An FDA advisory panel agreed today to recommend that the federal watchdog agency approve Bausch + Lomb’s first-of-a-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.
The panel voted 10-0 with 2 abstentions that Bausch + Lomb proved the Trulign Toric posterior chamber intraocular lens is safe; 10-1 with 1 abstention that the device is effective; and 10-1 with 1 abstention that its benefits outweight its risks.
The Trulign Toric lens is intended for implantation in the capsular bag of the eye in adult patients to visually correct aphakia and postoperative refractive astigmatism, according to the FDA.
"Trulign Toric provides approximately 1 diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles," according to the agency.
Only 1 accommodating intraocular lens platform comprised of several models of the Crystalens Accommodating Posterior Chamber intraocular lens has been approved to date, according to the FDA. So far, no intraocular lenses designed to provide both accommodation and correction for astigmatism, as Trulign Toric promises to do, have been approved.
Trulign Toric is a modification to the currently approved Crystalens Five-O IOL, with the only difference being that Trulign is an incorporated toroidal posterior optic surface, according to the agency.
In comments released prior to the meeting, the FDA underscored several postmarket issues for Trulign Toric. Premarket performance data for the lens does not reflect real-world device experience due to highly selected centers and study population and additional real-world performance data is needed, including device safety, long-term performance and the evaluation of performance in sub-groups, the agency said.
With those concerns in mind, FDA asked its Opthalmic Devices Panel today to discuss whether there is a need for postmarket evaluation of the real-world device performance, including whether the following are appropriate: the company’s study question and design, safety and effectiveness endpoints and length of follow-up for long-term evaluation. Also, the agency asked the panel to discuss whether there is a need for evaluation of performance in subgroups.
