FDA approves new ReSTOR multifocal IOL
December 23, 2008
Alcon, Inc. (Huenenberg, Switzerland) announced today that the U.S. Food and Drug Administration (FDA) has approved the company's new AcrySof IQ ReSTOR +3.0 D multifocal IOL for cataract surgery.
The new intraocular lens (IOL), which was introduced in international markets outside the United States earlier in 2008, is now approved for cataract surgery performed in the U.S. for patients with presbyopia.
Latest addition to AcrySof IQ ReSTOR multifocal IOL platform
The new ReSTOR multifocal IOL, with a +3.0 D add power for near vision, represents another technology advancement for the AcrySof IQ ReSTOR product portfolio, which was launched in 2005 and has been the number one choice of eye surgeons for the correction of presbyopia in cataract surgery since then, according to the company.
"The introduction of this lens allows me to deliver a full range of quality vision for my patients' needs, lifestyles and personal preferences," said Kerry Solomon, MD, professor of ophthalmology, Medical University of South Carolina and medical director at the Storm Eye Institute (Charleston, SC) in a press release issued by Alcon. "In my experience, the AcrySof IQ ReSTOR +3.0 D add IOL gives my patients a more comfortable reading distance, improved intermediate vision for tasks such as computer work, and excellent distance vision," he continued.
Dr. Solomon served as study investigator for the U.S. clinical trials of the new ReSTOR multifocal IOL required for FDA approval of the lens.
Results of clinical trials
The FDA clinical trials for the lens included a three-month follow-up exam, during which visual acuity was tested at distance, intermediate and near. Patients were also asked about their overall satisfaction with the new multifocal IOL.
Among the results of the study:
- The percentage of patients who achieved 20/20 vision at all three distances with the AcrySof IQ ReSTOR +3.0 D multifocal IOL was nearly four times greater than the percentage of patients who received the control lens (AcrySof IQ ReSTOR +4.0 D multifocal IOL).
- Over 95 percent of the patients receiving the new AcrySof IQ ReSTOR +3.0 D multifocal IOL were pleased with the overall performance of the lens and said they would choose to have it implanted again.
Growing demand for premium IOLs
Premium IOLs that correct presbyopia and astigmatism are the fastest-growing segment of the intraocular lens market, according to Kevin Buehler, senior vice president, global markets, and chief marketing officer at Alcon.
"The addition of this new lens meets a growing desire on the part of cataract patients for spectacle independence after cataract surgery. With the availability of the AcrySof IQ ReSTOR +3.0 D lens, surgeons can deliver true performance at all distances for their cataract patients," Buehler said.