The U.S. Food and Drug Administration has awarded IDE approval to Ocular Therapeutix in order to carry out a pivotal clinical test with ReSure Sealant. This sealant is a synthetic hydrogel polymer used for ophthalmic applications over apparent corneal incisions.
The efficiency and safety of the sealant device will be tested through the parallel-arm clinical test for avoiding the postoperative fluid egress present on clear incisions of cornea following intraocular lens placement surgery or cataract. The company will conduct clinical trial at up to 24 locations all over the US.
Clear wound leaks in the cornea can cause complications in several post-surgeries. Stromal hydration is currently used by the ophthalmologists in order to close these wounds. According to the new literature, this hydration technique cannot form a waterproof seal, and hence further protection is essential.
Dell Laser Consultants’ Medical Director, Steven Dell commented that this new product can possibly close the analyzed wound integrity, instead of closing the vulnerable cuts with sutures. ReSure sealant can potentially protect the eyes of the patients after the surgery.
Amar Sawhney, Ocular’s CEO and President said that the company is happy that it has developed a robust study with the input of FDA to show the usage of the ReSure Sealant, when compared to previous techniques for closing the incisions. Ocular is expecting to complete the clinical trial and will make the availability of ReSure Sealant to the physicians in the US by 2013.
Source: http://www.ocutx.com/