Clinical Trial Updates - Ready for the Next Step
Last time I was at my clinical trial I was given good news. I was reminded our phase 3 trial would be over in the spring. Then I was told we were being held over for another three years. They want to roll us right over into a long term study. That study will provide information about what happens to people who are on their dry macular degeneration treatment for years.
Good news for dry eye treatment?
What was not said but implied was this: the treatment is working! Why else see what happens to people who are on a treatment for years unless they intend to have people on it for years? And why have people on it for years if it is not working? How do you like that logic?
Next steps for drug
So, it would appear that sometime next year, the drug I have been given for my geographic atrophy will be presented to the FDA for approval. We hear all sorts of things about the FDA these days. Some people suggest the FDA should just approve drugs and procedures that we need without requiring rigorous testing. Fortunately, that has not been the history of the organization and I, for one, am grateful.
The role of the FDA in clinical trials
The FDA’s “real” name is the Food and Drug Administration. According to Wikipedia the FDA, a subsidiary of the Department of Health and Human Services, is responsible for protecting and promoting public health through the control and supervision of, well, food and drugs and all sorts of other stuff. It is the FDA that keeps sawdust out of your breakfast cereal and makes sure the over-the-counter cough medicine will not give you seizures. These are good things.
Of course, getting good things sometimes requires us to wait. And waiting for relief from a condition such as geographic atrophy is not fun.
How much longer before there's a dry AMD treatment?
Fortunately, there is a little thing called fast-track. The study I am in was fast-tracked. There are a number of other studies trying to find treatments for age-related macular degeneration that have also been fast-tracked.
Why? Well, according to the FDA’s page on fast-tracking, fast-tracking can be approved when there is an unmet medical need. Don’t look now, but geographic atrophy does not have any treatments or cures as of this date. Sounds like an unmet need to me!
Worried about fast-tracking and safety?
But keep in mind that fast-tracking does not cut corners on the science. Cutting corners on the science is a no-no. That way you end up with things that don’t work or worse, that can harm you.
The process of fast-tracking drugs
Instead, the fast-tracking process aims to cut out delays and the bureaucratic... uh, bovine feces.
Drug developers meet with FDA people on a more regular basis. They can also submit their new drug application in sections rather than waiting and submitting the whole document for review. Better to find glitches early, my dear. In other words, fast-tracking allows good science to move to the front of the line and not have to wait.
Hope for dry eyes
So, for all you folks with dry AMD, relief is coming. 2021 is looking to be an exciting year. The FDA has heard us and is working for us. They are clearing the administrative roadblocks so the first treatments for dry age-related macular degeneration can be delivered. They are working to ensure these treatments are safe and effective. And I, for one, am grateful.
Do you find it easy to advocate for yourself?