Oculis Holding has completed enrollment in the 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), the company said in a press release.

The DIAMOND program consist of a pair of double-masked, randomized, multicenter 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. Oculis expects topline data from the phase 3 trials in the second quarter of 2026.

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. RP