Investigators share positive results of DAVIO 2 trial at EURETINA 2025

(Image credit: AdobeStock/THANANIT)

EYP-1901, known as the vorolanib intravitreal insert, was highlighted at the EURETINA 2025 meeting, which was held in Paris, France. In 2 presentations, researchers shared the recent results from the DAVIO 2 clinical trial.

What is EYP-1901?

EYP-1901 is a bioerodible, sustained-release intravitreal insert that delivers vorolanib, a potent and selective tyrosine kinase inhibitor that works intracellularly to provide pan-VEGF receptor inhibition, for at least 6 months.¹

What is the DAVIO 2 trial?

DAVIO 2 (NCT05381948) was a phase 2, multicenter, controlled, prospective, randomized, double-masked study in patients with previously treated neovascular age-related macular degeneration (nAMD), conducted at 67 study locations in the United States. This trial assessed efficacy and safety of 1 intravitreal injection of EYP-1901 compared to intravitreal injections of aflibercept 2mg every 8 weeks in previously-treated eyes with nAMD.¹

The primary endpoint was mean change in BCVA from Day 1 to Week 28/32, averaged. Secondary endpoints included safety, mean change in central subfield thickness (CST), proportion of eyes without supplemental injections, and BCVA through 56 weeks.¹

What were the vision outcomes of DAVIO 2?

The results of this trial showed that 156 eyes were evaluated. The primary endpoint of the trial was met with the mean BCVA change from baseline at the average of Month 7/8 for EYP-1901 2mg and 3mg was statistically noninferior to aflibercept. EYP-1901 maintained or improved vision in >80% of patients. EYP-1901was well-tolerated, with no EYP-1901-related ocular or systemic serious adverse events.¹

With these outcomes in mind, the researchers concluded that in the DAVIO 2 trial, a single dose of EYP-1901 resulted in similar proportions of eyes with improvements in visual acuity as aflibercept q8W over 6 months with vision maintained or improved in over 80% of patients. At the 2025 EURETINA meeting, the presenters also noted that global pivotal phase 3 trials LUGANO (NCT06668064) and LUCIA (NCT06683742) for nAMD are assessing EYP-1901 with redosing at 6-month intervals.¹

What did researchers learn about the potential to reduce treatment burden?

Along with the visual outcomes of the DAVIO 2 trial, researchers also presented on the reduction in treatment burden

Patients in the trial were previously-treated nAMD and were randomized to receive aflibercept 2mg monthly for 3 loading doses followed by either aflibercept 2mg q8W, or one injection of EYP-1901 2mg or EYP-1901 3mg. Patients were assessed for SAIs at each visit, using prespecified best-corrected visual acuity (BCVA) and anatomic criteria; supplementation per investigator discretion was permitted.²

Patients received mean 0.55 and 0.73 SAIs/6 months with EYP-1901 2mg and 3mg (Weeks 8-32) respectively. This represents an 88%,85% treatment burden reduction from pre-trial. Overall, 63% of EYP-1901-treated eyes did not require a SAI up to Week 32. The primary endpoint was met. BCVA and CST were maintained on average throughout the trial in all arms.²

The based on the results of the trial, researchers concluded that 1 dose of EYP-1901 with protocol-specified supplementation substantially reduced treatment burden in patients.²

References:

1. Sivaprasad, S. Lim, JL. Ribeiro, R. DAVIO 2 Phase 2 Clinical Trial Results: Vision Outcomes with EYP-1901(Vorolanib Intravitreal Insert) Versus Aflibercept in Previously-Treated Neovascular Age-Related Macular Degeneration. Abstract. 25^th EURETINA Congress. September 4-7, 2025. Paris, France.

2. Dinah, C. Ribeiro, R. DAVIO 2 Phase 2 Clinical Trial Results: Treatment Burden in Neovascular Age-related Macular Degeneration Treated with EYP-1901 (Vorolanib Intravitreal Insert) Versus Aflibercept. Abstract. 25^th EURETINA Congress. September 4-7, 2025. Paris, France.