This article is more than 5 years old. Information may no longer be current.
Intacs OK’d for treating keratoconus
Click Here to Manage Email Alerts
DES PLAINES, Ill. — Intacs corneal ring segments have been granted a humanitarian device exemption by the Food and Drug Administration for use in patients with keratoconus, the device’s manufacturer announced yesterday.
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,” Addition Technologies said in a press release. Intacs was granted the humanitarian exemption 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,” the release said.
Brian S. Boxer Wachler, MD, said in a separate press release that procedure guidelines he and colleagues published last year were adopted for the technique by the FDA. Dr. Boxer Wachler said between 1 in 1,000 and 1 in 2,000 people in the United States are affected by keratoconus.