Duravyu (vorolanib intravitreal insert)

Vorolanib intravitreal insert is investigational and has not been approved by the FDA. EyePoint anticipates a New Drug Application in the first half of 2027, contingent on LUCIA topline results expected in the fourth quarter of 2026. LUGANO did not meet its primary best-corrected visual acuity noninferiority endpoint in the full dataset, so the approved population and label are not yet defined. In the phase 3 trials, the insert (2.7 mg, delivered as 2 inserts in a single injection) was given every 6 months starting at month 2, after aflibercept loading doses, with supplemental aflibercept allowed by prespecified disease-activity criteria. The trials enrolled both treatment-naive participants (75.4% of the LUGANO insert arm) and previously treated participants, who needed at least 2 anti-VEGF injections in the prior 6 months. The phase 2 DAVIO 2 trial enrolled only previously treated participants. Based on these designs, the anticipated use is maintenance therapy after anti-VEGF induction, with rescue anti-VEGF injections as needed, in treatment-naive or previously treated patients. The sponsor expects physicians to incorporate the product into existing treatment approaches. Administration is an office-based intravitreal injection, the same care setting as current anti-VEGF therapy. An independent 2025 review stated that larger controlled trials are needed to define the clinical role of sustained-release tyrosine kinase inhibitors.