Eyetech Holders Eye FDA Panel

Eyetech Pharmaceuticals (EYET) faces an important regulatory test Aug. 27 when a Food and Drug Administration advisory panel will review Macugen, the company's experimental drug intended to treat an eye disease that is one of the leading causes of blindness among older people.

As is the case with every FDA advisory committee meeting, Eyetech has a lot riding on the panel's recommendation. The company went public in January at $21 per share. Today, the stock trades around $32. Investor attention for Eyetech has been driven largely by Macugen's commercial potential -- it will be the company's first market product, if approved -- and the fact that Eyetech will co-market the drug with pharmaceutical giant (and marketing powerhouse) Pfizer(PFE).

Macugen is designed to treat the "wet form" of macular degeneration, a chronic, progressive eye disease that is the leading cause of vision loss and blindness in people over 50. In the U.S., Eyetech estimates that there are more than 1.6 million people suffering from wet macular degeneration, with approximately 200,000 new cases diagnosed every year.

Currently, Canadian drugmaker QLT(QLTI), and partner Novartis(NVS), sell the only approved treatment for wet macular degeneration, a product called Visudyne. But Visudyne, with worldwide sales of $357 million in 2003 and projected 2004 sales of $420 million, is only approved in the U.S. for classic wet macular degeneration, the smallest of the three subtypes of the disease, accounting for 25% of all cases. Eyetech is seeking Macugen approval for all three subtypes (classic, minimally classic and occult), which would give the drug a significant marketing advantage.

But of course, Eyetech has to get Macugen past FDA regulators first, which is why the Aug. 27 advisory committee, and its recommendation up or down for approval, will be so important.