Oculis, a Swiss biopharmaceutical company, has announced the discontinuation of its Phase III OPTIMIZE-2 clinical trial evaluating OCS-01 eye drops for the treatment of inflammation and pain following cataract surgery. The decision was prompted by a third-party administrative error that compromised the integrity of the study, preventing a thorough analysis of the results. Despite this setback, the company remains on track for a New Drug Application (NDA) submission to the FDA in the first quarter of 2025.
Regulatory Path Forward for OCS-01
According to Oculis, the FDA has determined that data from the completed Phase III OPTIMIZE-1 trial and the Phase II SKYGGN study provide sufficient evidence to support the NDA submission for OCS-01. This guidance was received during a pre-NDA meeting with the regulatory agency earlier this month. OCS-01 is being developed for post-operative inflammation and pain following ocular surgery, as well as diabetic macular edema (DME).
Details of the Discontinued Trial
The OPTIMIZE-2 trial was designed to assess the safety of OCS-01 eye drops in patients undergoing cataract surgery. The primary endpoints of the trial focused on measuring inflammation and pain reduction. Oculis has not disclosed specific details regarding the nature of the third-party administrative error that led to the trial's termination.
Ongoing Development in Diabetic Macular Edema
In addition to its application in post-operative care, OCS-01 is also under investigation for the treatment of DME. The Phase III DIAMOND-1 and DIAMOND-2 trials are currently in the randomization stage, with enrollment exceeding the company's initial projections. These trials aim to evaluate the efficacy and safety of OCS-01 in patients with DME.
Oculis' Perspective
"The NDA would be Oculis’ first," stated CEO Riad Sherif, highlighting the significance of this regulatory milestone for the company.
