UPDATE: FDA panel approves Ocular Therapeutix’ ReSeal, with reservations

FDA panel approves Ocular Therapeutix' ReSeal, with reservations

An FDA advisory panel voted yesterday that Ocular Therapeutix’s ReSure topical hydrogel post-op sealant is safe, but split on questions of efficacy and whether the benefits of the treatment outweigh its risks.

The FDA’s Ophthalmic Devices Panel voted 9-1, with 1 abstention, that the ReSure sealant is safe; 5-3, with 3 abstentions, that it is effective; and 5-1, with 5 abstentions, that its benefits outweigh its risks.

Ocular Therapeutix filed for PMA approval in February, based on a 488-patient clinical trial. The sealant’s proposed indication is for temporary sealing of clear corneal incisions to prevent leakage of fluid after cataract or intraocular lens placement surgery. While the FDA is not bound by the recommendations of its advisory panels, the agency often follows their advice.

Some panelists said they were unable to adequately assess the benefits vs. the risks of ReSure or whether it proved superiority over suture, given the conduct of the study, which included 370 protocol deviations.

Several panelists during the Gaithersburg, Md., meeting said that some word-smithing to the product’s proposed labelling would have changed their "no" votes on effectiveness to "yes."

Labeling is important "so that surgeons don’t imagine this is the same as a stitch," panelist Dr. Jayne Weiss of LSU Health Science Center in New Orleans said.

"The labeling is controlled by FDA and typically negotiated between the company and FDA," Ocular Therapeutix president & CEO Amar Sawhney told MassDevice.com. "So it will undergo some minor modifications, in all likelihood, but I cannot say what they will be."

Weiss also noted that Ocular Therapeutix conducted a 7-day study, rather than a 1- or 2-month study.

"I’m disturbed by it, because it doesn’t last very long and it doesn’t do very much," Weiss said. "It lasts less than 3 days, [but] that might be enough."

"You do not want to give the impression that this assures a healed wound," added Dr. Alice Matoba of Baylor College of Medicine in Houston. "It assures intact epithelium within a few days of the surgery, and that probably is helpful.

"But in no way does it keep the wound from leaking if there’s additional minor trauma, so I’m concerned that patients and clinicians may be lulled into a false feeling of security that they apply it and it’s done," Matoba said. "It only promotes epithelial healing and that has limited effectiveness, so how you define effectiveness would alter my answer to the question."

ReSure’s proposed Indication for Use is: "For intraoperative management of clear corneal incisions with a wound leak demonstrated by a Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery," according to the FDA. There are no devices approved in the U.S. for such an indication, the watchdog agency said ahead of the meeting.

The word "and" in the current IFU implies a prophylactic use for ReSure, and possibly 2 different uses for the sealant, according to panelists, which was not intended by the sponsor. This should be corrected, they advised the FDA.

The product’s proposed IFU also does not specify incision architecture or maximum length, the FDA pointed out. Panelists said a maximum incision width less than or equal to 3.5 mm should be identified as a prerequisite for use of ReSure.

The panel was split on whether incision architecture needed to be specified, but a strong argument was made in favor of leaving this to the surgeon’s discretion.

Panelists affirmed the need for a post-approval study and suggested some modifications to the proposed safety endpoints, including adding an assessment of wound leak, eliminating posterior vitreous detachment and getting "creative" with the assessment of endophthalmitis.

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