Ocular Therapeutix Reports Positive Topline Clinical Data for Phase 3a Clinical Trial Evaluating OTX-DP for the Treatment of Postoperative Inflammation and Pain
Friday, March 13, 2015 |
Ocular Therapeutix announced positive topline data from the first of two phase 3 clinical trials evaluating the safety and efficacy of its lead product candidate, OTX-DP (dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery, according to a company news release.
The phase 3a study, which enrolled 247 patients, met both primary efficacy measures, achieving a statistically significant improvement in the reduction of inflammatory cells and pain. According to the study, 33.7% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 14.6% of those receiving placebo vehicle control punctum plug (P = .0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day 8 following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctum plug (P < .0001). Ocular is continuing to analyze the safety findings from the clinical 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,” Amar Sawhney, PhD, President and CEO of Ocular Therapeutix, said in the news release. “The ability to administer the entire course of therapy for postoperative 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.”
OTX-DP is a product candidate placed in the canaliculus and designed to deliver dexamethasone to the ocular surface for approximately 4 weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal system without need for removal. In November 2014, the company announced encouraging data from its phase 2 clinical trial evaluating the safety and efficacy of OTX-DP in allergic conjunctivitis and the company plans to initiate phase 3 clinical trials for this indication in the middle of 2015, according to the news release.
The company also initiated an exploratory phase 2 clinical trial of OTX-DP for the treatment of inflammatory dry eye in January 2015. The company is currently enrolling patients into a phase 2b clinical trial of its second sustained release product candidate, OTX-TP (travoprost), for the treatment of glaucoma and ocular hypertension. Data from this trial is expected in the fourth quarter of 2015.
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