Ocular Therapeutix, Inc. announced today it has completed enrollment for its sustained release dexamethasone (OTX-DP) in a Phase II study under an Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).
This study will evaluate the safety and efficacy of the OTX-DP for the treatment of post-operative inflammation and pain. Ocular Therapeutix’s sustained release dexamethasone is administered as a one-time bioabsorbable intracanalicular plug, and releases the corticosteroid to the ocular surface over a two-week period followed by a two-week taper.
Sixty patients undergoing clear corneal cataract surgery were enrolled at four sites in the United States. Patients randomized to the OTX-DP study arm were administered the drug-eluting plug at the conclusion of surgery, and a proprietary placebo intracanalicular plug was placed in the control group. Primary endpoints are reduction of inflammation and pain.
Patients do not reliably self-administer steroids post-surgery, and as a result risk greater or more persistent post-operative inflammation that can ultimately compromise visual outcomes. In addition, topical steroids are known to induce spikes in intraocular pressure. “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 Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc.
About Ocular Therapeutix’s Drug Products:
Ocular Therapeutix uses the company’s proprietary bioabsorbable polyethylene glycol hydrogel intracanalicular plug technology to release proven and approved 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.:
Founded in November 2006, 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, injectable depots for back-of-the-eye diseases, and an ocular sealant.
# # #