Oculis (OCS) 25th Annual Needham Virtual Healthcare Conference summary

Strategic overview and pipeline highlights

• Three late-stage assets target a combined market opportunity exceeding $25 billion, including OCS-01 for diabetic macular edema (DME), licaminlimab for dry eye disease, and privosegtor for neuro-ophthalmology indications.

• OCS-01 is a non-invasive eye drop for DME, positioned for both untreated and inadequately controlled patients, with phase III top-line results expected in June and potential NDA submission in Q4.

• Licaminlimab uses a genotype-based approach for dry eye disease, with phase II trials showing strong efficacy in TNFR1-positive patients; phase III (PREDICT-1) readout is anticipated by late 2026.

• Privosegtor, a neuroprotective agent, is in registrational trials for optic neuritis and NAION, with FDA Breakthrough Therapy and EMA PRIME designations; top-line results from PIONEER-1 expected in 2027.

• Strong financial position with no debt and cash runway into 2029, excluding a CHF 100 million loan facility.

Clinical development and market positioning

• OCS-01 demonstrated superior efficacy to Ozurdex in phase III stage I, with over 27% of patients gaining more than 15 letters at week 12; aims to address both early intervention and inadequately controlled segments.

• Licaminlimab targets the 20% of U.S. dry eye patients with the TNFR1 genotype, offering a precision medicine approach and potentially first-line treatment for this subgroup.

• Privosegtor’s ACUITY phase II trial showed significant functional and anatomical benefits in optic neuritis, with no adverse events leading to discontinuation.

• Regulatory interactions have been positive, with supportive feedback from the FDA on trial designs and endpoints, facilitating efficient development pathways.

• Commercial strategy for OCS-01 focuses on expanding the DME market by addressing untreated patients and supplementing current therapies, rather than displacing anti-VEGF treatments.

Upcoming milestones and outlook

• OCS-01 phase III DIAMOND program readout expected in June, with NDA submission planned for Q4 and potential approval in Q4 next year.

• Licaminlimab PREDICT-1 phase III trial ongoing, with results anticipated by end of 2026.

• Privosegtor’s PIONEER-1 trial underway, with top-line results expected in 2027; additional trials for NAION and optic neuritis to commence later this year.

• Breakthrough Therapy and PRIME designations for privosegtor enable frequent regulatory dialogue and may accelerate approval timelines.

• Multiple registrational trial readouts are expected from 2024 through 2027, supporting a catalyst-rich period for the company.