Biotech Values

[DewDiligence]

>> Don't they offer the placebo group the drug afterwards? Or is it too late. I know AMD can work fast. My Dad's eye went in two weeks. <<

It depends to a great extent on the disease subtype. As a rule, predominantly-classic AMD progressese rapidly, occult AMD more slowly, and minimally-classic AMD somewhere in between.

For a study lasting 6 months or more, however, patients assigned to a placebo arm are not likely to be in great shape when the main portion of the study ends and the “crossover” portion begins.

Now that Visudyne will soon be reimbursable in the U.S. for a greater subset of wet AMD than it was previously, there is a pretty good chance that a randomized phase-2b trial of Squalamine will include some provision for Visudyne in the control arm, and that should help ameliorate the enrollment disincentive of a randomized trial to some degree.