Oculis moves closer to securing approval for innovative eye drops

Oculis has completed patient enrollment for its Phase 3 study on OCS-01 eye drops. This brings the innovative active substance a step closer to being approved, further details of which can be found in a press release issued by the Zug-based biopharmaceutical firm. According to the press release, if approved OCS-01 would become the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.

According to Oculis, the Phase 3 study that is about to commence will be carried out in the USA at 25 different locations. A total of 240 subjects have been enrolled for this randomized, double-blind, placebo-controlled series of trials that will aim to verify the efficacy and safety of OCS-01. Efficacy measures include an absence of inflammation at day 15 and zero pain by the fourth day.

This could result in a “significant therapeutic benefit”, comments Eric Donnenfeld, co-chair of the Scientific Advisory Board at Oculis, in the press release. “In addition, given its ability to reach the back of the eye, it could also offer further benefit in treating retinal edema”, he adds. A Phase 2 trial and an exploratory study have already shown initial indications of this. The company expects results in the course of this year from the first phase of the corresponding EU-funded DIAMOND study. mm