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Re: drbio45 post# 553

Monday, 12/08/2003 11:27:35 PM

Monday, December 08, 2003 11:27:35 PM

Post# of 257288
I, too, replied to the Forbes author:

>>
Dear Ms. Moukheiber:

Your Bull’s Eye article [December 22, 2003] left readers with the impression that the recently completed Macugen trials produced reasonably good clinical data. However, I believe it is more accurate to consider these trials a clinical failure.

The benefit-risk tradeoff is not especially compelling as only 6% of the patients in the overall patient pool gained three or more lines on their visual acuity reading (the standard threshold for a positive response), yet 2% of these patients experienced a serious adverse event such as a cataract, infection, or detached retina.

Although the Macugen data look better when viewed in terms of “stable vision” (defined as a result no worse than a loss of two lines), one would presume that Pfizer and Eyetech were hoping for much more when they entered into their lucrative licensing pact for Macugen.

The door is open for competing therapies in the wet form of macular degeneration such as Genentech's Lucentis and Genaera's Squalamine.

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