Global biopharmaceutical company Oculis has announced positive top-line results from its Phase 3 OPTIMIZE trial with OCS-01 eye drops, for the treatment of inflammation and pain following ocular surgery.

OPTIMIZE’s results follow the positive top line results from stage 1 of the Phase 3 DIAMOND trial in diabetic macular oedema reported earlier this year, further highlighting the product’s potential for treating front- and back-of-the-eye diseases.

OCS-01 is a novel, once-daily, high concentration (15mg/ml), preservative-free, topical Optireach formulation of dexamethasone,

In a news release, the company said the Optireach solubilising formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface.1 This, in turn, enables less frequent administration for front-of-the-eye and the drug passage from the eye surface to the posterior segment for back-of-the-eye diseases.

The company said OPTIMIZE is a doubleblind, placebo-controlled Phase 3 trial conducted in 25 sites across the United States with 241 patients randomised 1:1 to receive a once daily (QD) OCS-01 eye drop (n=119) or vehicle (n=122) for 14 days following cataract surgery.

Oculis said the trial met both hierarchical primary efficacy endpoints, the absence of inflammation at day 15, and the absence of pain at day four, with robust statistical significance.

OCS-01 was well-tolerated with a favourable safety profile, Oculis said.

“This is significant for patients who have undergone cataract surgery, as they currently need to self-administer multiple daily doses of eye drops to alleviate inflammation and pain,” said Dr Eric Donnenfeld, co-chair of Oculis’ Scientific Advisory Board.

As well as positive results from the OPTIMIZE and DIAMOND trials, the drug is being investigated as a potential treatment for cystoid macular oedema, one of the most significant causes of vision loss following cataract surgery.

Reference available at mivision.com.au