The FDA last week granted pre-market approval to the Tecnis Symfony intraocular lens made by Abbott Medical Optics (NYSE:ABT) for treating patients with cataracts.
The device is the 1st intra-ocular lens to provide extended depth of focus for better vision at near, intermediate and far distances, the federal safety watchdog said. Abbott said the FDA also approved a version for patients with astigmatism called the Tecnis Symfony Toric intraocular lens.
“Abbott is focused on improving people’s vision and their lives by helping them stay healthy and active. Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances,” Thomas Frinzi, senior vice president of Abbott’s vision business, said in prepared remarks. “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. We are happy that we can offer more people around the world this new category of lenses.”
“The Symfony intraocular lens is a new option I can offer my patients to improve their vision following cataract surgery, especially those who have difficulty focusing on objects at near distances because of presbyopia,” added Dr. Eric Donnenfeld of Ophthalmic Consultants of Long Island, N.Y. “Many of my patients live very active lifestyles and want to see clearly at all distances, and without glasses if possible. With the Symfony lens, I can give patients the freedom to enjoy the activities that matter to them, while wearing glasses less.”
Abbott said the Symfony device has been approved for sale in more than 50 countries. The FDA nod was based on a 298-patient study comparing it with Abbott’s Tecnis aspheric monofocal lens; the study showed that 77% of patients implanted with the Symfony device had good vision without glasses at intermediate distances, compared with 34% for the control arm. Patients in the Symfony arm were able to read 2 more lines in a standard eye chart than patients in the control arm; both cohorts showed similar results for distance vision and adverse events, the FDA said.
“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Dr. Malvina Eydelman, director of the Division of Ophthalmic & Ear, Nose & Throat Devices at the FDA’s Center for Devices & Radiological Health. “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.”