TAGS: Sealants
Ocular Therapeutix, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, has received notification from the U.S. Food and Drug Administration (FDA) confirming it has fulfilled all post-approval study requirements for ReSure® Sealant, with a requirement to update the ReSure® label reflecting the study results.
As a condition for ReSure®’s pre-market approval application (PMA) in 2014, the FDA required two post-approval studies to be completed. The first, referred to as the Clinical Post-Approval Study, was completed in 2016.
This notification marks the completion of the second, the Device Exposure Registry Study, a retrospective analysis comparing endophthalmitis rates from sites that purchased ReSure® Sealant versus sites that did not.
Sealant for Clear Corneal Incisions
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We are happy to have completed the FDA’s post-approval requirements for our ReSure® Sealant product” said Antony Mattessich, president and chief executive officer of Ocular Therapeutics. “
ReSure® is well-regarded by anterior segment surgeons and this study only adds to the body of knowledge supporting its use.”
This retrospective study evaluated endophthalmitis rates at sites with access to ReSure® compared with the rate at sites without access to ReSure® using the American Academy of Ophthalmology’s IRIS® Registry (Intelligent Research in Sight) database.
In total, 6.7 million eyes that underwent cataract surgery with insertion of an intraocular lens between January 2016 and December 2019 were evaluated in the study. The endophthalmitis rates for sites with access to ReSure® was 0.609 per 1,000 surgeries, compared with 0.660 per 1,000 surgeries for sites without access to ReSure® (p=0.01). Overall, the results of the study demonstrated there was no clinically or statistically significant difference in the incidence of endophthalmitis within 30 days of any cataract surgery between cohorts with and without access to ReSure® Sealant.
Ocular plans to submit a PMA supplement to modify the existing ReSure label to reflect the findings from the recently completed study.
ReSure® Sealant, a hydrogel ophthalmic wound sealing medical device, is a product currently indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens placement in adults.
Source: Ocular Therapeutix