FDA panel recommends approval of Visian toric implantable Collamer lens, has reservations
GAITHERSBURG, Md. – The Visian toric implantable Collamer lens was recommended for approval by the Ophthalmic Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration.
The Visian toric implantable Collamer lens (TICL, STAAR Surgical) is a toric model intended for the correction of myopic astigmatism in adults age 21 to 45 years.
Majority ruled in favor of recommending the lens be approved on all three questions posed to the panel.
To the question of whether there is reasonable assurance that the Visian TICL is safe for use in patients who meet the criteria specified in the proposed indication, five members voted yes and one voted no, with three abstentions.
The question of its effectiveness in patients who meet the criteria specified in the proposed indication garnered seven yes votes and one no vote, with one abstention.
To the question of whether the benefits outweigh the risk of using the lens as indicated, six members voted yes and three voted no.
Panel members’ concerns were focused on the data collected, which was described by several panel members as “sloppy”; the study, which was described as “flawed”; and long-term effects of endothelial cell loss.
On all three questions, Winston D. Chamberlain, MD, PHD, voted yes “with trepidation” due to the way in which the study was conducted.
Ultimately, after commenting that he hoped the FDA post-approval study would be completed “in a more reasonable fashion,” Chamberlain affirmed the benefits of the Visian TICL.
“I believe this technology has tremendous promise for certain individuals,” he said.