Global biopharmaceutical firm Oculis has completed participant enrolment in its Phase III Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops (OPTIMIZE) trial of OCS-01 to treat inflammation and pain after cataract surgery.
The placebo-controlled, double-blind, randomised OPTIMIZE trial has been designed for assessing the safety and efficacy of once-daily doses OCS-01.
A total of 240 participants were enrolled in 25 participating sites across the US.
Absence of pain at day four and absence of inflammation at day 15 are some of the trial’s efficacy measures.
Developed using Oculis’ OPTIREACH technology, OCS-01 is a new, preservative-free, high concentration, topical OPTIREACH formulation of dexamethasone.
It met the primary and secondary endpoints of absence of pain and absence of anterior chamber cells and achieved statistical significance for patients treated with OCS-01 in the Phase II SKYGGN trial.
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OCS-01 was also found to be well tolerated in the trial.
Oculis Scientific Advisory Board co-chair Eric Donnenfeld said: “OCS-01 could bring significant therapeutic benefit as a once-daily treatment for inflammation and pain following ocular surgery.
“In addition, given its ability to reach the back of the eye, it could also offer further benefit in treating retinal oedema, as shown in Oculis’ DME Phase II trial and previous exploratory trial in CME, a significant complication following ocular surgery.”
Currently, OCS-01 is also being assessed as the first potential topical treatment for diabetic macular oedema (DME) in another ongoing Phase III DIAMOND clinical trial.
Oculis CEO Riad Sherif said: “Oculis has taken a material step forward in advancing OCS-01’s Phase III clinical trial and I wish to congratulate everyone involved.”