Bausch + Lomb is seeking FDA approval for a first-of-its-kind eye implant designed to repair vision after cataract surgery, and the company will make its case to the agency's Ophthalmic Devices Panel on Monday.
The Trulign Toric intraocular lens is a multi-piece implant inserted into the capsular bag of the eye to correct problems stemming from cataract removal, restoring vision without spectacles, the company says. In a study of 229 patients, Bausch says the device met its safety and efficacy endpoints, improving visual acuity with low rates of adverse events.
At Monday's panel, Bausch will likely face questions over whether Trulign has proven effective enough to warrant its proposed indications, according to an FDA staff document, and the agency will want to hear a concrete plan for a post-approval study if the device ends up winning its PMA. If Trulign clears the panel with a positive vote, that won't necessarily guarantee full approval when the agency makes its final consideration.
All this comes as Bausch is caught in a will-they-won't-they M&A rumor cycle. First, the story was that Warburg Pincus, which owns the company, was trying to sell it off to the likes of Abbott Laboratories ($ABT) and Johnson & Johnson ($JNJ) for around $10 billion, but, getting no takers, the company is now said to favor an IPO for the eye care mainstay.
Bausch is well known for its consumer eye products, but the company has a stable of prescription drugs and non-OTC devices and has been steadily expanding its market share in both fields.
- read the FDA staff notes (PDF)