Lenstec Gains FDA Approval for Softec HD™ IOL to Treat Cataracts

New Intraocular Lens Implant Enables Surgeons to Achieve Unmatched Precision and Predictability

St. Petersburg, Florida – April 5, 2010 — Lenstec, Inc. — a provider of technologically- advanced implantable lenses – today announced that the U.S. Food and Drug Administration has approved the company’s Softec HD™ Intraocular Lens Implant (IOL) for treating patients with cataracts.

The newly approved Softec HD is part of Lenstec’s “Precision Series” of implantable monofocal and accommodating IOLs that enable ophthalmologists to achieve previously unattainable precision and predictability in vision surgery.

Already approved and in use throughout the European Union, Australia, Canada, China and other international markets, the Softec HD is an aberration controlled bi-aspheric IOL designed to replace the natural crystalline lens following cataract removal in patients 21 years of age and older.

More than one million Softec IOLs have been implanted worldwide since 2005. With today’s approval announcement, cataract patients in the U.S. can now benefit from Softec HD’s advanced technology, which will be on display at the ASCRS (American Society of Cataract and Refractive Surgeons) Symposium & Congress in Boston April 9-14 (Booth # 2272).

Unrivaled Predictability

The Softec HD benefits from Lenstec’s proprietary lens manufacturing technology, which is designed to make cataract surgery more predictable by reducing the variability inherent in any manufactured lens.

When it comes to lenses used for vision correction, variability is defined as the tolerance or margin of error measured as the difference between a lens’ labeled prescription and its actual power.

With a tolerance of just 0.125D, the Softec HD reduces variability and is up to three times more precise than cataract replacement lenses manufactured under less stringent ISO standards.

“The only way to reduce lens variability is to manufacture a lens that is more precise,” said Lenstec Vice President Jim Simms. “While this requires more effort, we have been able to make the process scalable in a way that larger implantable lens manufacturers with legacy systems simply can’t match.”

Unrivaled Precision

In addition to improving predictability, Lenstec’s high-precision manufacturing process makes it possible to produce Softec HD lenses in 0.25D increments for prescriptions from +18.0D to +25D. In contrast, standard IOLs from other manufacturers are available only in 0.5D increments, which means they can be up to 0.25D out of step with a patient’s lens prescription.

“Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery,” Simms added. “Our ‘Precision Series’ technology reduces such variability and enables surgeons to more precisely target each patient’s prescription.”

William F. Maloney, M.D., associate clinical professor of ophthalmology at the University of California, Irvine, has cautioned surgeons for years about the problems associated with lens variability.

“The accuracy of the IOL prescription label is now likely to be the greatest source of refractive error in your surgery,” Dr. Maloney warned in the September 2005 issue of Ocular Surgery News. “When it comes to power, what you see is definitely not what you get. The tolerance for error in most IOL labeling is now obsolete, and it too fails today’s refractive accuracy test. Until that changes, your efforts at refractive recalibration will be hostage to this outdated industry standard.”

Simms added, “Today’s announced approval of the Softec HD means that surgeons now have the technology to address such concerns head-on and provide cataract patients with a new, vastly superior level of predictability and precision.”

Intraocular lens implants (IOLs) are used to treat cataracts – a vision disorder characterized by cloudy or opaque areas in the eye’s natural lens that usually develop gradually with advancing age (environmental factors, metabolic diseases and certain medications can also accelerate cataract formation). An estimated 2.5 million people annually in the U.S. undergo cataract surgery with an IOL implant, and an estimated 10-15 million IOLs are implanted worldwide each year.

About Lenstec Lenstec is a leading designer and manufacturer of intraocular lenses (IOLs) to treat patients with a range of vision disorders. The company’s “Precision Series” includes the Softec HD™ mono-focal Bi-Aspheric lens and the Tetraflex™ presbyopic accommodating lens, which is designed to provide cataract and presbyopia patients with clear near, intermediate and far vision. Founded in 1992, Lenstec is dedicated to advancing possibilities for ophthalmic surgeons and their patients worldwide.