FDA
17th March 2014

FDA Panel Recommends Approval of the Visian Toric Lens

On Friday, the Visian Toric Implantable Collamer Lens (TICL) (STAAR Surgical) was recommended for approval by the Ophthalmic Devices.

FDA Panel Recommends Approval of the Visian Toric Lens

On Friday, the Visian Toric Implantable Collamer Lens (TICL) (STAAR Surgical) was recommended for approval by the Ophthalmic Devices Panel of the Medical Devices Advisory Committee of FDA.

The Visian TICL is a toric model intended for the correction of myopic astigmatism in adults age 21 to 45 years.

Three questions were posed to the panel, and the majority ruled in favor of recommending the lens with respect to each of those questions.

Five members voted yes, one no, and three abstained regarding 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.

Seven panel members voted yes, with one no, and one abstention regarding the question of the medical device’s effectiveness in patients who meet the criteria specified in the proposed indication.

Finally, six panelists voted yes and three voted no regarding the question of whether the benefits outweigh the risk of using the lens as indicated.

Nonetheless, there were still some reservations regarding this medical device.

Panel members’ concerns were generally focused on the data collected, which was described by several panel members as “sloppy” in addition to the study being described as “flawed.” Additionally, panelists were concerned with the 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; noting that he hoped the FDA post-approval study would be completed “in a more reasonable fashion.”

Despite his concerns regarding the study, Dr. Chamberlain noted that, ultimately, this kind of technology may be very beneficial as it “has tremendous promise for certain individuals.”

The FDA is not bound by the recommendation of any of its panels; however, it normally sways in that direction.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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