OR WAIT null SECS
Positive topline results from the phase 3 trial suggest once-daily OCS-01 met both primary trial endpoints for the treatment of inflammation and pain following cataract surgery.
Positive topline results indicate once-daily OCS-01 eye drops met both primary endpoints in the phase 3 OPTIMIZE trial, demonstrating a superior reduction in inflammation and pain following cataract surgery compared to vehicle.1
Announced by Oculis, the data follow positive and statistically significant topline results reported from stage 1 of the phase 3 DIAMOND trial in eyes with diabetic macular edema (DME), indicating the potential of OCS-01 for treating both front- and back-of-the-eye diseases.
“The results of the phase 3 OPTIMIZE trial are exciting because once-daily OCS-01 showed to be superior and highly potent in reducing inflammation and pain compared to vehicle with a favorable safety profile,” Erick Donnenfeld, MD, co-chair of the Oculis Scientific Advisory Board, said in a statement. “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.”
Due to an aging population, ophthalmic surgical procedures are expected to reach almost 10 million procedures per year in the US in the next 2 decades. Although cataract surgery creates a small incision, it can lead to inflammation in the cornea, anterior chamber, and iris, requiring topical steroids. Often, patients are required to self-administer multiple drops daily, which has been linked to compliance issues.
Utilizing the company’s OPTIREACH® solubilizing formulation technology, OCS-01 is a novel, high-concentration (15 mg/ml), preservative-free, topical formulation of dexamethasone indicated for the treatment of inflammation and pain following ocular surgery. The OPTIMIZE trial is a double-blind, placebo-controlled, phase 3 trial performed in 25 sites across the United States. A total of 241 patients were randomized in a 1:1 ratio to receive once-daily OCS-01 eye drops (n = 119) or vehicle (n = 122) for 2 weeks following cataract surgery.
Both hierarchical primary efficacy endpoints were met, including the absence of inflammation at Day 15 and the absence of pain at Day 4, with robust statistical significance.
The inflammation endpoint showed the percentage of eyes with zero inflammation was statistically significantly greater with once-daily OCS-01 compared with vehicle at Day 15 (57.2% vs. 24.0%; P <.0001). For pain, the analysis reported a statistically significantly greater percentage of eyes with zero pain were treated with OCS-01 compared with vehicle at Day 4 (75.5% vs. 52.0%; P <.001).
Safety analyses showed OCS-01 was well-tolerated and had a favorable profile. A higher number of ocular treatment-emergent adverse events were reported in the vehicle group (n = 84) compared with the once-daily OCS-01 group (n = 37). The release noted a lack of meaningful difference was observed in intraocular pressure between treatment groups, with a mean change from baseline to Day 15 of -0.90 mmHg in both groups.
Results from OPTIMIZE were consistent with observations from the phase 2 SKYGGN trial with once-daily administration of OCS-01 eye drops. In the phase 2 trial, OCS-01 met the same hierarchical primary efficacy endpoints with robust statistical significance and similar numerical values.2
In the phase 3 DIAMOND trial of DME eyes, positive topline results indicate the OCS-01 arm met its primary efficacy endpoint of mean change in visual acuity versus baseline, with a statistically significant improvement compared to the vehicle arm.3
The release noted the company is now on track to advance OCS-01 for inflammation and pain following ocular surgery toward a New Drug Application with the US Food and Drug Administration (FDA).
“We now have positive phase 3 topline results with OCS-01 preservative-free eye drops in treating front-of-the-eye inflammation and pain following ocular surgery, as well as Stage 1 phase 3 results for back-of-the-eye DME from the DIAMOND program, opening for the first time ever new opportunities for topical eye drops to address highly unmet patient needs in both front- and back-of-the-eye indications,” Riad Sherif, MD, chief executive officer of Oculis, said in a statement.