Significant FDA Approval for PDT

Dr. Jonathan Weiss:
Hi, my name is Jonathan Weiss. I am an adjunct assistant clinical professor of dermatology at Emory University and in private practice in the Atlanta area. I'm here today to speak to you about Ameluz and its recent approval by the FDA with an expanded indication of using up to three tubes of the product for any given patient in one treatment. This is a huge advance for the use of Ameluz because there was a limited amount of area on the face or the scalp that could be covered with one tube of Ameluz, and this makes sure that our patients will receive the appropriate amount of the product to be used with the RhodoLED, or the red light therapy.

Also, it's very helpful to have this approval because some people were using three tubes off-label, and quite honestly, that could be difficult because you either had to go into some training tubes, which were meant to be used for training more providers on how to use the product, or you had to try to order it off-label, which often would not be covered by insurance companies, and this will allow for coverage for the appropriate treatment for our patients. Now, patients will be able to get treated with the appropriate amount of product in a much shorter length of time.