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 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.