Once-daily administration of an investigational corticosteroid eye drop (OCS-01) was found to reduce inflammation and pain following cataract surgery, according to results from the phase 3 OPTIMIZE trial.
OCS-01 is a high concentration (15mg/mL), preservative-free, topical formulation of dexamethasone. The novel formulation uses a proprietary technology called OPTIREACH®, which allows for less frequent administration of the drug.
The double-blind, placebo-controlled OPTIMIZE trial (ClinicalTrials.gov Identifier: NCT05147233) evaluated the efficacy and safety of OCS-01 in 241 patients 18 years of age and older following cataract surgery. Study participants were randomly assigned 1:1 to receive either OCS-01 or vehicle applied once daily for 14 days. The coprimary endpoints were the proportion of patients with an absence of anterior chamber cells at day 15 and an absence of ocular pain at day 4.
Findings showed that 57.2% of patients treated with OCS-01 had an absence of anterior chamber cells (score ‘0’) at day 15 compared with 24% of those who received vehicle (P <.0001). Additionally, 75.5% of patients treated with OCS-01 had an absence of pain (score of ‘0’) at day 4 vs 52.0% of those in the vehicle group (P <.0001).
OCS-01 was reported to be well tolerated; a greater number of ocular treatment emergent adverse events occurred in the vehicle arm. No meaningful difference in intraocular pressure was noted in either group (mean change from baseline to day 15: -0.90 mmHg in both the OCS-01 and vehicle groups).
“A once daily topical steroid eye drop has shown solid results in reduction of inflammation and pain and offers the potential of a truly simplified dosing regimen,” said Riad Sherif MD, Chief Executive Officer of Oculis. “We are on track to advance OCS-01 for inflammation and pain following ocular surgery towards an NDA submission with FDA.
This article originally appeared on MPR
OCS-01, first investigational eye drop for front and back of the eye, met both primary endpoints in phase 3 OPTIMIZE trial with a once daily regimen for the treatment of inflammation and pain following cataract surgery. News release. Oculis Holding AG. Accessed August 8, 2023. https://www.globenewswire.com/news-release/2023/08/08/2720376/0/en/OCS-01-First-Investigational-Eye-Drop-for-Front-and-Back-of-the-Eye-Met-Both-Primary-Endpoints-in-Phase-3-OPTIMIZE-Trial-with-a-Once-Daily-Regimen-for-the-Treatment-of-Inflammation.html.