The company announced Tuesday that despite the error preventing the analysis of late-stage results, the FDA confirmed that data from other completed trials are sufficient to support an NDA submission in the first quarter of 2025.
Swiss biopharma Oculis is shutting down a Phase III clinical trial of ocular surgery therapy OCS-01 after a third-party administrative error impacted the conduct of the study, preventing analysis of the results, the company announced Tuesday.
However, data from another late-stage trial and a mid-stage study for the treatment have been deemed by the FDA to be enough to support a New Drug Application submission in the first quarter of 2025, according to Oculis.
OCS-01, Oculis’ lead therapy, is under development for post-operative inflammation and pain following ocular surgery as well as diabetic macular edema (DME).
The trial to be shuttered is OPTIMIZE-2, which had been testing the safety of OCS-01 eye drops in patients after cataract surgery. The main goals of the trial measured inflammation and pain.
Oculis did not provide details of the third-party administrative error in its second quarter earnings announcement, but said a pre-NDA meeting had been conducted as planned for OCS-01 earlier this month to seek alignment with the FDA on the regulatory filing for the eye drop. During that meeting, the regulator indicated that data from the completed Phase III OPTIMIZE-1 trial and Phase II SKYGGN study for ocular surgery and DME could be used to support its application.
The NDA would be Oculis’ first, according to CEO Riad Sherif.
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 stage, with enrollment exceeding the company’s expectations, according to Oculis.
