Ocular Therapeutix wrapped up patient enrollment for a Phase II trial evaluating the company’s OTX-DP tear duct plug, the company announced this week.
The study included 60 patients recovering from corneal cataract surgery. Patients were divided into 2 treatment groups – one was treated with anti-inflammatory steroids delivered by Ocular’s plug and the other was given a placebo plug with optional rescue medication in case of persistent inflammation, a company spokesperson told MassDevice.com.
Each patient was observed over a 2-week period with the tear duct plug in place, and Ocular expects it will have all patient results in July.
The Bedford, Mass.-based company developed its drug-eluting plug with help of a series of funding rounds and is currently pursing an investigational new drug submission with the FDA.
Ocular developed the drug/device combo as an alternative to delivering post-surgery medication via patient-administered eye drops. The plug, inserted in the tear duct, automatically delivers drugs to the surface of the eye.
"A sustained, low-dose dexamethasone plug could ensure consistent and continuous corticosteroid concentrations on the ocular surface, which may in turn minimize side effects and achieve better results," said CEO Amar Sawhney in prepared remarks.
In January the company closed a nearly $24 million Series D extension round that Sawhney told MassDevice.com he intended to use to develop the plug technology.