Ocular Therapeutix, Inc. announces today the results of its Phase 2 sustained release dexamethasone (OTX-DP) study for the treatment of post-operative inflammation and pain. Ocular Therapeutix’s sustained release dexamethasone is administered as a one-time absorbable intracanalicular plug, designed with a four-week tapered release.
The 60-patient, randomized, placebo-controlled clinical trial was conducted under an Investigational New Drug (IND) submission to the Food and Drug Administration (FDA). Sixty patients undergoing cataract surgery were administered OTX-DP or a proprietary placebo intracanalicular plug at the conclusion of surgery. Primary endpoints included reduction of inflammation as determined by absence of anterior chamber cells and absence of pain.
Results showed that 34.5% percent of patients administered OTX-DP had an anterior chamber cell count of zero on Day 14, opposed to 3.4% of patients in the control group (p=0.0027). The OTX-DP group was statistically superior to the control group for absence of pain at all time-points evaluated through Day 30. One hundred percent of OTX-DP plugs were retained through Day 14, and 96.6% of plugs were retained through Day 28. Results are comparable to commercially available ophthalmic corticosteroids. There were no increases in intraocular pressure related to OTX-DP.
“Placement of the drug product was easy, and patients were comfortable,” stated Thomas Walters, MD, a Principal Investigator in the study. “Reducing the number of post-surgical drops a patient must take while increasing dosing compliance could positively impact healing time and post-operative results.”
Ocular Therapeutix has consulted with the FDA to finalize plans to move the drug product into Phase 3 trials next year. “To the best of our knowledge this is the first randomized, controlled, multi-center clinical study of a sustained release anti-inflammatory agent delivered via intracanalicular plugs, to demonstrate compelling efficacy, ever to be conducted by any company in the U.S. The plugs were highly retained and with less than a 10% drug load compared to drops, and performed excellently in safety as well as efficacy.” stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. “Tailoring therapy with constant low-dose drug on board may not only improve efficacy, but also mean an improved safety profile.”
About Ocular Therapeutix’s Drug Products:
Ocular Therapeutix uses the company’s proprietary absorbable polyethylene glycol hydrogel intracanalicular plug technology to release drugs in a sustained fashion over a specified period of time depending on the drug and its corresponding therapeutic need. At the end of the treatment period, the plug begins to absorb, and exits the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period.
About Ocular Therapeutix, Inc.:
Ocular Therapeutix, Inc. is a privately held company based in Bedford, MA, focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. Ocular Therapeutix is focusing on development of drug-eluting intracanalicular plugs for treatment of glaucoma and post-operative pain and inflammation, sustained release delivery systems for retinal diseases, and the ReSure Sealant, an ocular sealant.
# # #