Aldeyra Therapeutics Inc (ALDX)

[Investor2014]

7thwave,

I have held a small'ish position in ALDX for about a year and keep an eye.

My (educated layman's) view on the science is positive. With regards to your question, I think the quote below from the latest investor's call sounds objectively confident.

The 0.1% arm is meant as a control against the statistically SUPERIOR 0.5% dose. Since the response was higher than anticipated with 0.5%, and presumably with a dose response curve being available, I think it is reasonable to expect to see a statistically significant response also at 0.1%.

As always only time will tell...

Todd Brady

Yes. Good morning, Adam. And thank you for the question. It's a very interesting question because there are some changes to the Phase 2b but I think they are very positive changes and they are based on discussions with the FDA. I'd say successful discussions with the FDA. The first thing I'll note is the Phase 2b for Allergic Conjunctivitis is two doses of drug. This is a standard requirement from the agency that you establish what is generally known as the minimally effective dose. So we've selected the dose we used in the last trial which was statistically superior to vehicle. And in addition a lower dose, it's 0.5% what we used prior, 0.1% is what we are using in this trial. As we said last year we did see a higher than anticipated vehicle response in the Phase 2a study that we described in February of last year. The discussions with the agency centered around what is an appropriate control and we've convinced the agency to allow us to use [ceiling] as the control such that there is no doubt that there is any interaction between the vehicle and the allergens used to stimulate the response in the eyes of the subjects. We consider this a major success we think in theory increases the odds of success in the Phase 2b. The one thing I will note, Adam, and I know you know this but if the trial, the Phase 2b trial is positive then it could emphasis on could be considered one of two pivotal trials for approval and the indication. So one possible scenario I'd say an upside scenario is an addition to the Phase 2b if positive, you would perform a Phase III subsequently and then be in a potential position to file an NDA. So I think that answers your question. There are some differences but I think they are in our favor.