late 2026, with LUCIA anticipated shortly after.

Reference
1. Rachitskaya A, Ribeiro R. DAVIO 2 phase 2 trial of bioerodible EYP-1901 (vorolanib intravitreal insert) in wet AMD: post hoc analysis in patients who met phase 3 trial criteria. Presented at: American Society of Retina Specialists 44th Annual Meeting; July 15-18, 2026; Montréal, Québec, Canada. POD 1: AMD—Neovascular.