FDA advisers say Bausch & Lomb implantable lens safe ... - Health.am

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 cataract surgeries.

The clinical study for the lens included 229 patients, 227 of whom received a lens implant in one eye.

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Reuters

Provided by ArmMed Media

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