Ocular completes patient enrolment in two Phase III trials of dexamethasone

9th October 2014 (Last Updated October 9th, 2014 18:30)

US-based biopharmaceutical firm Ocular Therapeutix has completion patient enrolment in two of its Phase III clinical trials evaluating sustained release dexamethasone (OTX-DP) to treat ocular inflammation and pain following cataract surgery.

US-based biopharmaceutical firm Ocular Therapeutix has completion patient enrolment in two of its Phase III clinical trials evaluating sustained release dexamethasone (OTX-DP) to treat ocular inflammation and pain following cataract surgery.

The company said that OTX-DP is a one-time administration product candidate placed in the canaliculus and is designed to deliver dexamethasone to the ocular surface for about four weeks.

After treatment, OTX-DP resorbs and exits the nasolacrimal system without the need for removal.

About 486 patients at 32 sites across the US have been enrolled in the two prospective, multicentre, randomised, parallel-arm, double-masked, vehicle-controlled trials.

Following cataract surgery, patients were given either OTX-DP or a placebo vehicle punctum plug without active drug.

Primary efficacy endpoints of the trials are the absence of inflammatory cells in the anterior chamber of the eye at day 14, and reduction of pain at day eight.

Ocular Therapeutix president and CEO Amar Sawhney said: "Completion of enrolment for OTX-DP is an extraordinary milestone for our company, not only as our first Phase III clinical trials for a sustained release pharmaceutical, but also the first Phase III trials ever to be completed for a sustained release, drug delivery punctum plug.

"We look forward to submitting results to the FDA in 2015."

"We look forward to submitting results to the FDA in 2015."

Typically, topical corticosteroids are prescribed for the treatment of ocular inflammation and pain following ophthalmic surgery.

The company said that chronic administration of topical corticosteroids can lead to spikes in intraocular pressure, which may induce glaucoma.

Texan Eye principal investigator Dr Thomas Walters said: "OTX-DP is easily inserted, and can be monitored by the physician during the post-operative period.

"In a previously completed Phase II clinical trial, treatment with OTX-DP significantly relieved pain at day eight, as reported by the patient, and inflammation at day 14, as measured by absence of inflammatory cells in the anterior chamber of the eye, compared to vehicle control, and patients were comfortable with the plug."