With the FDA’s approval last week of Abbott Medical Optics’ Tecnis Symfony IOL (intraocular lens), cataract and refractive surgeons have a new alternative to monovision correction for presbyopes that they think will give the premium IOL channel a much-needed boost.
Two and a half years after scrapping plans for its Synchrony accommodating IOL in the US after it got hung up in the FDA review process, AMO has emerged as the first out of the blocks in the US with an FDA-approved extended-range-of-vision IOL. The FDA also approved four toric models of Tecnis Symfony for astigmatism.
With a monofocal IOL, people can see clearly at distance but need glasses to focus at intermediate and near ranges. Tecnis Symfony is designed to improve focus at near and intermediate ranges as well as at distance. In the clinical trial submitted with AMO’s application, 77% of the people who had the Tecnis Symfony IOL had vision of 20/25 or better without glasses at intermediate vision versus 34% of those with the monofocal IOL. As for near vision, those with the Tecnis Symfony IOL could read two additional smaller lines on the Snellen chart than those with the monofocal IOL. Distance vision was comparable for both groups.
Cataract and refractive surgeons who Eye on Innovation asked for comment seem pumped about having this option in their toolbox. Here’s what five of them said.
“The Symfony IOL has design features that enhance image quality and others that provide an expanded and continuous depth of focus,” said Jay S. Pepose, MD, PhD, of Pepose Vision Institute and professor of clinical ophthalmology at Washington University School of Medicine in St. Louis. “Because there are not two defined images cast on the retina simultaneously, the IOL has little photic phenomenon.”
“The Symfony lens is distinctly different from the currently available presbyopia-correcting implants in the US,” said Vance Thompson, MD, of Vance Thompson Vision in Sioux Falls, SD. “For instance, multifocal implants split light between near and distance focal points, which can lead to glare and halos in low-light situations. The Symfony lens has a unique diffractive echelette design feature that extends the range of vision along with achromatic technology, which reduces chromatic aberration to increase contrast sensitivity and enhance quality of vision.”
Stephen Slade, MD, of Slade & Baker Vision Center in Houston, put this approval in the context of other recent FDA approvals – Shire’s Xiidra (liftegrast) for dry eye, Revision Optics’ Raindrop corneal inlay, and Avedro’s Photrexa and KXL corneal collagen cross-linking system for keratoconus. “I am cheered by this approval and the total of four FDA approvals these past few days,” he said.
“We have used the newer low-power multifocal IOLs from AMO and Alcon and like our results. These new lenses offer us more options and that means our patients have more choices,” Dr. Slade said. “I do believe that these new lenses will grow the premium IOL space.”
“Great news on approval of the Symfony IOL, Mitchell A Jackson, MD, founder and CEO of Jacksoneye in Lake Villa, Ill. “It delivers a continuous full range of high quality vision with reduced incidence of halos and glare comparable to a traditional multifocal IOL and due to its ability to reduce chromatic aberration, it has been classified as its own type of IOL, known as extended depth of focus (EDOF) category.”
Said David R. Hardten, MD, of Minnesota Eye Consultants: “Abbott continues to advance the field of high-quality IOL choices for patients seeking improvement in their vision. The Symfony IOL will help surgeons provide another excellent alternative for improvements in vision after cataract surgery.”
The US is a latecomer to Symfony; it has been available in more than 50 other countries.