Oculis Begins Phase 3 OPTIMIZE-2 Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery

Oculis Holding announced 'First Patient First Visit' (FPFV) in the OCS-01 phase 3 OPTIMIZE-2 trial for the treatment of inflammation and pain following cataract surgery. Data from the phase 3 OPTIMIZE-2 trial is intended to support the company’s NDA submission to the FDA. If approved, OCS-01 has the potential to be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.

OPTIMIZE-2 is a multicenter, randomized, double-masked, vehicle-controlled phase 3 trial evaluating OCS-01 for the treatment of inflammation and pain following cataract surgery. Similar to the OPTIMIZE-1 trial, patients in the second phase 3 OPTIMIZE-2 trial will be treated with once-daily OCS-01 post-cataract surgery versus vehicle for 2 weeks. Primary endpoints are the absence of anterior chamber cells (inflammation) on Day 15 and absence of pain on Day 4. The OPTIMIZE-2 trial follows the positive topline results from the OPTIMIZE-1 trial showing that OCS-01 increased the percentage of patients who were inflammation free at Day 15 and had zero pain at Day 4 vs. vehicle with statistical significance (P<0.0001 for both endpoints), and was well tolerated.

Moreover, the initiation of OPTIMIZE-2 follows the start of Stage 2 of the phase 3 DIAMOND trial of OCS-01 in DME announced earlier this week, and the commencement of the investigator-initiated LEOPARD trial of OCS-01 in patients with CME announced 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.”