Medical Device may restore visual function for patients with keratoconus and could defer the need for corneal transplant for moderate to severe keratoconus
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. Keratoconus causes a progressive thinning of the cornea and 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 keratoconus, and the fact that no other treatment options exist for patients with keratoconus 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.”
“For many of my patients, Intacs provide a solution to obtaining functional vision where contact lenses no longer suffice,” said Yaron Rabinowitz, M.D., of Cedars Sinai Medical Center in Los Angeles, Calif. “Before Intacs inserts, the only option was a corneal transplant, which I prefer to be a last resort 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.helpkeratoconus.com or call 1.800.339.2733.