Oculis Initiates Phase 3 Trial for OCS-01 to Treat Inflammation and Pain Post-Cataract Surgery

Oculis announced the commencement of the 'First Patient First Visit' (FPFV) in the OCS-01 phase 3 OPTIMIZE-2 trial for treating inflammation and pain following cataract surgery. The data from OPTIMIZE-2 is crucial to support the company's New Drug Application (NDA) submission to the FDA.

If approved, OCS-01 could potentially become the first once-daily, topical, preservative-free corticosteroid for addressing inflammation and pain after ocular surgery.

The OPTIMIZE-2 trial is a multicenter, randomized, double-masked, vehicle-controlled phase 3 study assessing OCS-01's effectiveness in treating inflammation and pain post-cataract surgery. Similar to OPTIMIZE-1, patients in OPTIMIZE-2 will receive once-daily OCS-01 or vehicle for 2 weeks after cataract surgery.

Primary endpoints include the absence of anterior chamber cells (indicating inflammation) on Day 15 and the absence of pain on Day 4. This trial builds on the positive topline results from OPTIMIZE-1, where OCS-01 demonstrated statistical significance (P<0.0001) in increasing the percentage of patients with no inflammation on Day 15 and zero pain on Day 4 compared to the vehicle and was well-tolerated.

Furthermore, the initiation of OPTIMIZE-2 follows the launch of Stage 2 of the phase 3 DIAMOND trial of OCS-01 in DME earlier this week and the initiation of the investigator-initiated LEOPARD trial of OCS-01 in patients with CME earlier this year.

“Initiation of the OPTIMIZE-2 trial preceded by the launch of OCS-02 RELIEF phase 2b trial in dry eye, and OCS-01 DIAMOND-1 trial in DME in the past couple weeks, highlights our robust pipeline and ability to execute and deliver on commitments," Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. "This timely progress also underscores the steadfast advancement of the OCS-01 development program thus far, as well as OCS-01’s potential as an eye drop treatment for both front- and back-of-the-eye diseases. We look forward to the important milestones expected in the year ahead, including four topline clinical readouts from OPTIMIZE-2 and the LEOPARD trials with OCS-01, the RELIEF trial with OCS-02, and from the ACUITY trial in Acute Optic Neuritis (AON) with OCS-05.”