Oculis will not pursue FDA approval for OCS-01, an eye drop for diabetic macular edema, after it failed to meet the primary endpoint in a phase 3 program, according to a press release.
The DIAMOND program included two phase 3 trials that evaluated OCS-01 (dexamethasone 15 mg/mL) in more than 800 patients with DME. Both trials, DIAMOND-1 and DIAMOND-2, failed to meet their primary endpoint of mean change in best corrected visual acuity from baseline to week 52, according to the release.
Both trials showed improvement in retinal thickness measured by OCT, a secondary endpoint of the program,