Alcon, AMO receive FDA approvals for multifocal lenses

Within the past week, both Alcon and Advanced Medical Optics have received premarket approval from the Food and Drug Administration for lenses to treat presbyopia. The companies announced the approvals in separate press releases.

Alcon received marketing approval for its AcrySof ReStor IOL, indicated for implantation in patients undergoing cataract surgery who also have presbyopia. An Alcon spokesman 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 nationwide.

According to the Alcon press release, the ReStor IOL uses “apodized diffractive technology to give patients a full range of quality vision.”

After implantation, 80% of patients in the clinical trials did not use glasses for any activities, the release said. Furthermore, 84% of patients who underwent bilateral implantation achieved distance visual acuity of 20/25 and near VA of 20/32 or better without further lens or spectacle correction. In a control group, only 23% of patients with conventional monofocal IOLs achieved that level of VA.

Surgeon training with the ReStor will begin next month, with commercial shipments to begin in May, the company said.

AMO received FDA approval for its ReZoom multifocal refractive IOL for cataract patients, the company announced this week. According to AMO, the ReZoom 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 its press release.

The ReZoom has already received the CE Mark in Europe, AMO noted.