Oculis Reports OCS-01 Trial Results, Fails to Meet Primary Endpoint
Oculis Holding announced topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema. The DIAMOND program consisted of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment. Over 800 patients were enrolled across both pivotal trials at 119 investigational sites throughout the United States and several other countries. The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study letter score at Week 52, was not met in both trials. The secondary endpoint of retinal thickness, as measured by OCT, showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1. The key secondary endpoint of the proportion of patients with greater than=15-letter gain in BCVA was not met in both trials. OCS-01 was well tolerated, with no unexpected adverse events observed, and the overall safety profile was consistent with that of previous trials. Based on the results, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Riad Sherif, M.D., Chief Executive Officer of Oculis, said: "We are naturally disappointed that the substantial and sustained reduction in retinal thickness observed across both trials didn't translate into BCVA improvement at week 52. In these two trials, our team partnered with 119 global sites across multiple countries and demonstrated excellent execution. We thank the patients, investigators, and all clinical experts who participated in the DIAMOND program. Our strong financial position allows us to execute on our robust late-stage development portfolio. While we finalize the review of DIAMOND program data, we will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies, and the PREDICT-1 trial for Licaminlimab to drive precision medicine in dry eye disease." The Oculis management team will host an analyst and investor call today at 4:30 pm U.S. Eastern Time, to review the topline results and provide a pipeline update, the company noted.
