Oculis Holding AG announced First Patient First Visit (FPFV) in 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 Food and Drug Administration (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.
The OPTIMIZE-2 (Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) is a multi-center, randomized, double-masked, vehicle-controlled p 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.
Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “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. 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.”
Eric Donnenfeld, MD, clinical professor of Ophthalmology at New York University and Co-chair of Oculis Scientific Advisory Board, said: “I was excited to see the positive efficacy results and the favorable safety profile from the first phase 3 OPTIMIZE trial and the consistency with the prior phase 2 results. Once daily OCS-01 could become an attractive option to treat pain and inflammation after ocular surgery with a highly potent anti-inflammatory effect. This could be especially beneficial for high-risk patients, such as diabetic patients, who face an increased risk of complications following ocular surgery due to pre-existing underlying inflammation.”