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FDA Ophthalmic Devices Panel calls Trulign toric accommodating IOL safe, effective
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GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration voted positively on the Trulign toric accommodating posterior chamber IOL.
The Trulign IOL is a toric model of Bausch + Lomb’s Crystalens models AT-50SE and AT-52SE.
To the question, is there reasonable assurance that the Trulign toric is safe for use in patients who meet the criteria specified in the proposed indication, there were 10 yes votes, zero no votes and two abstentions.
On the question of whether there is a reasonable assurance that the Trulign toric is effective for use in patients who meet the criteria specified in the proposed indication, there were 10 yes votes, one no vote and one abstention.
Asked if the benefits of the Trulign for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication, there were 10 yes votes, one no vote and one abstention.
“We are pleased and encouraged by the outcome of the April 8 FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee,” Elizabeth Murphy, Bausch + Lomb spokesperson, told Ocular Surgery News. “While we recognize that the FDA is not obligated to follow the recommendation of the panel, we plan to work diligently with the agency to enable them to complete their review and issue an approval of our Trulign toric accommodating IOL application.”
During panel discussions, a vocal minority of members expressed a strong opinion that post-market studies should be performed to more precisely determine the amount of accommodation and that the FDA should consider possible label changes of the lens according to a more stringent definition of accommodation.
The pivotal study was a prospective, multicenter, single-masked, partially randomized, partially controlled, monocular implantation with follow-up based on establishment of rotational stability up to 1 year postoperatively.
Panel members raised issues with the overall study design, outcome measurements and high number of protocol deviations. The FDA analysis of the trial found 28 major deviations and 373 minor deviations. Of the major deviations, 11 failed to meet enrollment criteria, seven were noncompliant with the surgical protocol, and 10 involved implantation of the AT-52T and AT-52SE IOLs instead of the AT-50T and AT-50SE models.
Perspective
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Mark Packer, MD
The FDA Ophthalmic Devices Panel voted overwhelmingly to support the safety, effectiveness and favorable risk/benefit ratio of the Trulign Toric Accommodative Intraocular Lens (Bausch + Lomb). The Trulign IOL incorporates a toric optic on the posterior surface of the parent platform accommodative IOL, the Crystalens, which was approved by FDA in 2003. The clinical investigation of the Trulign demonstrated outstanding rotational stability with mean misalignment from target of less than five degrees at 6 months postop. Mean postop refractive cylinder was less than 0.5 D for all toric powers (1.25 D, 2.00 D and 2.75 D). Mean distance corrected intermediate vision of 20/20 and distance corrected near vision of 20/40 supported the original claim for approximately 1 D of accommodation. The Trulign represents a valuable new option for Crystalens candidates because it will reduce the necessity of additional surgical procedures such as LRI's and LASIK to correct residual astigmatism.
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