With a wide array of IOL options available to their foreign colleagues, U.S. ophthalmologists eagerly await the approval and availability of additional lenses.
In 2014, U.S. cataract surgeons remained envious of the range of IOL options available to their foreign colleagues.
However, at the close of the AAO meeting in October, they were looking forward to the upcoming FDA Ophthalmic Devices Panel review of the AcrySof IQ ReSTOR Toric Multifocal IOL (Alcon Laboratories) and excited about the Tecnis Symfony Extended Range of Vision IOL (Abbott Medical Optics), which had just been released onto the European market and is being studied in an FDA trial.
Mark Packer, MD, referred to FDA panel review of the ReStor Toric IOL as the biggest IOL-related news of the year for U.S. surgeons. On Nov. 14, it was announced that the FDA’s Ophthalmic Devices Advisory Committee has recommended approval for AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens (ReSTOR Toric IOL) for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.
He anticipated an approval would not be announced until 2015. But when it comes, it will be a big deal, said Dr. Packer, who is in private practice, Boulder, CO, and clinical associate professor of ophthalmology, Oregon Health & Science University, Portland.
“To date, surgeons implanting multifocal IOLs have had to rely on corneal relaxing incisions or LASIK to address significant astigmatism. Approval of the Trulign toric accommodating IOL (Bausch + Lomb) in 2013 brought an option that certainly provides better intermediate and near vision than a monofocal toric IOL. The ReSTOR toric will be the first multifocal toric IOL in the US, and that is exciting,” he said.
Randall Olson, MD, noted that at the XXXII Congress of the ESCRS in September, there were a number of presentations reporting interesting results with a multitude of new approaches to presbyopia-correcting IOLs and continued excitement about the Rayner add-on lenses as more outcomes data were presented about that technology. However, he said that many of these technologies are unlikely to reach the U.S. market as the cost of running the regulatory juggernaut is limiting manufacturers’ interest in pursuing FDA approval.
“That is certainly a big concern for U.S. surgeons,” said Dr. Olson, professor and chairman, department of ophthalmology and visual sciences and chief executive officer, John A. Moran Eye Center, University of Utah, Salt Lake City.