Oculis (OCS) The Baird 2024 Global Healthcare Conference summary

Clinical pipeline overview

• Three clinical-stage assets: OCS-01 (topical for DME, phase III), OCS-02 (TNF inhibitor for dry eye and uveitis), and OCS-05 (neuroprotective agent for acute optic neuritis, data expected soon).

• OCS-01 targets a large unmet need in DME, with potential to treat a market two to three times larger than current standards.

• OCS-02 uses a precision medicine approach in dry eye, leveraging a biomarker present in about 20% of patients.

• OCS-05 aims to reduce retinal ganglion cell death and demyelination, with safety as the primary endpoint in upcoming trials.

• All programs are fully funded with cash runway through end of 2026.

OCS-01 for diabetic macular edema (DME)

• OCS-01 offers topical administration with efficacy comparable to anti-VEGF injections, addressing early intervention and non-responders.

• Phase III trials (Diamond-1 and Diamond-2) are on track, with enrollment and treatment timelines aligning with projections.

• FDA required a vehicle-controlled study; trials are designed to show statistical superiority in BCVA.

• Safety profile shows manageable intraocular pressure increases, mostly reversible and monitorable.

• Commercial strategy targets both first-line and anti-VEGF non-responders, with strong physician interest.

OCS-01 in ocular surgery and CME

• Pre-NDA meeting with FDA confirmed sufficient data for submission in Q1.

• Focused launch planned for patients at risk of retinal complications post-surgery, especially those with diabetes.

• Administrative error in a previous study did not impact safety, timelines, or probability of success.