Advancing DuraVu into Phase 3 across key indications
Pivotal programs progressing: two Phase 3 wet AMD trials (Lugano and LUCIA) ongoing with top-line data expected beginning mid-2026; first patients dosed last week in both pivotal Phase 3 DME trials (COMO and CAPRI) with top-line DME data anticipated in 2027.
Strong Phase 2 efficacy signals and differentiated MOA
Phase 2 data (VERONA, DAVIO-2) showed durable single-dose efficacy, early separation vs aflibercept (as early as week 4: ~4–5 letters better and ~40 microns drier in VERONA), and potential six-month redosing. DuraVu's multi-mechanistic profile inhibits VEGF, PDGF and IL-6 via JAK1 (no Tie2 inhibition), supporting claims of faster onset and potential improved long-term outcomes.
Favorable safety profile across clinical program
No ocular or systemic SAEs attributed to DuraVu across >190 (191) treated patients in one Phase 1 and three Phase 2 trials; overall cataract incidence 5.8% (DAVIO-2 treatment arm ~8% vs EYLEA ~9%), vitreous floaters 5.2%, vitreous opacity ~1% in DAVIO-2, and only two mild cases of iritis (~1%) that resolved with topical therapy.
Commercial and manufacturing readiness
Commercial leadership strengthened with hire of experienced CCO Michael Campbell; 41,000 sq ft cGMP manufacturing facility in Northbridge, MA online >1 year with ~60 full-time employees supporting CMC submission and commercial supply and preparing for pre-approval inspection.
Robust global clinical infrastructure and investigator support
DME programs planned as global studies with ~140 sites across COMO and CAPRI, leveraging the wet AMD network; all invited wet AMD sites agreed to participate in DME studies, indicating investigator confidence and expected rapid enrollment.
Solid near-term capital position to fund operations
Cash and investments of $306 million as of 12/31/2025 (following a $173 million follow-on financing in October 2025) expected to fund operations into 2027 and fully support Phase 3 wet AMD NDA preparation and pivotal DME programs.
Statistically powered trial design with meaningful treatment-burden endpoint
Wet AMD trials use on-label aflibercept controls and noninferiority design; treatment-burden secondary endpoint measured after loading dose (DuraVu mandated 2 injections vs aflibercept 5 in year 1 = theoretical 60% reduction; applying DAVIO-2 supplementation rates implies ~40% reduction). Study is powered to detect treatment-burden differences as small as ~7–10%.