Ocular Therapeutix has reached the final gauntlet in its quest to win FDA approval for its new eye surgery sealant. Mark your calendars for Sept. 19, when the company will appear before a panel of experts to make its case.
While panel recommendations aren't binding, they can shape the FDA's final decision. And so it is extremely important for the Bedford, MA, company to successfully argue before the Ophthalmic Devices Panel meeting that its ReSure Sealant deserves a PMA. The stakes are high. If the FDA approves ReSure, it would become the first and only product of its kind approved for the eye, and that status would carry with it some major market prowess.
Ocular filed its PMA earlier this year. If approved, clinicians could use it to close wounds from leaking corneal incisions following surgery for cataracts or intraocular lens placement. The company plans to make its case before the panel, in part, with data from a randomized, parallel-arm clinical trial involving 488 patients at 24 U.S. sites. Researchers compared ReSure to sutures 7 days after cataract surgery. As the company notes, cataract surgery is the most commonly performed surgery in the U.S., with 3.5 million procedures each year. Post-surgery wound leaks can lead to complications, however, and Ocular says its ReSure product can help counter this.
ReSure is made of a synthetic, polyethylene glycol-based hydrogel polymer. Doctors apply it as a liquid and then it becomes a gel on the surface of the eye, the company explains. After about a week, it discharges through a patient's tears.
Ocular grabbed close to $24 million in new Series D financing early this year to help advance sustained-release drug candidates travoprost and dexamethasone in its pipeline. Separately, the company is also developing plug inserts into the eye's punctum to treat glaucoma, ocular hypertension and bacterial conjunctivitis. Ocular launched in 2006 and is based in Bedford, MA.
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