Micro-thin prescription inserts cleared for keratoconus

September 10, 2004

The FDA on Aug. 5 approved a Humanitarian Device Exemption (HDE) to Addition Technology Inc. to market its micro-thin prescription inserts (Intacs) for the treatment of keratoconus.

The FDA on Aug. 5 approved a Humanitarian Device Exemption (HDE) to Addition Technology Inc. to market its micro-thin prescription inserts (Intacs) for the treatment of keratoconus.

The FDA based its decision on the safety record of the micro-thin prescription inserts; the relatively low number of U.S. patients (up to 300,000) affected by the disease; and the fact that no other treatment alternative exists for keratoconus patients other than an invasive corneal transplant procedure.

Addition Technology can now market the inserts for the reduction or elimination of myopia and astigmatism in patients with keratoconus.