|The AcrySof IQ ReSTOR Intraocular Lens--Courtesy of Alcon|
The FDA's Ophthalmic Devices Advisory Committee panel overwhelmingly recommended PMA approval of Alcon's AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia. The FDA is not bound to follow the committees' approval decision, but usually does.
The panel voted unanimously that the intraocular lens (IOL) is safe and that the device's benefits outweigh its risks. It voted 11-1 that the device is effective in patients who meet the criteria in the proposed indication. AcrySof IQ combines the benefits of both toric IOLs for correcting astigmatisms (which occur due to an abnormally shaped cornea or lens) and multifocal IOLs for clearer vision at various distances and correction of presbyopia. The symptoms of presbyopia are similar to farsightedness, or difficulty seeing objects up close, but the two conditions are not the same, says vision care insurance provider VSP.
There are 10 approved premium IOLs on the market, including three multifocal ones, but if AcrySof IQ is approved, the device would be the first of its kind. "There is no approved multifocal IOL in the United States that corrects corneal astigmatism and provides near, intermediate, and distance vision," an FDA spokeswoman told FierceMedicalDevices in an email.
According to the FDA's executive summary, the proposed indication for use "is primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence."
All intraocular lenses are class III devices requiring PMA approval, instead of the more common and less stringent 510(k) pathway, because they are considered high-risk devices. At the meeting, Alcon, a subsidiary of Big Pharma Novartis ($NVS), presented the results of its 570-patient non-randomized clinical trial of AcrySof IQ.
"There is presently an unmet medical need for a multifocal intraocular lens that can correct for spherical error, astigmatism, and near vision in a single surgical procedure for patients desiring less dependence on spectacle correction after cataract surgery," said Dr. Stephen Lane, medical director of Associated Eye Care and adjunct clinical professor at the University of Minnesota, in a statement. "The data presented today demonstrated a favorable benefit-risk ratio that I believe will translate into an exciting new treatment option for my patients and my colleagues' patients across the US, without the requirement of additional surgical procedures."
The sole no vote came from Susan Vitale of the National Eye Institute in Bethesda, MD, who had doubts about the patient-reported outcomes related to spectacle independence, or the ability to go without glasses. "All the other evidence was quite convincing, but I don't feel quite comfortable with saying 'yes' when it includes the increased spectacle independence as one of the outcomes," she said, according to Healio.
AcrySof IQ is already approved for sale in the European Union, Australia, Canada, Japan and many other countries within Central and South America, according to the release. Alcon says international sales of the IOL exceed 93,000 units since 2010.
Editor's Note: This article has been update with additional information provided by an FDA spokeswoman.