Dexamethasone punctum plug shows positive results

Data from a phase 3 study shows that a dexamethasone-releasing absorbable punctum plug from Ocular Therapeutix can control pain and reduce inflammation following cataract surgery.

The sustained-release dexamethasone device is placed in the canaliculus and delivers dexamethasone to the ocular surface for approximately four weeks. Following treatment, the plug resorbs and exits the nasolacrimal system, without need for removal.

A phase 3a study including 247 patients showed 33.7% of treated eyes demonstrated an absence of inflammatory cells in the anterior chamber 14 days after insertion, compared to 14.6% of those receiving placebo vehicle control punctum plug (P = 0.0015). In addition, 76.1% of treated patients reported absence of pain in the treated eye 8 days after plug insertion, compared to 36.1% of those receiving placebo vehicle control punctum plug (P < 0.0001). 

“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,” said Amar Sawhney, PhD, president and CEO of the company. “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.”

The company is investigating additional uses of the device. A phase 3 trial for allergic conjunctivitis is expected to get underway in mid-2015, and an exploratory phase 2 trial for inflammatory dry eye began in January. Meanwhile, a phase 2b trial of the company’s second punctum plug product, for sustained release travoprost, is currently enrolling patients with glaucoma and ocular hypertension. Data from this trial is expected in the fourth quarter of 2015.