Regulatory News

FDA panel recommends approval of ReSure Sealant with some concerns

GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the U.S. Food and Drug Administration voted to recommend approval of ReSure Sealant.

Members overwhelmingly affirmed the product’s safety and benefit-risk profile. However, some members voiced concern about safety, indications, labeling and postmarket study criteria.

ReSure Sealant (Ocular Therapeutix) is indicated 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 surgery or intraocular lens surgery.

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?”

The panel also 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,” Winston D. Chamberlain, MD, PhD, said after the third vote.

GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the U.S. Food and Drug Administration voted to recommend approval of ReSure Sealant.

Members overwhelmingly affirmed the product’s safety and benefit-risk profile. However, some members voiced concern about safety, indications, labeling and postmarket study criteria.

ReSure Sealant (Ocular Therapeutix) is indicated 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 surgery or intraocular lens surgery.

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?”

The panel also 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,” Winston D. Chamberlain, MD, PhD, said after the third vote.