Patient recruitment completed for stage 1 of phase III DIAMOND study for OCS 01 in diabetic macular edema.- Oculis SA

At the end of 2021, Oculis launched its 2 stage Phase III DIAMOND study, a double-masked, randomized, vehicle-controlled, multi-center, multi-country study of OCS 01 in patients with DME. The primary endpoint of the trial, in both stages, is the mean change in the Best Corrected Visual Acuity “Early Treatment Diabetic Retinopathy Study” chart (BCVA ETDRS) from baseline to Week 6 (stage 1) and to Week 52 (stage 2). Several vision and anatomical secondary endpoints are also planned, including the mean change in macular thickness (CST, central subfield thickness) measured by SD-OCT (spectral domain optical coherence tomography) from baseline. More details can be found at www.clinicaltrials.gov – NCT05066997.

Leveraging Oculis’ proprietary Optireach technology, OCS 01 is a novel, high concentration, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME. Oculis believes that OCS 01, if approved, could open up the possibility of treating DME patients via an eye drop, also offering prescribers the opportunity to provide customized treatment and maximize patient outcomes.