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FDA approves ReSure sealant for preventing fluid leaks after cataract surgery
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The U.S. Food and Drug Administration approved ReSure sealant for sale in the U.S., Ocular Therapeutix announced Jan. 9.
ReSure sealant is indicated for “the prevention of postoperative fluid egress from incisions with demonstrated wound leak following cataract surgery,” the company said in a press release. It is the first product of its kind to be approved by the FDA for ophthalmic use.
“Receiving approval to commercialize this product is a huge milestone for the company,” Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said in the release. “We expect this novel product will enable surgeons to optimize postoperative care of their patients and look forward to a successful launch in the U.S.”
First applied as a liquid, the polyethylene glycol-based hydrogel becomes a gel within 20 seconds of application on the surface of the eye, localizing over the incision, sealing the wound and forming a surface barrier. ReSure sealant remains on the incision during the vulnerable period immediately postoperatively and then dissipates in the patient’s tears, according to the release.
The FDA’s Ophthalmic Devices Panel voted to recommend approval of ReSure sealant in September.
Members overwhelmingly affirmed the product’s safety and benefit-risk profile. However, some members voiced concern about safety, indications, labeling and postmarket study criteria.
The panel also affirmed the need for Ocular Therapeutix to conduct a post-approval study to gather additional data on safety endpoints.
Perspective
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John A. Hovanesian, MD, FACS
FDA approval of ReSure sealant is very big news for ophthalmology. For the first time in decades, we have a new option for sealing leaking incisions. While sutures have long been the gold standard, there are many barriers to their use in the real world, including patient discomfort, inducement of astigmatism, and the not-so-trivial time and surgical technique required to place them properly. Furthermore, recent studies in which sutured wounds were challenged with external force have shown they are far from perfect in keeping wounds sealed.
While not a complete replacement for suture, ReSure is a material that offers a very valuable alternative. It adheres well to the ocular surface, bridging across and sealing closed corneal incisions. It prevents these wounds from leaking, even when they are challenged by fairly rigorous external forces. This is a tool that should be in every surgeon’s armamentarium.
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