FDA Panel Recommends ReSure Sealant From Ocular Therapeutix

The Ophthalmic Devices Panel of the U.S. Food and Drug Administration (FDA) has recommended that ReSure Sealant from Ocular Therapeutix, Inc., Bedford, Mass., be approved by the agency, voting in favor of the company’s premarket approval (PMA) application. The sealant is designed for the management of clear corneal wound leaks following cataract surgery. The PMA was submitted in February.

The panel vote was mixed however. Panelists voted 9-1, with 1 abstention, that the sealant is safe; 5-3, with 3 abstentions, that the sealant effective; and 5-1, with 5 abstentions, that the product’s benefits outweigh its risks. The panel also raised concerns about the product’s labeling and wanted to ensure that changes were made so that physicians understand the difference between ReSure and traditional suturing.

During this meeting, the panel reviewed data from the ReSure Sealant Pivotal Study, a 488-patient controlled, multi-center, randomized, prospective clinical trial. For the primary endpoint of prevention of wound leaks within the first seven days post-operatively, the ReSure Sealant demonstrated statistical superiority over sutures. The ReSure Sealant successfully prevented wound leaks in 95.9 percent of cases, compared to sutures at a rate of only 65.9 percent. Use of the ReSure Sealant was associated with fewer adverse events when compared to suture and was well-tolerated by patients, the company reported.

“Prior to device application, nearly half of all clear corneal wounds spontaneously leaked in the trial, while the majority of remaining incisions leaked with minimal provocation,” said Amar Sawhney, president and CEO of Ocular Therapeutix, Inc. “Surgeons may overestimate the integrity of clear corneal incisions and may not consider forces which may be encountered by the wound post-operatively. Suturing has so far been the best definitive recourse for treating leaking wounds, however, in this trial the ReSure Sealant was demonstrated to be superior to sutures for management of wound leaks. Additionally, there were fewer device-related and total adverse events in the ReSure Sealant group, thus establishing a strong safety profile. We are pleased that the panel has recognized this important advance with their vote of confidence and look forward to working with FDA toward approval of the ReSure Sealant.”

ReSure is a synthetic, polyethylene glycol-based hydrogel which is applied as a liquid and gels in situ on the ocular surface, creating a soft and lubricious surface sealant. The ReSure hydrogel is designed to stay on the incision in the immediate post-operative period when wounds are most vulnerable, after which it hydrolyzes and gently sloughs off in the patient’s tears.

Cataract surgery is one of the most commonly performed surgeries 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 some post-surgical complications. At present, ophthalmologists use stromal hydration to close these wounds, however, recent reports in clinical journals suggest this method of wound closure may not be adequate to provide a watertight seal.

FDA approval of an ophthalmic sealant would provide surgeons a novel means of wound closure for vulnerable incisions.

Ocular Therapeutix Inc. was founded in 2006 and is privately held. The firm focuses on developing drug-eluting intracanalicular plugs for treatment of glaucoma and post-operative pain and inflammation, injectable depots for back-of-the-eye diseases, and an ocular sealant.

In June, Ocular raised $8.5 million in a Series E round of equity financing from Ascension Health Ventures and Baxter Ventures. The round followed an extension of its $23 million Series D round of funding led by Ascension Health Ventures, which closed in November 2012.

The FDA doesn’t have to follow its panel’s recommendations, but it usually does.