Oculis Halts Phase III OPTIMIZE-2 Trial for OCS-01 Due to Third-Party Oversight, NDA Filing Unaffected

Recently, Oculis, a Swiss biopharmaceutical company focused on ophthalmology, has halted a Phase III clinical trial of its core pipeline product OCS-01, as administrative errors by a third-party organization impacted the study’s progress and prevented the analysis of results.

Nevertheless, according to Oculis, the FDA believes that data from another late-stage trial and a mid-stage study are sufficient to support the company's submission of a new drug application for OCS-01 in the first quarter of 2025.

OCS-01 is Oculis' core pipeline, a type of dexamethasone topical eye drop developed using Oculis' proprietary OPTIREACH® technology platform. This technology platform addresses the limitations of traditional eye drops in treating posterior segment ocular diseases by enhancing the solubility of lipophilic drugs, increasing drug retention time on the ocular surface, and promoting drug delivery from the ocular surface to the fundus.

The trial that is about to be stopped is OPTIMIZE-2, which has been testing the safety of OCS-01 eye drops in patients after cataract surgery. The primary objective of the trial is to measure inflammation and pain.

Oculis did not provide details on the third-party management error in its second-quarter earnings report but stated that it had held the planned NDA meeting for OCS-01 earlier this month to seek regulatory feedback from the FDA regarding the eye drop.

At that meeting, the regulatory agency indicated that the data from the completed Phase III OPTIMIZE-1 trial for ophthalmic surgery and DME, as well as the Phase II SKYGGN study, could be used to support its application for market approval.

Currently, in addition to OCS-01, Oculis also has OCS-02, a TNF-α monoclonal antibody for the treatment of dry eye disease, and OCS-05, an SGK2 agonist for ocular neuropathy.