FDA Approves Abbott's Intraocular Lenses For Cataracts, Astigmatism
By Jof Enriquez,
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Abbott Medical Optics recently received pre-market approval for its Tecnis Symfony, the first intraocular lens (IOL) that provides patients with an extended depth-of-focus following cataract surgery. The company also gained approval for a version of the lens to treat corneal astigmatism.
A cataract is a clouding of the natural lens of the eye, and affects some 20 percent of Americans by age 65. By age 80, more than half of Americans either have a cataract or have had cataract surgery, which involves replacing the clouded lens typically with a monofocal lens. This type of lens allows the patient to see far objects clearly, but near vision is out of focus. In contrast, Abbott's Symfony IOL's optical features extends to the full range of continuous high-quality vision at near, intermediate, and far distances. This reduces the need to wear contact lenses or glasses.
"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," said Eric D. Donnenfeld, M.D., of Ophthalmic Consultants of Long Island, New York, in a press release. "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."
The FDA approval was backed by results of a prospective, multicenter, randomized U.S. clinical trial, which showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL.
"Many people with cataracts are asking for an option that will help them perform near activities like reading, use their computers and tablets at intermediate distance, as well as see objects that are far away," stated Jason Jones, M.D., of Jones Eye Clinic in Sioux City, Iowa, an investigator on the study. "The data from this study showed that patients who received the Symfony lens were more likely to achieve improved intermediate and near vision, while maintaining similar distance vision compared with patients who received a standard IOL."
According to Abbott, other studies involving "over 2,000 eyes" showed that the Symfony lens provided seamless day-to-night vision, successful correction of chromatic aberration, and a low incidence of halo and glare.
“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, in an announcement. “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.”
The Tecnis Symfony IOL is approved in more than 50 countries, and is also available in four toric models, which are indicated for the reduction of residual refractive astigmatism or imperfections in the curvature of the eye.