Device may restore visual function, could defer need for corneal transplant

DES PLAINES, Ill. – Aug. 4, 2004

Addition Technology, Inc., the manufacturer of Intacs prescription inserts for surgical vision correction, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a Humanitarian Device Exemption (HDE) to market Intacs inserts for the treatment of keratoconus. The disease, which causes a progressive thinning of the cornea, affects up to 300,000 people in the United States.

The FDA approval is based on Intacs’ excellent safety record, the relatively low number of U.S. patients affected by the disease, and the fact that no other treatment options exist for these patients other than an invasive corneal transplant procedure. The approval allows Intacs inserts to be marketed for the reduction or elimination of myopia and astigmatism in patients with keratoconus, where functional vision is no longer achievable with their contact lenses or eyeglasses. In addition, Intacs inserts may defer the need for a corneal transplant for some keratoconus patients.

The FDA approval will allow Addition Technology to educate keratoconus patients about the potential advantages of Intacs inserts and is expected to help facilitate expanded health insurance coverage for the procedure in the United States.

“Keratoconus sufferers now have a new option when it comes to restoring and improving their vision,” said William M. Flynn, president and chief executive officer of Addition Technology. “Intacs inserts fill a significant gap between rigid contact lenses and corneal transplantation for these patients.”

“In the past few years my condition caused my astigmatism to increase to the point where I couldn’t wear contact lenses comfortably and my best corrected spectacle correction was deteriorating each year. Even though the morbidity risk was low, I was reluctant to consider corneal transplantation, since the convalescent period was lengthy and as an ophthalmic surgeon, I needed good binocular vision to continue to operate,” said ophthalmologist Leslie A. Eisner, M.D. of Stamford, Conn. “Intacs in my right eye has improved and stabilized my vision, allowing me to resume my normal activities without undergoing a highly invasive transplant procedure. I can now wear soft toric contact lenses comfortably and with good vision. I’m so pleased with the results that I plan to have the left eye done this winter.”

Addition Technology, Inc., a privately held company, is the manufacturer of Intacs prescription inserts, the only corneal implant approved by the FDA. Intacs inserts are also approved for distribution in Europe, Asia, and Latin American countries that include Mexico. For more information on Intacs prescription inserts, visit www.getintacs.com or call 847.297.8419.

Drs. Huang & Song at the Doheny Laser Vision Center performs the Intacs implant procedure for the treatment of keratoconus and nearsightedness.