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Proposed indications for use factor into FDA panel vote on ReSure Sealant
The panel suggested some revisions on the indications for use.
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GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the U.S. Food and Drug Administration affirmed the safety and benefit-risk profile of ReSure Sealant in a September vote.
The panel considered a premarket approval application submitted by Ocular Therapeutix in August 2012. Some members were concerned about safety, indications, labeling and post-market study criteria.
“Many panel members stated that their votes were based on the current [indications for use],” according to an FDA summary of the meeting. “However, if the proposed [indications for use] were modified based on the discussion during deliberations, the panel would have voted more favorably.”
The proposed indication for ReSure Sealant is intraoperative management of clear corneal incisions with a wound leak demonstrated by a Seidel test and prevention of postoperative fluid egress after cataract surgery or IOL surgery. There are no devices currently approved in the United States for that indication.
Panel vote
The panel recommended that the proposed indications for use be revised to eliminate any suggestion of prophylactic use of ReSure Sealant. It also recommended that maximum incision width be specified in the indications for use.
Nine members voted yes and one voted no, with one abstention, on the question, “Is there reasonable assurance that the ReSure Sealant is safe for use in patients who meet the criteria specified in the proposed indication?”
The question, “Is there reasonable assurance that the ReSure Sealant is effective for use in patients who meet the criteria specified in the proposed indication?” garnered five yes votes and three no votes, with three abstentions.
Five members voted yes and one voted no, with five abstentions, on the question, “Do the benefits of the ReSure Sealant for use in patients who meet the criteria specified in the proposed indication outweigh the risk for use in the patients who meet the criteria specified in the proposed indication?”
Comments and questions
During deliberations before the panel vote, panel consumer representative Lawrence E. Leguire, PhD, MBA, aired concerns about cross-contamination if one package of ReSure Sealant is used in multiple patients.
“The material is labeled and packaged for single use. It would be very difficult and against all sorts of standards of care in operating rooms for a surgeon to try to do that, essentially, because of the way it’s packaged. You’d have to contaminate one patient’s body fluids or the surgical environment, and you’d essentially have to discard it,” John A. Hovanesian, MD, FACS, a consultant for Ocular Therapeutix and OSN Cataract Surgery Section Editor, said.
Hovanesian addressed some members’ concerns about study patients aged 80 years or older in the ReSure group who had higher pain scores than those in the suture group.
“In all cases, [ReSure] patients were fairly comfortable, and the differences were not great,” Hovanesian said.
Leguire asked if ReSure may be used in conjunction with sutures.
“It’s going to depend upon the wound configuration. A suture has a different type of functionality from a sealant,” Hovanesian said. “This sealant is better than suture, but suture provides deep and forceful apposition of wound surfaces where that’s needed.”
Post-approval study design
The panel affirmed the need for Ocular Therapeutix to conduct a post-approval study to gather more data on safety endpoints.
“Theoretically, the benefits of closing the wound seem to outweigh the risks and the device seems quite safe, but the real benefits of it are yet to be known,” panel member Winston D. Chamberlain, MD, PhD, said after the third vote.
“As a patient, I feel strongly that for any new product or device, you must have such a program in place,” patient representative Barbara D. Berney said.
The post-approval study will include at least 760 patients and be conducted at up to 40 centers in the U.S. It is designed to confirm that ReSure Sealant can be used safely by physicians in a standard cataract surgery practice and confirm the incidence of adverse events in eyes treated with the sealant.
As proposed, the primary endpoints would be anterior chamber cells greater than level 1+ persisting at postoperative visit two, postoperative IOP of 30 mm Hg or greater or 10 mm Hg over baseline, and posterior vitreous detachment. Endpoints also would include pain, foreign body sensation and endophthalmitis.
During panel deliberations, member Neil M. Bressler, MD, said that IOP should be well-defined and that posterior vitreous detachment is unlikely and should be removed from post-approval study as a study endpoint.
Member Alice Y. Matoba, MD, called for including wound leakage as a primary endpoint. Jayne S. Weiss, MD, called for including late persistent wound leakage and a longer follow-up period.
Chamberlain suggested that the post-approval study partly focus on diabetic patients, who are at increased risk of wound-healing problems. – by Matt Hasson