Oculis closes Phase 3 eye drop trial due to ‘administrative error’ from third party
Today’s cyclodextrin is some news fresh from Oculis‘s oven about the lead drug OCS-01, which is delivered with a unique and proprietary cyclodextrin technology.
The company reported in its second-quarter financial filing that a Phase 3 trial for Oculis’ lead eye drop candidate will be shut down due to an administrative error.
The company added, however, that it had a pre-NDA meeting with the FDA this month, where it got the go-ahead to still file for approval in the first quarter of next year. According to Oculis, the agency confirmed the data it already has from its first Phase 3 trial and a Phase 2 trial, alongside safety data from other studies in ocular surgery and diabetic macular edema, are enough to support an NDA submission.
I’m so happy that this unfortunate event does not seem to hold back the progress of this amazing drug and technology.
If OCS-01 is approved, it would be the first daily and preservative-free steroid for treating inflammation and pain following ocular surgery.
