April 8 An implantable lens designed by Bausch &
Lomb Inc to reduce vision distortion as well as
allow patients to focus on near and distant objects was safe and
effective, advisers to the U.S. health regulator said.
The Ophthalmic Devices Panel of the Medical Devices Advisory
Committee voted 10-to-none that the company's Trulign Toric
Accommodating Posterior Chamber Intraocular Lens was safe.
The lens - designed to move inside the eye - allows patient
to focus on near, intermediate and distant objects without using
spectacles after cataract surgeries.
Toric lenses are intended to correct astigmatism, or blurry
vision caused when the cornea is oblong instead of being round.
Bausch's Trulign, if approved, would be the first
implantable lens to correct astigmatism while allowing patients
to automatically focus on objects.
FDA reviewers had earlier said the study had 401 protocol
deviations - 24 of which impacted data analysis - which could
cast doubt on the study's ability to demonstrate that the
benefit from the lens outweighed the risk.
However, the 12-member panel on Monday voted 10-1 to say the
benefits of the lens outweighed the risks.
Bausch & Lomb already has an implantable lens in the market
which uses the eye muscles to focus on objects.
STAAR Surgical Co and Novartis' unit
Alcon market implantable lenses that correct astigmatism after
The clinical study for the lens included 229 patients, 227
of whom received a lens implant in one eye.