A Phase 3 trial for Oculis’ lead eye drop candidate will be shut down due to an administrative error, the company reported in its second-quarter financial filing.
The OPTIMIZE-2 trial was investigating once-daily eye drops, dubbed OCS-01, for the treatment of post-operative inflammation and pain following ocular surgery. But due to “a third-party administrative error which affected the conduct of the trial and prevents analysis of trial results,” the study will be closed.
Oculis declined to elaborate more on the issue that led to the trial shutdown, citing confidentiality, but said in a statement to Endpoints News that patient safety “was not compromised.”
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.
If OCS-01 is approved, it would be the first daily and preservative-free steroid for treating inflammation and pain following ocular surgery, Oculis said. The company did not immediately return a request for comment.
A topline readout from OPTIMIZE-2 was originally anticipated in the fourth quarter of this year, according to Oculis’ previous financial report. At the time, it said the data from the two OPTIMIZE trials would make up the NDA submission to the FDA.
According to the company’s website, OCS-01 is also in a Phase 3 trial for diabetic macular edema and in Phase 2 for cystoid macular edema.
In the OPTIMIZE-1 study, which read out last August, OCS-01 was tested as a treatment of post-cataract surgery inflammation and pain. The trial showed statistically significant improvements over a vehicle in co-primary endpoints of inflammation and pain: 57.2% of participants had zero inflammation compared with 24% in the vehicle comparator group (p<0.0001) 15 days after surgery.
The biotech closed a $59 million stock sale in April that would extend its runway through 2026. Oculis is also developing other candidates for ocular conditions, including licaminlimab in dry eye disease, for which it touted Phase 2 results in June. But while the results favored the drug, Oculis stopped short of calling the data statistically significant.
Editor’s Note: This story has been updated to include additional comment from Oculis.