Ocular Therapeutix Waiting for Word from FDA

Ocular Therapeutix expects to hear from the FDA on its PDUFA date of July 24, 2016, on its new drug application for DEXTENZA, its sustained-release dexamethasone intracanalicular depot drug product candidate for treatment of postoperative pain, President and CEO Amar Sawhney, PhD, told the audience at OIS@ASCRS during the Ophthalmology Innovation Showcase.

DEXTENZA would be the first FDA-approved sustained-release ophthalmic drug product, and involves insertion of a preservative-free, drug-loaded depot into the punctum. After treatment, the plug resorbs and exits the nasolacrimal system without the need for removal.

Ocular Therapeutix is also pursuing other indications for DEXTENZA, Dr. Sawhney said: postoperative ocular inflammation, allergic conjunctivitis, and signs and symptoms of dry eye disease.

Meanwhile, the company is investigating a sustained-release depot for treatment of glaucoma. In April Ocular Therapeutix announced it had completed its end-of-Phase II review with the FDA for its OTX-TP sustained-release travoprost, which is a 90-day preservative-free depot for the treatment of glaucoma and ocular hypertension. The firm is involved in planning its first Phase III trial of OTX-TP. Dr. Sawhney said clinical trials should begin “in the third quarter of 2016.”

Ocular Therapeutix is also pursuing development of sustained-release (up to six months) injections of anti-VEGF agents and small molecules such as TKIs for age-related macular degeneration (AMD), Dr. Sawhney said. This would involve what he called “shape memory hydrogels” injected into the vitreous. The hydrogels would break down over months to deliver these agents in steady, sustained dosing.

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