Conclusions
1 evidence topic · 13 sources
Summary
- Status: the vorolanib intravitreal insert 2.7 mg (DURAVYU, EYP-1901) is investigational and not approved by the FDA. No price, labeled indication, or labeled dosing exists. EyePoint plans an NDA submission in the first half of 2027, provided that results of the second phase 3 trial (LUCIA), expected in the fourth quarter of 2026, are positive.
- Current care: approved anti-VEGF agents are given by in-office intravitreal injection every 4 to 16 weeks, or every 20 weeks for aflibercept 8 mg after 1 year of successful response, with ongoing monitoring. Real-world visual gains are smaller than in trials, 11.6% of treated participants in the IRIS Registry were lost to follow-up within 12 months, and 2024 Medicare Part B spending on aflibercept 2 mg, aflibercept 8 mg, and faricimab totaled $4.95 billion across all indications.
- Efficacy: in LUGANO (432 participants), the insert did not meet its primary non-inferiority endpoint for BCVA change versus aflibercept 2 mg every 8 weeks in the full dataset. Non-inferiority was shown only in an ad hoc analysis that excluded 9 of 211 insert participants. The sponsor reported a 42% reduction in treatment burden (a mean of 3.1 compared with 5.3 injections after loading through week 56). In the phase 2 DAVIO 2 trial, single insert doses met non-inferiority for BCVA at weeks 28 and 32 in previously treated participants.
- Safety: in LUGANO, conjunctival hemorrhage, vitreous floaters, retinal hemorrhage, and neovascular AMD adverse events were more frequent with the insert, while intraocular inflammation and retinal detachment each occurred in 0.5% of both arms; serious and systemic adverse event data have not been released. In the DAVIO 2 registry results, the 3,090 µg arm had higher rates of study eye visual acuity reduced, vitreous floaters, serious endophthalmitis, and systemic hypertension than the aflibercept arm.
- Evidence limitations: LUGANO results are preliminary sponsor reports without peer review; the comparator was fixed aflibercept 2 mg every 8 weeks rather than aflibercept 8 mg, faricimab, or treat-and-extend dosing; all 76 registered LUGANO sites were in the United States; and no patient-reported outcome data have been released.
- Economic information: no budget impact model, cost-effectiveness analysis, or health technology assessment of the insert has been published. Budget impact will depend on the insert's price relative to the anti-VEGF injections it replaces and on the number of injections avoided.
- Pending information: LUCIA topline results (fourth quarter of 2026), LUGANO subgroup analyses at retina meetings beginning in September 2026, the final LUGANO analysis, and FDA review.