An FDA advisory panel agreed on April 8 to recommend approval of Bausch + Lomb’s 1st-of-its-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 Trulign Toric lens is designed for implantation in the capsular bag of the adult eye in order to correct aphakia and postoperative refractive astigmatism, according to the FDA. Bausch + Lomb claims that Trulign Toric provides "approximately 1 diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles."
"The panel generally believes, and there was no consensus on this point, that there is some evidence that this lens provides the ability for patients to see along the continuum from near to distance, but there’s no strong evidence to support the claim of 1 diopter of monocular accommodation," said panel chair Dr. Eve Higginbotham of Emory University’s School of Medicine.
The panel was torn on the question of whether the Trulign Toric is truly an "accommodating" lens, but the panel voted 10-0 with 2 abstentions that Bausch + Lomb proved the device is safe; 10-1 with 1 abstention that the device is effective; and 10-1 with 1 abstention that its benefits outweigh its risks.
"The vote of this independent panel of experts supports the view that the results of the clinical trial demonstrated that our Trulign Toric accommodating posterior chamber intraocular lens is both safe and effective for its intended use," Bausch + Lomb said in a statement released after the panel vote. "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 intraocular lens application."
Bausch + Lomb declined to comment on a planned launch date or roll-out number for the U.S. market prior to receiving actual approval from FDA.
Panelists explain their votes
Dr. Thomas Steinemann of MetroHealth Medical Center in Cleveland, Ohio, clarified why he and other panelists voted to recommend approval, even though the general agreement was that Trulign Toric "maybe" proved its claim of accommodation.
"Back to the practitioners standpoint, we face on a daily basis patients who accept this, they want this, and they’re going to get it," Steinemann said. "The question is: are we assessing this from a scientific validity standpoint, or looking at this from a truth in advertising [perspective]?"
"Are we providing a product that is living up to what we’re saying it is?" he added. "It’s an accommodating lens. I struggle with that."
To date the FDA has approved only 1 accommodating intraocular lens platform, consisting of several models of the Crystalens Accommodating Posterior Chamber intraocular lens, according to the agency. If given the green light, the Trulign Toric would be the only market-approved intraocular lens designed to provide both accommodation and correction for astigmatism.
Trulign Toric is a modification of the currently approved Crystalens Five-O IOL, with the primary difference being that Trulign incorporates a toroidal posterior optic surface, according to the agency.
"The majority of panel members believe that, despite 400 protocol deviations, there is some assurance that the benefits outweigh the risks of this lens," panel chair Higginbotham said. "However, there was a strong minority opinion that felt that it was very difficult to be sure."
Dr. Scott Evans of Harvard University’s Department of Biostatistics abstained from voting on the safety question due to a dearth of clinical experience for Trulign Toric. He voted "no" on questions of efficacy and on whether the benefits outweigh the risks, citing problems with trial quality, including many protocol deviations and unplanned group analyses.
Panel asks for rigorous postmarket follow-up
In comments released prior to the meeting, the FDA underscored several postmarket concerns for Trulign Toric. Premarket performance data for the lens doesn’t reflect real-world experiences with the device, the agency said, and more data may be necessary to evaluate device safety, long-term performance and performance in sub-groups.
The panel generally agreed that there is a need for postmarket evaluation of Trulign Toric’s real-world device performance, and they asked for a pilot study to validate Trulign Toric’s accommodation using objective measurements and following patients who have already had the lens implanted long-term.
Panelists asked for a large study to further assess vaulting adverse events – a condition that occurs when the lens optic becomes lodged in an anterior position independent of ciliary muscle relaxation or contraction (whether the patient is focused at distance or at near.)
Bausch + Lomb also reported another vaulting adverse event that may necessitate secondary surgical interventions: an asymmetric combination of capsular contraction forces and vitreous pressure may occur in the anterior vault of one hinge and the posterior vault of the other hinge, which creates an asymmetric tilt of the lens.
Panelists requested a small study to determine some of the long-term adverse events beyond 6 months.
The panel also asked for patient-reported outcomes, particularly related to satisfaction, efficacy and the binocular insertion of Trulign Toric, as well as safety data about the positioning of the lens.