FDA panel votes to recommend Trulign toric accommodating IOL as safe, effective

In response to concerns about product labeling, a clinician representing the sponsor cited existing evidence of true accommodation with the Crystalens IOL.

Issue: May 25, 2013

GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration recently voted to affirm the safety and efficacy of the Trulign toric accommodating posterior chamber IOL.

The Trulign IOL is a toric model of Bausch + Lomb’s Crystalens AT-50SE and AT-52SE models.

During panel discussions before the April 8 vote, 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 for the lens according to a more stringent definition of accommodation.

In a closing statement, consulting representative Mark Packer, MD, said that a clinical trial on the Trulign IOL was not designed to assess the presence or degree of accommodation.

“The FDA asked some very pointed questions of the panel regarding whether or not this study proved that this lens is actually accommodating. And, of course, this study did not. It was not designed to do that. It doesn’t have any evidence in it that could form that basis of support,” Packer said in a subsequent interview with Ocular Surgery News.

Mark Packer

Packer said that he and colleagues cited existing literature supporting Bausch + Lomb’s claim of accommodation.

“There have been a number of publications in the literature looking at lens movement with ultrasound biomicroscopy or partial coherence interferometry. The results from these studies have varied. The preponderance of them, though, does show accommodative movement of the Crystalens,” Packer said.

Clinical data also support the IOL’s capacity for accommodation, he said.

“There have been more than eight studies that have relied primarily on clinical data looking at uncorrected or distance corrected, intermediate and near vision. Those have uniformly shown an advantage for the Crystalens over a standard monofocal. That’s not objective, but it’s subjective evidence,” Packer said.

Packer also said that national standards on accommodation, although evolving, have not been finalized.

Votes on safety, efficacy

The Ophthalmic Devices Panel cast 10 votes yes, zero votes no and two abstentions on the question of whether there was reasonable assurance that the Trulign toric was safe for use in patients who met the criteria specified in the proposed indication.

The panel voted 10 yes and one no, with one abstention, on the question of whether there was a reasonable assurance that the Trulign toric was effective for use in patients who met the criteria specified in the proposed indication.

When asked if the benefits of the Trulign for use in patients who met the criteria specified in the proposed indication outweighed the risks, there were 10 votes yes, one vote no and one abstention.

Panel members also voiced concerns about the overall study design, outcome measurements and high number of protocol deviations.

Rotational stability

The Trulign IOL is identical to the conventional Crystalens except that it has a toric optic on the posterior surface and marks on the front of the lens that aid aligment with the intended axis, Packer said.

Bausch + Lomb sponsored a pivotal prospective, multicenter, single-masked, partially randomized, partially controlled study on monocular implantation of the Trulign toric with follow-up based on the establishment of rotational stability up to 6 months postoperatively.

Study results showed that the Trulign IOL offered optimal rotational stability, Packer said.

“We know that this lens remains exactly where it is put in the bag in terms of rotation because of the polyimide loops that are at the tips of the haptics. It does not rotate at all. In fact, it can be difficult to rotate, which is a good thing for a toric lens,” Packer said.

Study results showed that after 6 months, mean rotation from target was less than 5°, and mean rotation between visits was less than 2°, Packer said. – by Matt Hasson and David W. Mullin

References:

U.S. Food and Drug Administration. Panel Questions for the Trulign toric accommodating posterior chamber IOL. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM346403.pdf.
U.S. Food and Drug Administration. Summary of Ophthalmic Devices Panel Meeting, April 8, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM347416.pdf.

For more information:

Mark Packer, MD, can be reached at Mark Packer Consulting Services, Inc., 4075 Southpointe Drive, Eugene, OR 97405; 541-915-0291; fax: 888-840-9392; email: mark@markpackerconsulting.com.
Disclosure: Packer is a consultant for Bausch + Lomb.