First Gel Sealant for Corneal Incision Approved
The FDA has approved ReSure Sealant (Ocular Therapeutix), the first gel sealant to stop fluid leakage through the incision in a patient's cornea after cataract surgery with intraocular lens placement in adults.
ReSure Sealant is a synthetic, biocompatible hydrogel that creates a temporary lubricious surface barrier to protect clear corneal incisions in the immediate post-operative period.
Once applied, a gel forms and adheres to the eye to seal the incision. This gel breaks down over a period of 7 days and is cleared from the body by the eye's natural tears.
The approval was based on several non-clinical and clinical studies, including a randomized trial of adult patients (n=471) who underwent cataract surgery and experienced leakage from their incision at the time of operation. Of the 471 patients, 295 received the ReSure Sealant and 176 received a suture to stop leakage.
Results showed that ReSure Sealant was more effective than a single suture in preventing incision leakage in the first seven days following cataract surgery.
The ReSure Sealant kit comes as two liquid solutions that the surgeon mixes together just prior to sealing the incision.
For more information call (877) 628-8998 or visit OcuTx.com.