FEB 25, 2013
Ocular Therapeutix has submitted its Premarket Approval Application to the FDA for ReSure Sealant for intraoperative management of clear corneal incisions.
If successful, it would be the first FDA-approved sealant for ophthalmic use. The proposed indication for ReSure Sealant is intraoperative management of clear corneal incisions with a wound leak as demonstrated by a Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery.
A prospective, randomized, multi-center study compared the sealant with sutures for safety and efficacy within the first seven days following cataract surgery.
"This trial demonstrated that clear corneal incisions may be more vulnerable than previously thought, with zero to minimal touch pressure required to produce a wound leak in 76% of cases," stated Terry Kim, M.D., Professor of Ophthalmology, Duke University Eye Center. "More protection may be necessary to safeguard these incisions, and ReSure Sealant has demonstrated to be a valuable adjunct to clear corneal cataract surgery in this trial."
"We are very pleased with the results of the trial and believe our data set is strong," stated Amar Sawhney, president and CEO of Ocular Therapeutix. "Should FDA view our trial results favorably, we hope to have the opportunity to offer ReSure Sealant to U.S. clinicians later this year."