Bausch + Lomb Seeks PMA for Eye Implant

According to FDA staff notes, Bausch + Lomb (Rochester, NY) is seeking approval for its new eye implant for patients who have undergone cataract surgery. The company will argue for approval of the novel implant at an FDA Ophthalmic Devices Panel next Monday.The new device, dubbed the Trulign Toric, is a multi-piece implant featuring an intraocular lens. The device is designed for insertion into the capsular bag of a patient's eye for the correction of issues caused by cataract removal. According to the company, the device can be used to restore a patient's vision without the need for spectacles.In one study involving 229 cataract surgery patients, the company stated that the device met all the efficacy and safety endpoints and was able to improve patient vision with a minimal number of adverse events.At the upcoming panel, the company will probably be questioned on if the device is adequately effective to justify the indications that Bausch + Lomb proposed. The agency is also likely to request a plan for a post-approval study of the device if it does receive approval for its PMA. A positive vote from the FDA panel does not ensure full approval from the FDA itself.