FDA Approves Hyperopia Application For The MEL 80 Excimer Laser From Carl Zeiss Meditec

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 01 Apr 2011 - 1:00 PDT


Carl Zeiss Meditec, Inc. announced that the MEL 80™ Excimer Laser has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the treatment of hyperopia. This new indication complements the existing FDA approved applications of the surgical laser for myopia and astigmatism.

"The MEL 80 combines premium optics with advanced excimer laser technology," said Ludwin Monz, president and chief executive officer of Carl Zeiss Meditec AG. "Adding the hyperopia indication enables us to offer a complete range of treatment options to meet the demands of refractive surgeons and their patients."

More commonly known as farsightedness, hyperopia makes it difficult for a patient to focus on near objects. "Hyperopia has always been a more difficult problem to treat with laser surgery," said Dr. Jon Dishler of Greenwood Village, CO. "Now with the MEL 80, the task is easier and more precise. Going forward, I would not attempt LASIK on my hyperopic patients without the MEL 80."

Clinical Results

The MEL 80 study for hyperopia included 189 patients age 22 to 69 years old, with a mean age of 47 years. A total of 369 eyes were treated. After 12 months, 148 patients, or 96.7 percent, showed uncorrected visual acuity of 20/40 or better. The results of the study were presented at the annual meeting of the American Society of Cataract and Refractive Surgery in San Diego on March 27.

FDA Indication

The MEL 80 Excimer Laser is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of > +0.5 D and < +3.0 D, with a maximum MRSE of +5.0 D, in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of < 0.5 D.

Source: Carl Zeiss Meditec, Inc

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