Oculis announces positive data from phase 2 trials with novel topical TNF alpha antagonist OCS-02 for DED, acute anterior uveitis

Oculis reported positive data from two of its clinical proof-of-concept phase 2 trials for OCS-02, a novel topical anti-TNF alpha antibody fragment candidate, for the treatment of dry eye disease and acute anterior uveitis.

Presented at the virtual Association for Research and Vision in Ophthalmology (ARVO) 2021 meeting, the data progression illustrates the company’s strong pipeline, according to CEO Riad Sherif, MD.

Dry eye disease
The phase 2, multi-center, randomized, vehicle-controlled, double-masked, prospective study discovered that OCS-02 was significantly more effective than vehicle in relieving severe ocular discomfort associated with DED, according to a company news release.

An analysis indicated a statistically significant association between a genetic biomarker and DED patients’ response to OCS-02, the release stated.

Further investigation will be necessary in order to better understand the role of specific gene variants in DED as well as susceptibility to anti-TNFα therapies.

The correlation found between a genetic variant and improved response to OCS-02 treatment is intriguing, said study author Victor L. Perez, MD, a Stephen and Frances Foster Distinguished Professor of Ocular Immunology and Inflammation, Duke University School of Medicine.

“It could be very helpful in clinical practice to be able to predict response to treatment, especially in dry eye given the heterogeneous population affected by this disease,” he said.

The target of the next clinical study includes validating the role of OCS-02 as a new anti-inflammatory treatment for DED and the biomarker — potentially enabling OCS-02 to become the first personalized treatment in this indication, according to the release.

Uveitis
In the phase 2, multicenter, randomized, parallel-group, double-masked, active-controlled study of acute anterior uveitis-diagnosed patients, application of OCS-02 indicated efficiency — in alignment with pre-specified criteria — in treating ocular inflammation, the release stated. No steroid-type side effects or eye irritation were reported.

“There is a clear unmet medical need for non-steroidal anti-inflammatory therapies for uveitis,” said study author Anat Galor, MD, Professor of Ophthalmology, University of Miami Health System, in a statement. “This is particularly important for patients who require longer-term anti-inflammatory treatment, given that long-term steroid treatment is not optimal due to the associated side effect profile.