Abbot Earns First-Ever FDA Approval For Extended-Range-Of-Vision Intraocular Lens
Abbott has earned FDA approval for its Tecnis Symfony Intraocular Lenses for the treatment of cataracts. The approval includes the Tecnis Symfony Toric IOL, a version of the lenses that are made for people with astigmatism. Abbott’s Tecnis Symfony lenses are the first lenses to offer extended depth-of-focus, ranging across near, intermediate and far distances.
“While [intraocular lenses (IOLs)] have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, director of the division of ophthalmic and ear, nose and throat devices in the FDA’s Center for Devices and Radiological Health, in a statement. “The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances.”
Setting the device apart from other IOLs is the fact that the Tecnis Symfony lens helps patients to see at near, intermediate and far distances. The lenses “provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects,” Abbott explained. In fact, Abbott’s lenses are the first ever in the
IOL category to offer this extended depth-of-focus.As it stands currently, cataract surgery removes the natural lens and replaces it with an artificial, monofocal lens, which only allows for sight at a distance. The Tecnis Symfony lens – which is currently approved in over 50 countries in the world – fixes that issue by improving both range and quality of vision, Abbott said.
“Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances,” said Thomas Frinzi, senior vice president of Abbott’s vision business. “This is an important addition to our portfolio of lenses, as we expect many patients to choose a Symfony lens over a standard monofocal lens, given its benefits.”
The FDA explained that it based its approval on a U.S. study which compared 148 patients using the Tecnis Symfony lens with 151 patients using a Tecnis aspheric monofocal lens in 298 patients. Those with the Tecnis Symfony lens still maintained the same distance vision as those with the monofocal lens but showed improvement in intermediate and near vision.
In general those wearing the Symfony lens were “more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition” Abbott noted. Adverse events did not differ between the two groups. Abbott noted that some positives to the lenses include seamless day-to-night vision, better quality of vision and low incidence of halo and glare.
