Oculis Holding AG announced its Q3 2024 financial results and provided updates on its clinical development programs. The company is advancing its pipeline, including OCS-01 for diabetic macular edema (DME) and post-operative pain, and OCS-05 for acute optic neuritis (AON). Topline results from the Phase 2 ACUITY trial of OCS-05 in AON are expected in December 2024.
Clinical Program Updates
OCS-01 (Dexamethasone Eye Drop)
Oculis is conducting the Phase 3 DIAMOND program for OCS-01 in DME. Enrollment is progressing, with approximately 70% of patients enrolled in the DIAMOND-1 trial and 40% in the DIAMOND-2 trial as of early October. OCS-01 is a high-concentration dexamethasone eye drop formulated with OPTIREACH® technology. David Eichenbaum, M.D., presented data at Innovate Retina, highlighting OCS-01's potential as a non-invasive therapy for DME, addressing unmet needs for early intervention and patients inadequately controlled with current treatments.
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.
OCS-02 (Licaminlimab)
Oculis is planning 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. OCS-02 is a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis. If approved, OCS-02 (licaminlimab) has the potential to be the first precision medicine for DED given the predictive and more pronounced effects observed in a specific TNFR1 genotype population.
OCS-05 (SGK-2 Activator)
The Phase 2 ACUITY trial of OCS-05 in AON is on track for a topline readout in December 2024. OCS-05 is a peptidomimetic serum glucocorticoid kinase-2 (SGK-2) activator with a novel mechanism of action, potentially offering neuroprotective benefits for neuro-ophthalmic diseases. The ACUITY trial is a randomized, double-blind, placebo-controlled, multi-center trial in France, evaluating the safety and tolerability of OCS-05 in 36 patients. The primary endpoint is safety, with exploratory measurements to assess neuroprotective effects.
AON is a rare inflammatory condition of the optic nerve, affecting up to 8 in 100,000 people worldwide, often leading to permanent visual impairment. While corticosteroids are used to treat the inflammation, there remains a critical unmet medical need for therapies that preserve vision or provide neuroprotection.
Preclinical studies have shown OCS-05 to have neuroprotective activity, preventing retinal ganglion cell damage in glaucoma and AON models, and promoting axonal sparing and reducing demyelination in AON models. A Phase 1 trial in healthy volunteers showed no drug-related side effects.
Financial Highlights
As of September 30, 2024, Oculis had $125.0 million in cash, cash equivalents, and short-term investments, compared to $109.0 million as of December 31, 2023. This increase reflects proceeds from a registered direct offering in Q2 2024. The company expects its cash balance to fund operations into the second half of 2026.
Research and development expenses for Q3 2024 were $15.0 million, compared to $10.0 million in the same period in 2023, primarily due to increased clinical trial expenses for the OCS-01 DIAMOND Stage 2 and OCS-05 ACUITY trials.
Management Commentary
Riad Sherif M.D., Chief Executive Officer of Oculis, stated, "During the quarter, we achieved excellent momentum in product pipeline development... Looking ahead, we are excited for the upcoming topline readout from the OCS-05 Phase 2 ACUITY trial in AON, anticipated in December 2024. The results will provide us with meaningful insights about the safety and tolerability of OCS-05, and its potential as a neuroprotective candidate in acute optic neuritis and other neuro-ophthalmic diseases."
