More on phase-2 trial designs:
>> has Visudyne ever been linked or indicated for having an ability to neutralize the up-regulation of VEGF by adding any substance? <<
The use of Triamcinilone as an adjunct to Visudyne is off-label, but it has nevertheless become the de facto standard treatment for Visudyne patients. Because Triamcinilone causes some unpleasant side effects of its own, it would be better for Visudyne patients if Squalamine could be substituted for Triamcinilone.
All this is in addition to whatever benefit accrues from Squalamine per se; i.e., the phase-2 Visudyne+Squalamine trial will accomplish two things:
1) Prepare for the inclusion of Visudyne in some role in the phase-3 trial designs; and
2) Lay the groundwork for a possible alternate indication for Squalamine as an adjunct therapy in Visudyne treatment. Conceivably, this indication might be approvable more quickly the “main” indication of Squalamine as a single-agent treatment.
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