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Oculis Holding's Q4 Net Loss Narrows; Plans Phase 3 Trial Readouts For OCS-01 In Q2,2026

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Oculis Holding AG (OCS), a clinical-stage ophthalmology-based biopharmaceutical company, announced fourth-quarter and full-year financial results. In addition, it also provided details on upcoming clinical trial readout milestones for its investigational pipeline.

Net loss for the fourth quarter narrowed to 23.51 million Swiss Francs or 0.42 Franc per share, from 28.66 million Francs or 0.67 Franc per share in the prior year.

For the full year 2025, net loss expanded to 98.96 million Francs, or 1.89 Franc per share, from 85.78 million Francs, or 2.12 Franc per share, in the year ago. In terms of US dollars, this amounts to a net loss of $119.1 million in 2025, compared to $97.4 million in 2024.

As of December 31, 2025, the firm reported having cash, cash equivalents, and short-term investments of $268.7 million or 213.0 million Francs compared to $109.0 million or 98.7 million Francs in the prior year, providing a cash runway into 2029.

" The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, to redefine the standard of care in ophthalmology and neuro-ophthalmology," said Riad Sherif, M.D., Chief Executive Officer of Oculis.

Pipeline and Milestones Ahead

The firm's investigational pipeline includes OCS-01 for Diabetic Macular Edema(DME) in Phase 3 trials, Privosegtor for optic Neuritis(ON) and Non-Arteritic Anterior Ischemic Optic Neuropathy(NAION) in Phase 2 trials, and Licaminlimab for Dry Eye Disease(DE) in Phase 2 trials.

OCS-01

The company's lead product candidate, OCS-01, is a topical dexamethasone ophthalmic formulation in Phase 3 clinical trials, DIAMOND1 and DIAMOND 2, for the treatment of DME.

Both the Phase 3 DIAMOND trials with OCS-01 have enrolled over 800 patients and are nearing completion.

The trial readouts from Phase 3 trials with OCS-01 are expected in Q2 2026. If positive, a subsequent NDA submission to the FDA is planned for Q4 2026.

While the US DME market is currently valued at approximately $3 billion, only a fraction of the 1.8 million people diagnosed with the disease are successfully managed according to the firm.

Privosegtor

Privosegtor, is a neuroprotective candidate of Oculis intended for the treatment of optic neuropathies like optic neuritis and non-arteritic anterior ischemic optic neuropathy.

Recently, Oculis' Privosegtor received Breakthrough Therapy designation based on the Phase 2 ACUITY results in optic neuritis. This sight-threatening neuro-ophthalmic condition is often the first clinical manifestation of multiple sclerosis.

In the Phase 2 ACUITY trial results, Privosegtor + steroid showed substantial improvements in vision and consistent anatomical and biological neuroprotective benefits compared with placebo + steroid.

In continuation of that, after a successful meeting with the FDA in the fall of 2025, Oculis launched the PIONEER program, which includes three pivotal trials in optic neuritis and non-arteritic anterior ischemic optic neuropathy.

The first registrational trial in the program, PIONEER-1 in ON, was initiated in Q4 of 2025, with clinical sites activation progressing as planned.

PIONEER's registrational program in optic neuropathies is estimated to have a potential US market opportunity of over $7 billion, according to Oculis.

Licaminlimab

Licaminlimab, is a topical anti-TNFa which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED).

Oculis recently initiated the first genotype-based registrational trial, PREDICT-1, to drive precision medicine in dry eye disease (DED) with Licaminlimab.

In Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from 5-fold greater in signs to 7-fold greater in symptoms according to the firm.

The PREDICT-1 trial results for Licaminlimab, with a precision medicine approach in dry eye disease, are planned for Q4,2026.

OCS has traded between $14.00 and $30.68 in the last year.
The stock closed Tuesday's trade at $27.57, down 3.64%.

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