Bausch + Lomb secured the blessing of the FDA's Ophthalmic Devices Panel on Monday, winning a 10-1 recommendation to approve the company's Trulign Toric eye implant.
The 12-member panel also voted 10-0 that the device is safe, Reuters reports, giving Bausch a solid chance to win full approval for its first-of-its-kind implant designed to repair vision after cataract surgery. The panel's vote doesn't necessarily guarantee a speedy pass through the FDA, though, and Bausch isn't disclosing when it expects to win approval for Trulign.
"While we recognize that the FDA is not obligated to follow the recommendation of the panel, we plan to work diligently with the agency to enable them to complete their review and issue an approval of our Trulign Toric accommodating intraocular lens application," the company said in a statement provided to FierceMedicalDevices.
The lens is inserted into the capsular bag of the eye to correct problems stemming from cataract removal, restoring vision without spectacles, Bausch says. In a study of 229 patients, Trulign improved visual acuity with low rates of adverse events, meeting its safety and efficacy endpoints.
The agency had previously taken issue with some of Bausch's study methodology, questioning whether the device was effective enough to merit the indications the company wants and suggesting a wide post-approval study if Trulign wins a full FDA nod. But Bausch's data were apparently enough to convince the panel, which noted that the device's benefits outweigh its risks.
Meanwhile, Bausch is ensnared in an M&A back-and-forth, as private equity owner Warburg Pincus has its eye on an IPO for the eye care giant after reportedly striking out in its effort to sell Bausch for $10 billion to the likes of Abbott Laboratories ($ABT) and Johnson & Johnson ($JNJ).
- read Bausch's statement
- read the Reuters story