Fremont, CA (August 27, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the vision correction company, said the Food and Drug Administration (FDA) has approved an application allowing the company to finish enrolling patients in the Intacs clinical trials for a wider range of myopia treatment.
Intacs corneal ring segments, the first FDA-approved non-laser option for surgically correcting nearsightedness, are now sold in the U.S. for mild myopia (-1.0 to -3.0 diopters), a condition that affects an estimated 20 million adult Americans. Intacs for very mild myopia (-0.75 to -1.0 diopter) and moderate myopia (-3.0 to -4.5 diopters) are now being evaluated in U.S. Phase III-B clinical trials.
KeraVision said it expects the last of the planned 360 patients will be enrolled in the Phase III-B clinical trial by early 2000. After completion of the patient enrollment, the company expects to apply within one year for FDA pre-market approval (PMA) to sell Intacs for these wider ranges of myopia.
If approved by the FDA for very mild and for moderate myopia, Intacs could be a treatment option for about 90 percent of Americans who wear eyeglasses and contacts for nearsightedness, according to industry estimates.
Source Site
Vision Correction Market
KeraVision estimates that over one-half of the world's population suffers
from common vision problems such as myopia, hyperopia or astigmatism. In the
United States alone, approximately 160 million people currently use eyeglasses
or contact lenses to correct these common vision problems, with over $16
billion spent on corrective eyewear products annually. It is estimated that
over 70 million people of all ages are affected by myopia.
Source Site (EDGAR): 424B1 8/12/99 (Page 21)