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SynergEyes Receives FDA Clearance for Silicone Hydrogel Hybrid Contact Lenses
SynergEyes, Inc. announced that the Food and Drug Administration (FDA) has approved the company ’s application for a next generation silicone hydrogel hybrid contact lens. SynergEyes will market the new technology as two products: Duette hybrid contact lens for astigmatism and Duette Multifocal for presbyopia.

The new hybrid platform is cleared for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and non-aphakic non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00D in eyes with astigmatism up to +6.00D.

The Duette hybrid contact lens products feature a new SynergEyes-developed GP material, MaxVu and a proprietary Flex2O silicone hydrogel skirt.

“The high modulus MaxVu RGP has a Dk of 130 and class II UV blocker incorporated, while the high DK, low modulus silicone hydrogel skirt has a Dk of 84 and is 32% water. A patent-pending surface treatment, HealthyEyes, increases wettability and resists protein deposits to maximize comfort,” says Dr. Ramazan Benrashid, Vice President of Research and Development.

Duette hybrid contact lenses for astigmatism are currently available in limited release in select practices in the U.S. A nationwide launch is planned for early 2011. In addition, Duette Multifocal will be available in limited release in early 2011.