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Replies to #70676 on Biotech Values
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mouton29

12/27/08 12:23 AM

#70677 RE: DewDiligence #70676

<<The method of application has prevented [eyelid darkening] from happening with Latisse>>

That's not the impression I get from the package insert. Note the different language describing the possibility of iris pigmentation v. lid pigmentation. For the former, they state iris pigmentation happens with Lumigan but was not observed with Latisse, but they don't make the same statement for lid pigmentation. Also, they report some lowering of IOP, suggesting that the medication is getting onto the eye. Still, the lid darkening, unlike the iris darkening, is temporary, so you can always stop if it happens, which suggests that this may not be a significant sales issue even if it happens on occasion.

5.1 Effects on Intraocular Pressure
Bimatoprost ophthalmic solution (LUMIGAN®) lowers
intraocular pressure (IOP) when instilled directly to the
eye in patients with elevated IOP. In clinical trials, in
patients with or without elevated IOP, LATISSE™
lowered IOP, however, the magnitude of the reduction
was not cause for clinical concern.

5.2 Iris Pigmentation
Increased iris pigmentation has occurred when the same
formulation of bimatoprost ophthalmic solution
(LUMIGAN®) was instilled directly onto the eye.
Although iridal pigmentation was not reported in
clinical studies with LATISSE™, patients should be
advised about the potential for increased brown iris
pigmentation which is likely to be permanent.

5.3 Lid Pigmentation
Bimatoprost has been reported to cause pigment
changes (darkening) to periorbital pigmented tissues
and eyelashes. The pigmentation is expected to
increase as long as bimatoprost is administered, but has
been reported to be reversible upon discontinuation of
bimatoprost in most patients.



http://www.latisse.com/pdf/Latisse_ProductInformation.pdf