Imminent Phase III Wet AMD Readouts
Top-line data for pivotal Phase III LUGANO expected mid-year 2026 with LUCIA to follow shortly thereafter; company positions DURAVYU to potentially be first-to-market among sustained-release programs.
Strong DME Phase III Enrollment Momentum
Phase III DME trials (COMO and CAPRI) initiated end of February 2026 with over one-third (>33%) of patients enrolled across both trials and an ambitious goal of full enrollment in Q3 2026; top-line DME data expected H2 2027.
Robust Phase II Clinical Evidence and Durable Efficacy
Across >190 patients in 4 completed trials, DURAVYU showed durable efficacy and a favorable safety profile; VERONA Phase II demonstrated ~4–5 letters vision improvement and ~50-micron anatomic improvement versus aflibercept at week 4.
Favorable Safety/Low Discontinuation Rate
Low discontinuation rate of about 5% in LUGANO/LUCIA (well below the ~10% yearly average in wet AMD trials); masked safety reviews to date show no new safety signals and two consecutive positive DSMC recommendations with a third review scheduled.
Differentiated Multi-Mechanism of Action (MOA)
Preclinical and ARVO-presented data indicate vorolanib (DURAVYU active) inhibits VEGF, PDGF and demonstrates JAK1-mediated IL-6 signaling inhibition, supporting potential anti-inflammatory synergy and clinical differentiation versus current anti-VEGF biologics.
Commercial and Manufacturing Readiness
cGMP Northbridge manufacturing facility online for >1 year supporting anticipated CMC/NDA submission and potential commercial supply; added Chief Commercial Officer and expanded commercial/regulatory teams; product can be shipped/stored at ambient temperature and administered via standard in-office intravitreal injection.
Adequate Near-Term Liquidity to Reach Major Milestones
Cash, cash equivalents and marketable securities totaled $223.0 million as of March 31, 2026; company expects current cash to fund operations into Q4 2027 and through key Phase III wet AMD milestones.