Tecnis Symfony Intraocular Lens Wins FDA Approval

Disclosures

July 15, 2016

The US Food and Drug Administration (FDA) today approved a first-of-its-kind intraocular lens (IOL) for cataract treatment that provides vision at near, intermediate, and far distances as a multifocal IOL does, but with less of a halo and glare problem.

The new lens, the Tecnis Symfony IOL (Abbott Medical Optics), gives patients with cataracts "extended depth of focus" to improve visual acuity at any distance, according to an FDA news release. That's an improvement upon traditional monofocal IOLs, typically designed to improve far-distance vision at the expense of seeing things closer up.

Multifocal IOLs also enable a full range of vision, reducing the need to wear glasses or contact lenses for intermediate or near distances. However, patients with these lenses have complained about the halos and glare of night-time dysphotopsia. The Tecnis Symfony IOL reduces night-time dysphotopsia to the less bothersome level found with monofocal IOLs, according to a statement from Abbott Medical Optics.

The Tecnis Symfony IOL also provides continuous vision at all ranges without any drop-offs in between owing to its single, elongated focus, in contrast to multifocal IOLs with distinct focal points, the company said in a statement to Medscape Medical News.

"While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology," said Malvina Eydelman, MD, director of the Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health, in the agency's news release. "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 agency approved the new IOL based on a randomized clinical trial that compared 148 cataract patients implanted with the Tecnis Symfony IOL with 151 patients who received a monofocal IOL. When it came to intermediate distances, 77% of the patients with the Tecnis Symfony IOL had 20/25 vision compared with 34% in the monofocal IOL arm of the study. For near distance, the Tecnis patients could read two additional, progressively smaller lines on a standard eye chart, compared with patients who received the monofocal IOL. Both groups scored roughly the same on far-distance vision.

Adverse events observed in the trial included worsened or blurred vision, bleeding, and infection. The new IOL may reduce contrast sensitivity, especially in conditions of poor visibility such as fog or dim light, the FDA said. Visual halos, glare, or starbursts also may occur.

Approved in more than 50 countries, the Tecnis Symfony IOL comes in four toric models designed to correct residual refractive astigmatism or imperfections in eye curvature, according to the company statement.

More information about today's announcement is available on the FDA website.

 

 

Follow Robert Lowes on Twitter @LowesRobert.

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