Eyetech Eye Drug

Eyetech Pharmaceuticals Inc. (EYET.O: Quote, Profile, Research) said trading in its common stock was halted on Friday before a U.S. advisory panel meets to review its experimental drug to stop vision loss in elderly patients. A panel of outside experts that advises the Food and Drug Administration will review the drug, called Macugen, which is injected into the eye to treat age-related macular degeneration, a disease that destroys all eyesight except peripheral vision. Eyetech and Pfizer Inc. (PFE.N: Quote, Profile, Research) are developing the medicine, informs Reuter. Nasdaq - commentary - research) was halted for most of the day Friday because of a Food and Drug Administration advisory committee meeting to review the small, New York-based biotech's experimental eye disease drug. The panel meeting follows a staff report by the FDA Thursday that concluded the company's drug Macugen, has "a favorable safety profile and is an effective treatment." Eyetech is collaborating with Pfizer (PFE:NYSE - commentary - research), the world's largest drugmaker, whose stock was not halted. In a brief statement late Friday afternoon, Eyetech said the panel did not take a formal vote, "in accordance with the rolling submission process." The company provided no further information on the meeting, but said it and Pfizer were "pleased to have the opportunity to meet with the FDA and its advisory committee and look forward to further dialogue with the agency Eyetech added $1.66 to $40.60 when shares finally opened for trading late in the session. Shares jumped more than 11% Thursday in heavy volume -- about 12 times their daily average of about 574,000 shares. The disease -- called wet age-related macular degeneration (AMD) -- distorts, diminishes and destroys eyesight. Tests of the drug Macugen suggest greater hope in retarding the progress of a disease for which the few current treatments are often meager, expensive and impermanent. The staff report also says the panel should ask several key questions when reviewing Macugen. Most importantly, it said the experts should determine if sufficient data has been submitted. It also says the panel should decide if additional analyses of current data are needed. A favorable opinion by an FDA advisory committee doesn't guarantee approval by the full agency, but the FDA usually follows the advice of its advisors. As its name clearly states, the biggest cause of wet age-related macular degeneration is advancing age. It is the "single leading cause of irreversible severe vision loss in developed countries," the FDA report says." [Wet AMD] "remains an area of high unmet medical need and is a major public health issue in an aging population." The disease affects an estimated 1.6 million Americans and is growing at about 200,000 U.S. patients per year, reports the Street. According to Forbes, Biotech company Eyetech Pharmaceuticals Inc. said it is optimistic about the Food and Drug Administration's advisory panel review for its age-related blindness treatment Macugen. "The meeting couldn't have gone better," said Eyetech spokeswoman Karin Hehenberger. While the panel did not formally vote to recommend or not recommend the product for approval because of its Pilot 1 priority review status, Hehenberger said the panel unanimously agreed the company did not need to provide any additional data for the FDA to make its decision on the product. Macugen is under the FDA's Pilot 1 program, under which the agency reviews pieces of a drug application within six months of submission to provide early feedback to a sponsor. The agency will decide on the application by Dec. 17. The lack of a formal vote has not stopped other companies from obtaining approval. Hehenberger noted that the ophthalmic drugs panel never cast a formal vote for QLT Inc.'s Visudyne, another treatment for age-related macular degeneration. Visudyne had second-quarter sales of $109.3 million. Novartis AG markets Visudyne. Eyetech is collaborating with Pfizer Inc. on Macugen. The treatment binds to blood vessels in the eye to prevent proteins from forming new blood vessels and causing them to leak, two contributing factors to vision loss from macular degeneration.

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