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25 Apr 2015

FDA approves first-of-its-kind corneal implant

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The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.

Presbyopia is the loss of the ability to change the focusing power of the eye. It occurs with normal aging and results in difficulty with near vision, generally in adults 40 to 50 years of age. The KAMRA inlay is an opaque, ring-shaped device intended for use in patients 45 to 60 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers.

The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.

The KAMRA inlay is manufactured by AcuFocus Inc., based in Irvine, California.

For understanding more about the product visit http://kamra.com

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