Ocular Therapeutix won the FDA's backing for a gel designed to seal leaks in incisions made during cataract surgery, the first product of its kind to gain regulatory approval in the U.S. for use in the eyes.
The Bedford, MA-based company gained premarketing approval after convincing the FDA's Ophthalmic Devices Panel in September that its ReSure Sealant is both safe and effective on corneal wounds. Cataract surgery requires an incision so surgeons can replace a patient's own lens with a new artificial one, and ReSure is designed to prevent leaking from the incision that can take place after the procedure. Before ReSure, surgeons have typically relied on stitches to do the job.
Regulators limited ReSure's use, however, to cataract surgery patients with clear corneas--hitting an earlier stage of the degenerative condition. The FDA also wants Ocular to carry out a postapproval study on at least 4,857 patients under the approval criteria in order to gather more information on the rate of potential problems connected to ReSure. Cataracts cause vision loss through a gradual clouding of the eye's lens over time.
Ocular execs could not be reached for comment on deadline. But FDA officials, in announcing their approval, noted they used a number of nonclinical and clinical studies to make their decision, including a randomized trial involving 471 adults who underwent cataract surgery and had leakage from the surgical incision. Out of that total, 295 patients got the ReSure sealant option and surgeons used sutures for the other 176. Overall, that trial showed that ReSure was more effective in preventing leakage from the incision in the first week after cataract surgery, and both options produced similar rates of corneal swelling, inflammation and wound healing.
ReSure, a synthetic hydrogel, starts out as a liquid but assumes gel form after application. It hydrolyzes over time and patients discharge it through their tears.
ReSure could gain some serious market traction simply because of the U.S.'s rapidly aging population, as cataracts typically occur in older patients. The FDA, in its approval announcement, cited NIH statistics that highlight ReSure's potential reach: By age 80, more than half of all U.S. patients either have cataracts or have already had cataract surgery.
- read the FDA's release