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Oculis Discontinues Phase III OCS-01 Trial Due to Administrative Error, Still Eyes 2025 NDA Submission

• Oculis is halting the Phase III OPTIMIZE-2 trial of OCS-01 eye drops for post-cataract surgery due to a third-party administrative error that compromised data analysis. • The FDA has indicated that data from the Phase III OPTIMIZE-1 trial and Phase II SKYGGN study are sufficient to support a New Drug Application (NDA) for OCS-01. • OCS-01 is being developed for post-operative inflammation and pain following ocular surgery, as well as diabetic macular edema (DME). • The NDA submission for OCS-01, which would be Oculis’ first, is planned for the first quarter of 2025.

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.
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Reference News

[1]
Oculis Closes Phase III Eye Drop Trial Due to Third-Party Administrative Error - BioSpace
biospace.com · Aug 27, 2024

Oculis halts Phase III trial of OCS-01 due to third-party error, but FDA accepts data from other trials for NDA submissi...

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