Ocular Therapeutix (NSDQ:OCUL) said it’s ready to start a pair of Phase III studies of its drug-eluting eye-duct plug in the treatment of pain and inflammation following with cataract surgery.
The product, sustained release dexamethasone, or OTX-DP, is placed in the lacrimal duct of the eye to deliver low doses of the corticosteroid dexamethasone to the eye’s surface. After a 4-week period, the plug eventually dissolves, eliminating the need for removal.
Topical corticosteroids are typically prescribed to treat eye inflammation and pain following surgery, but the regimens can be complex and hard to follow. The eye-duct plug would help patients adhere to their post-surgical regimens, according to the company.
The 2 late-stage clinical trials will track approximately 500 patients at 32 sites throughout the U.S. The company said it hopes to be able to submit results to the FDA in 2015.
If approved, OTX-DP would be Ocular Therapeutix second product on the market. The company first product, ReSure Sealant, is approved to seal corneal incisions following cataract surgery.
Ocular Therapeutix went public July 30, raising almost $75 million.