Oculis (OCS) R&D Day 2025 summary

Strategic pipeline and portfolio focus

• Three lead assets prioritized: OCS-01 for diabetic macular edema (DME), Licaminlimab (OCS-02) for dry eye disease, and Privosegtor (OCS-05) for neuroprotection in acute optic neuritis, with expansion into NAION and MS relapses.

• Portfolio prioritization centers on high-value, high-unmet-need indications, with resource allocation shifted from ocular surgery to DME and neuroprotection.

• Recent $100 million capital raise in an oversubscribed equity financing supports accelerated development and execution of these programs.

• Strategic evolution aims to advance, expand, and explore new indications for Privosegtor in neuro-ophthalmology and neurology.

OCS-01 (DME) clinical and commercial update

• Phase III DIAMOND 1 and 2 trials fully enrolled (>800 patients), with top-line results expected in Q2 2026.

• OCS-01 is positioned as the first topical treatment for DME, targeting early intervention and patients unresponsive to anti-VEGF therapies.

• Previous studies showed robust, statistically significant improvements in vision and retinal edema reduction.

• Trials are randomized, double-blind, placebo-controlled, with primary endpoint of BCVA letter score change at 52 weeks.

• Commercial strategy anticipates a paradigm shift, enabling earlier treatment by general ophthalmologists and optometrists, expanding both patient and prescriber pools.

Licaminlimab (OCS-02) precision medicine approach

• Genotype-based development for dry eye disease, focusing on TNFR1-positive patients (~20% prevalence), with rapid, meaningful efficacy and high tolerability.

• FDA agreement on registrational trial design, with primary endpoint in genotype-positive population and efficient enrollment strategy.

• High discontinuation rates with current DED therapies highlight significant unmet need for personalized medicine.

• Phase 2/3 study will focus on TNFR1 genotype-positive patients, with global ocular discomfort as the primary endpoint.

• Registration program to start in 2H 2025.