Ocular Therapeutix (NSDQ:OCUL) announced today that its Phase 2 clinical trial for treating dry eye disease (DED) did not meet its primary endpoint.
Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based, randomized, double-masked, multi-center, vehicle-controlled Phase 2 clinical trial evaluated OTX-CSI (cyclosporine intracanalicular insert) for treating DED by measuring signs and symptoms of DED in 140 subjects treated in both eyes over approximately 16 weeks.
The study did not demonstrate separation between the OTX-CSI-treated subjects and the vehicle-treated subjects for the primary endpoint of increased tear production at 12 weeks, according to a news release.
Ocular Therapeutix’s study did observe an improvement compared with baseline in signs of dry eye starting as early as two weeks after insertion and continuing over the 12-week study period. However, those improvements were not statistically significant compared with the vehicle insert.
Overall, the OTX-CSI insert was observed to have a favorable safety profile and was well tolerated with no ocular serious adverse events. The most common ocular adverse event was ocular pruritus, which was seen in less than 16% of subjects.
“We would like to thank the patients and investigators who participated in the OTX-CSI clinical trial,” Ocular Therapeutix President and CEO Antony Mattessich said in the release. “While we are disappointed by these results, demonstrating clinical benefit in patients with dry eye disease remains a significant unmet need and we will continue to review the data for additional information that may inform future development of this program. We remain confident in the potential of our hydrogel-based formulation technology and its ability to deliver innovative ophthalmology therapies. We look forward to our anticipated Phase 2 top-line read out for OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
“In addition, we expect to provide updates on other pipeline programs being developed to treat glaucoma and wet-AMD as well as updates on our currently marketed product, Dextenza, which recently received FDA approval to expand its label for the treatment of ocular itching associated with allergic conjunctivitis.”
