Biotech Values

[DewDiligence]

Re: Macugen results in diabetic macular edema (DME):

Some additional color on the DME indication from today’s EYET CC:

1. The FDA’s standard efficacy endpoint for a pivotal trial in DME is the change in visual acuity from baseline measured at three years –a measurement period that two years longer than the standard one-year efficacy endpoint used for pivotal trials in AMD.

2. The possibility exists that surrogate endpoints could be used to support a DME filing using a shorter observation period than there years; however, no such surrogate endpoint has been found to date which has proven correlation to visual acuity.