Anamed Inc announced that the FDA has approved its IDE to begin a clinical trial with its PermaVision intracorneal lens for the correction of hyperopia (farsightedness) up to + 6 diopters. The company plans to open clinical sites in the fall of 2001.

"The lens is designed to offer an outstanding solution to hyperopia, especially in the higher ranges. The operation is straightforward, and LASIK surgeons already possess the necessary skills," said Dr. Stephen Slade, of the Laser Center of Houston "The PermaVision keratophakia lens also offers the advantage of being removable, an important option in today's refractive surgery environment."

The company earlier announced that it's PermaVision intracorneal lens received the CE Mark and approval for commercial distribution throughout the European Union (EU). This makes Anamed the only company with regulatory approval to commercialize intracorneal lenses.

The lens is implanted in a sutureless synthetic keratophakia procedure to correct refractive errors of the eye. While keratophakia has been under development for the past 50-plus years, it took Anamed's proprietary Nutrapore material to make the procedure viable. The Nutrapore material from which the PermaVision lenses are made mimics the properties of the stroma for water content, refractive index, optical clarity, fluid transport, and permeability of metabolites and oxygen. The micron-precisioned lenses are placed inside the cornea in a sutureless procedure to correct hyperopia (farsightedness). To implant them, a hinged flap is made in the cornea, just as in LASIK. The lens is placed under this flap and centered over the pupil. The flap is then folded back over the lens and the eye. Fluid dynamics keeps the lens and the flap in place. No stitches are necessary.

An on-going international, multi-center human clinical trial was opened in December 1999, expanded to four sites in 2000 and to 14 centers in 11 countries during 2001. In addition, the PermaVision lens has successfully completed long term porcine evaluations.

"The overall patient data indicates that the PermaVision lens can correct vision without a laser. Perhaps even more important, the flap can be lifted and the lens removed or exchanged since tissue is not ablated or destroyed" according to Professor Dr. Herbert Kaufman, Chairman of the LSU Eye Center.