Oculis advances precision ophthalmology with first patient in dry eye trial

Oculis Holding (NASDAQ:OCS) announced it has randomized the first patient in its PREDICT-1 clinical trial, marking the launch of the first genotype-based registrational study aimed at treating dry eye disease.

The milestone positions the company at the forefront of a shift toward precision medicine within an ophthalmic sector that has historically relied on broad-spectrum therapies.

The FDA-aligned study is evaluating the efficacy and safety of licaminlimab, an innovative topical eye drop engineered to block tumor necrosis factor alpha.

The trial specifically filters and targets patients who carry a distinct TNFR1 genotype.

In previous mid-stage clinical readouts, patients possessing this specific genetic biomarker demonstrated a pronounced, correlated therapeutic response to the active molecule compared to a vehicle control group.

The PREDICT-1 study is designed as a randomized, multi-center, double-masked trial with an expected enrollment of approximately 160 patients.

According to the company's framework, roughly two-thirds of the enrolled participants are projected to carry the targeted TNFR1 genotype, allowing researchers to measure primary symptom relief benchmarks within the biomarker subgroup while simultaneously assessing broader secondary endpoints across the unselected population.

Operational execution is advancing swiftly, with about 70% of the designated U.S. clinical sites already fully activated.

The launch of the registrational trial underscores a commercial push into a highly unsatisfied therapeutic market.

Current estimates indicate that only about 13% of dry eye disease patients in the United States achieve sustained relief from existing prescription or over-the-counter products, which often leads to high treatment discontinuation rates within the first six months.