EyePoint Pharmaceuticals (EYPT) investor relations material

Program and pipeline updates

• Phase 3 trials for wet AMD (LUGANO and LUCIA) are fully enrolled, with topline data expected mid-2025 to mid-2026; DME phase 3 trials (COMO and CAPRI) will begin dosing between Q1 2025 and Q1 2026, with readouts in Q4 2027.

• DuraCert/Durasert E technology underpins the sustained-release platform, with four prior FDA-approved products and a new high-drug-load insert, Duravyu, in late-stage development.

• Pipeline includes EYP2301 (ResprotaFib/TIE-2 agonist), with Phase 3 FPI anticipated in Q1 2026, expanding future opportunities.

• Commercial scale-up is underway, with a new 41,000 sq ft US-based facility built to FDA/EMA standards, supporting large-scale production and NDA filing.

• Cash reserves of ~$366 million provide operational runway through Q4 2027, covering all ongoing phase 3 trials and key milestones.

Clinical trial design and results

• Wet AMD phase 3 trials are non-inferiority studies against on-label Eylea, with all patients receiving active treatment and low dropout rates.

• DME phase 3 trials will randomize patients to Duravyu or Eylea, with primary endpoints at weeks 52 and 56; Duravyu is dosed on day one to demonstrate early efficacy.

• Phase 2 Verona trial in DME showed Duravyu provided faster and greater early vision gains and OCT improvements compared to Eylea, attributed to IL-6 blockade.

• Over 70% of patients in the high-dose Duravyu arm were rescue-free, with significant anatomical normalization and sustained effects for 24 weeks after a single dose.

• No ocular or systemic serious adverse events or safety signals observed in over 190 patients treated with Duravyu to date.

Mechanism of action and differentiation

• Duravyu (vorolanib) is a multi-MOA TKI that blocks VEGF, PDGF, and all four JAK receptors, especially JAK1, providing anti-inflammatory benefits via IL-6 inhibition.

• Cell-based assays confirmed over 50% reduction in IL-6 activity at clinically relevant doses, outperforming other TKIs.

• The insert's design allows for immediate and sustained drug delivery, with a high drug-to-matrix ratio and no free-floating particles.

• Duravyu's unique MOA may offer anti-fibrotic and neuroprotective effects, potentially differentiating it from current anti-VEGF therapies.

• DURAVYU is the only TKI in development for DME, with a dual mechanism targeting both VEGF and IL-6.