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Thursday, 11/13/2003 8:30:10 PM

Thursday, November 13, 2003 8:30:10 PM

Post# of 252455
Alcon launches large Retaane studies in dry AMD:

http://biz.yahoo.com/prnews/031113/dath065_1.html

[Reposted from Yahoo board]:

Dry AMD is an enormous potential market. But even if these new studies go well, it will be at least six years before Retaane can be on the market for this indication. (Enrollment starts early 2004; enrollment ends mid-2004; 4 years of follow-up continues to mid 2008; NDA late 2008; FDA decision mid 2009; product launch late 2009.)

Assuming Retaane is approved for predominantly-classic *wet* AMD by mid/late 2005 (as Alcon expects), there could be some off-label use in dry AMD. However, I would not expect much off-label use because there probably won’t be reimbursement for dry AMD until there is compelling clinical data.

Kudos to Alcon for daring to enroll 2,500 patients in a brand new indication (presumably justified on the basis of strong data in primates). There are probably only two or three companies which would be willing to make that kind of commitment.


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