A panel of experts today voted that Ocular Therapeutix’s ReSure Sealant topical hydrogel post-op sealant is safe, but panelists were split on questions of efficacy and whether the benefits of the treatment outweigh the risks.
The Ophthalmic Devices Panel of the FDA’s Medical Devices Advisory Committee voted 9 to 1, with 1 abstention, that ReSure Sealant is safe; 5 to 3, with 3 abstentions, that it is effective; and 5 to 1, with 5 abstentions, that the product’s 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.
Several panelists during the Gaithersburg, Md., meeting said that some word-smithing to the product’s proposed label would have changed their’ ‘no’ vote to a ‘yes’.
