Oculis Holding AG (NASDAQ: OCS, XICE: OCS) announced its Q3 2024 financial results and provided updates on its clinical development programs. The company is advancing its late-stage pipeline, with key milestones expected in the near term. Riad Sherif, M.D., Chief Executive Officer of Oculis, highlighted the progress in the OCS-01 DIAMOND program for diabetic macular edema (DME) and the anticipated topline readout from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON).
Clinical Pipeline Advancements
Oculis has made substantial enrollment progress in its Phase 3 DIAMOND program evaluating OCS-01, a high concentration dexamethasone eye drop, for DME. Approximately 70% of patients are enrolled in the DIAMOND-1 trial and 40% in the DIAMOND-2 trial. OCS-01 aims to address unmet needs in early DME treatment and for patients inadequately controlled with current therapies. David Eichenbaum, M.D., presented an update on the DIAMOND Phase 3 program at Innovate Retina, emphasizing OCS-01's potential as a non-invasive therapy.
The company expects topline data from the Phase 2 ACUITY trial of OCS-05 in AON in December 2024. The trial is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the safety and tolerability of OCS-05. The study has completed enrollment with 36 patients randomized. OCS-05 is a peptidomimetic serum glucocorticoid kinase-2 (SGK-2) activator with potential neuroprotective benefits. AON is a rare inflammatory condition of the optic nerve that can lead to permanent visual impairment, affecting up to 8 in 100,000 people worldwide. Current treatments, like corticosteroids, address inflammation, but therapies that preserve vision or provide neuroprotection are lacking.
Regulatory and Development Plans
Following a pre-NDA meeting with the FDA in August 2024, Oculis plans to be NDA submission ready for OCS-01 in post-operative pain and inflammation in Q1 2025. The company also plans to consult with the FDA in Q1 2025 to discuss the positive topline results from the Phase 2b RELIEF trial and next steps for OCS-02 (licaminlimab) development in dry eye disease (DED). OCS-02 has shown predictive effects in a specific TNFR1 genotype population, suggesting its potential as a precision medicine for DED.
Financial Position
As of September 30, 2024, Oculis reported cash, cash equivalents, and short-term investments of $125.0 million, compared to $109.0 million as of December 31, 2023. The increase reflects proceeds from a registered direct offering in Q2 2024. The company anticipates that its current cash balance will fund operations into the second half of 2026. Research and development expenses for the three months ended September 30, 2024, were $15.0 million, compared to $10.0 million in the same period in 2023, primarily due to higher clinical trial expenses in the ongoing OCS-01 DIAMOND Stage 2 trials and OCS-05 ACUITY trial.
