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Ocular Therapeutix reports positive results from phase 3a trial of OTX-DP

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Ocular Therapeutix announced positive top-line clinical results from a phase 3a trial on the safety and efficacy of OTX-DP for the treatment of ocular inflammation and pain after cataract surgery.

The trial enrolled 247 patients who were treated with OTX-DP (sustained-release dexamethasone); 33.7% of patients showed an absence of inflammatory cells in the anterior chamber on day 14 compared with 14.6% of patients who were treated with a placebo vehicle control punctum plug (P = .0015). Seventy-six percent of treated patients reported absence of pain in the study eye on day 8 compared with 36.1% of controls, according to a press 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,” Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said in the release.

The company expects to announce top-line results of a phase 3b clinical trial by the end of the month. If results are positive, a new drug application for OTX-DP will be submitted to the FDA in the second quarter, according to the release.