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US FDA approves Alcon's new lens for cataracts with presbyopia
Huenenberg, Switzerland | Tuesday, December 30, 2008, 08:00 Hrs  [IST]

Alcon, Inc, the world's leader in eye care and cataract surgery announced that the US Food and Drug Administration (FDA) approved its +3.0 diopter add power AcrySof IQ ReSTOR IOL.

This new lens, which was introduced in many major markets outside the United States earlier this year, is now approved in the US for cataract surgery in patients with presbyopia. This lens is another technology advancement for the AcrySof IQ ReSTOR platform, which has been the number one choice of surgeons to correct presbyopia in cataract patients since it was introduced in 2005.

"The introduction of this lens allows me to deliver a full range of quality vision for my patients' needs, lifestyles and personal preferences. 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," said study investigator, Kerry Solomon, M.D., Professor of Ophthalmology, Medical University of South Carolina and Medical Director at the Storm Eye Institute. "In addition, the lens does so with the same accurate and predictable outcomes I have come to expect from the AcrySof IQ lens platform."

The US clinical trials included a three-month follow-up exam of near, intermediate and distance visual acuities. The percentage of patients who achieved 20/20 or better at all three distances with the AcrySof IQ ReSTOR +3.0 D was nearly fourfold the rate of patients who received the control lens, AcrySof IQ ReSTOR +4.0 D. The clinical studies also showed a high rate of patient satisfaction with over 95 per cent of patients stating that they would have this lens implanted again.

"Advanced technology IOLs that correct for presbyopia and astigmatism are the fastest growing IOL segment of cataract surgery. 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," said Kevin Buehler, senior vice president, global markets and chief marketing officer.

Alcon is the world's leading eye care company, with sales of approximately $5.6 billion in 2007.

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