Ocular Therapeutix recently announced encouraging data derived from one of two Phase 3 trails evaluating the efficacy and safety of the company’s main product candidate Sustained Release Dexamethasone (OTX-DP) aimed to treat pain and ocular inflammation that commonly occurs after cataract surgery.
OTX-DP is a drug placed in the canaliculus that delivers dexamethasone to the ocular surface for about four weeks. After the treatment period, OTX-DP resorbs and exits the nasolacrimal system by itself.
A total of 247 patients were enrolled in the Phase 3a clinical trial. Data showed an improvement in the reduction of pain and inflammation. 33.7% of patients treated with OTX-DP had absence of inflammatory cells in the anterior chamber of the study eye 14 days after OTX-DP insertion, in comparison to 14.6% of patients who received a placebo vehicle control punctum plug.
Data also revealed that 76.1% of the patients who received OTX-DP had no pain in the study eye 8 days after OTX-DP insertion, in comparison to 36.1% of the patients administered with the placebo. The company will continue to assess safety results from the trial.
“This is an exciting day for Ocular Therapeutix as our sustained release drug delivery platform continues to provide strong data in our clinical trials in multiple indications,” said Amar Sawhney, Ph.D., President and CEO in a recent news release. “The ability to administer the entire course of therapy for post-operative inflammation and pain with a single dose would remove the onus from patients to follow complex pharmaceutical dosing regimens while providing the desired tapered therapeutic effect. If we also achieve positive results in our Phase 3b clinical trial, for which we expect to announce topline results by the end of March, we remain on track to submit an NDA to the FDA for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015.”
Ocular Therapeutix announced last November positive data from a Phase 2 study assessing the efficacy and safety of a drug candidate in allergic conjunctivitis, and a new Phase 3 trial will begin by mid 2015.
Currently, Ocular Therapeutix is enrolling patients in a phase 2b study to test the efficacy of another drug candidate OTX-TP (Sustained Release Travoprost) to treat glaucoma and ocular hypertension. Data should be announced by the fourth quarter of 2015.