Oculis terminates Phase III eye drop study due to third-party administrative error

Swiss biopharmaceutical company Oculis is terminating a Phase III clinical trial of its eye surgery therapy OCS-01 after a third-party administrative error compromised the conduct of the study and prevented the analysis of the results, the company said. announced Tuesday.

However, data from another late-stage study and a mid-stage study of the treatment were deemed sufficient by the FDA to file a new drug application in the first quarter of 2025, Oculis said.

OCS-01, Oculis' lead therapy, is being developed to treat postoperative inflammation and pain following eye surgery and diabetic macular edema (DME).

The study to be discontinued is OPTIMIZE-2, which tested the safety of OCS-01 eye drops in patients after cataract surgery. The primary objectives of the study were inflammation and pain.

Oculis did not provide details of the third-party administration error in its second-quarter earnings release, but said it held a pre-NDA meeting for OCS-01 as planned earlier this month to reach agreement with the FDA on the eye drops' regulatory filing. During that meeting, the regulator indicated that data from the completed Phase III OPTIMIZE-1 trial and the Phase II SKYGGN trial for ophthalmic surgery and DME could be used to support the application.

According to CEO Riad Sherif, this would be the first non-disclosure agreement for Oculis.

OCS-01 is also being tested in two clinical trials for DME. The Phase III DIAMOND-1 and DIAMOND-2 trials are currently in the randomization phase, with enrollment exceeding the company's expectations, according to Oculis.