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Alcon, AMO receive FDA approvals for presbyopia IOLs
Within hours of each other, the two lenses were approved for use in the United States.
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On the same day in March, both Alcon and Advanced Medical Optics received premarket approval from the Food and Drug Administration for IOLs to treat presbyopia.
Alcon’s AcrySof ReStor
Alcon received marketing approval for its AcrySof ReStor IOL, indicated for implantation in patients undergoing cataract surgery who also have presbyopia. An Alcon spokesperson told Ocular Surgery News that the FDA evaluated data on 566 patients with a mean age of 69 years who were implanted with the ReStor in several centers: 439 patients in the United States and 127 in the European Union. Their results were compared with 194 control eyes implanted with Alcon’s MA60BM IOL.
The ReStor is a pseudoaccommodative apodized diffractive three-piece IOL, according to company information. At last year’s American Academy of Ophthalmology meeting, Kerry Solomon, MD, said patients in the clinical trials of the lens expressed a high degree of satisfaction with tasks such as working at a computer or reading fine newspaper print.
AMO’s ReZoom
AMO received FDA approval for its ReZoom multifocal refractive IOL for cataract patients, the company announced. According to AMO, the ReZoom lens distributes light over five optical zones for enhanced restoration of visual function. The lens provides “distance, intermediate and near vision for reduced spectacle dependence,” the company said in a press release.
An AMO executive told OSN that the approval for ReZoom came 5 months earlier than anticipated.
“We were not expecting approval for ReZoom until August or September,” said Ron Bache, vice president of global refractive marketing at AMO.
The FDA approval was based on multicenter clinical trials involving more than 350 patients, the company noted.
The ReZoom had already received the CE Mark in Europe, the AMO official said, where it is approved for the treatment of presbyopia. He added that the ReZoom is an “optimized refractive design on the acrylic platform.”
For Your Information:
- Kerry D. Solomon, MD, can be reached at the Medical University of South Carolina, Storm Eye Institute, 171 Ashley Ave., Charleston, SC 29425; 843-792-8854; fax: 843-792-4854.
- Ron Bache can be reached at Advanced Medical Optics, 1700 E. St. Andrew Place, Santa Ana, CA 92799; 714-247-8300; fax: 714-247-8682.
- Advanced Medical Optics, manufacturer of the ReZoom IOL, can be reached at 1700 E. St. Andrew Place, Santa Ana, CA 92799; 800-449-3060; fax: 866-872-5635; www.amo-inc.com.
- Alcon, manufacturer of the AcrySof ReStor IOL, can be reached at 6201 South Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-6142; www.alconlabs.com.
- Michelle Dalton Liberatore is the managing editor of the OSN SuperSite.com. She writes daily updates on developments in all aspects of ophthalmology.