Oculis Holding AG has completed enrollment in both phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND trials are designed as pivotal registration studies to support global marketing applications including new drug application (NDA) submission and approval by the US Food and Drug Administration (FDA), Oculis said in a press release.

DIAMOND consist of 2 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. More than 800 patients are enrolled at 119 investigative sites throughout the United States and other countries, according to the company’s press release. Oculis expects topline data from both phase 3 trials in the second quarter of 2026, with NDA submission to follow thereafter.

If approved, Oculis said OCS-01 is expected to become the first topical eye drop for the treatment of DME and address unmet medical needs for early treatment intervention or for patients with inadequate response to anti-VEGF therapy.