FDA Approves Trulign Intraocular Lens

Megan Brooks

May 22, 2013

The US Food and Drug Administration (FDA) has approved the Trulign toric posterior chamber intraocular lens (IOL) from Bausch + Lomb, the company announced yesterday.

The approval follows a favorable decision April 9 from the FDA's Ophthalmic Devices Panel.

As reported by Medscape Medical News, the panel voted that the Trulign toric IOL is safe (10 yes, 2 abstain) and effective (10 yes, 1 no, 1 abstain) and that the benefits outweigh the risks (10 yes, 1 no, 1 abstain).

In a statement, Bausch + Lomb said the Trulign toric IOL is "intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision."

In the FDA clinical trial, the Trulign toric IOL demonstrated improved uncorrected near, intermediate, and distance vision. "The unique haptic design provided superior rotational stability, with 96.1% of the lenses rotating less than 5 degrees from the day of surgery to four-to-six months after surgery," the company noted.

In the company statement, Jay Pepose, MD, PhD, of the Pepose Vision Institute in St. Louis, Missouri, and medical monitor of the FDA clinical trial, said the Trulign toric IOL is the first product that addresses "two important unmet clinical needs of cataract patients in a single procedure: One of which is offsetting substantial preexisting corneal astigmatism, which impacts over 1 in 3 patients. The other is the desire that patients express to have excellent uncorrected distance and intermediate vision with improved near vision."

"Due to advancements in the Trulign toric, there are the real-world benefits that patients will enjoy with this lens. We can offer patients a premium intraocular lens that enhances their visual acuity and can reduce the need to wear glasses for their day-to-day activities," Dr. Pepose added.

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