Ocular Gel Seals Corneal Incision After Cataract Surgery

Once the ReSure material gels, it remains localized over the incision to seal the wound and form a lubricious surface barrier. The hydrogel contains a blue visualization aid to assist with placement over the incision, which dissipates within hours of application. The material is designed to stay on the incision in the immediate postoperative period when wounds are most vulnerable, after which it gently sloughs off in the patient’s tears.

The sealant was evaluated against sutures in a prospective, controlled, randomized, multicenter clinical trial for prevention of fluid egress in clear corneal incisions. ReSure demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases, compared to sutures in only 65.9% of cases. The ReSure Sealant also demonstrated significantly fewer device-related adverse events than the control group, at 1.6% versus 30.6% for sutures. ReSure Sealant is manufactured by Ocular Therapeutix (Bedford, MA, USA), and has been approved by the US Food and Drug Administration (FDA).

“Receiving approval to commercialize this product is a huge milestone for the company,” said Amar Sawhney, PhD, president and CEO of Ocular Therapeutix. “We expect this novel product will enable surgeons to optimize postoperative care of their patients, and look forward to a successful launch in the United States.”

“Eye surgeons have been waiting for an alternative to suture that is easy to apply, comfortable for the patient, and doesn’t require removal following surgery. Beyond those advantages, the ReSure Sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery,” said John Hovanesian, MD, of Harvard Eye Associates (San Clemente, CA, USA), and a principal Investigator in the pivotal clinical trial. “I foresee this device becoming a staple in ophthalmic practices nationwide.”

Cataract surgery is the most commonly performed surgery in the United States, with approximately 3.5 million procedures conducted annually. Clear corneal cataract wound leaks are widely thought to be a contributing factor to postsurgical complications. Presently, ophthalmologists use stromal hydration to close these wounds, but recent reports suggest this method of wound closure may not be adequate to provide a watertight seal.

Related Links:
Ocular Therapeutix
Harvard Eye Associates