FDA Approves Alcon’s AcrySof® ReSTOR® Intraocular Lens
FORT WORTH, Texas – March 23, 2005
Alcon, Inc. (NYSE: ACL), announced today that the U.S. Food and Drug Administration (FDA) has granted approval of its AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery. The clinical studies supporting the approval showed that 80 percent of patients who received the AcrySof® ReSTOR® lens did not use glasses for any activities after cataract surgery.
The clinical results also showed that 84 percent of patients who received the AcrySof® ReSTOR® lens in both eyes achieved distance visual acuity of 20/25 or better and near visual acuity of 20/32 or better without correction by contacts or glasses while only 23 percent of the conventional or monofocal control group achieved this level. Near visual acuity of 20/32, or J2, means patients can read the very small stock quotes in the newspaper.
“Approval of the AcrySof® ReSTOR® lens is a significant event for Alcon that validates the extensive development work we have done to make it the best lens possible for all of a patient’s vision needs. We expect AcrySof® ReSTOR® to be a contributor to our growth in the coming years,” said Cary Rayment, president and chief executive officer, of Alcon, Inc.
Clinical investigators and other surgeons will make several presentations on the AcrySof® ReSTOR® lens in conjunction with the annual meeting of the American Society of Cataract and Refractive Surgeons in Washington, D.C. next month. The company will begin training surgeons on the lens in April and expects U.S. commercial shipments to begin in May.
Alcon, Inc. is the world’s leading eye care company with sales exceeding $3.9 billion in 2004. Global sales of its intraocular lenses, primarily the AcrySof® family of lenses, totaled more than $580 million in 2004. The AcrySof® brand of IOLs is the most frequently implanted lens in the world, with more than 21 million implants since its introduction in the early 1990s. Alcon, which has been dedicated to the ophthalmic industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. For more information on Alcon, Inc., visit the company’s web site at www.alconinc.com.
