It was announced today that Aldeyra Therapeutics had received a Complete Response Letter or CRL from the FDA of its drug reproxalap for the treatment of patients with dry eye disease. This was a huge blow to the biotech, because it was the second time that this drug had been rejected. I believe there must have been some confusion with the FDA in terms of what is actually required to get its drug through the finish line so that it can eventually commercialize it.
Despite this setback though, there is hope on the horizon, because as the FDA noted in the CRL, reproxalap had failed to demonstrate efficacy through severe and well-controlled studies. That’s the bad news, which of course means the company won’t be able to get this drug to patients immediately. There is still hope, because it was specified that if Aldeyra conducts one more adequate and well-controlled study targeting these dry eye disease patients, then it should be okay.
Typically, if the company had to start a new study from scratch, it would be entirely bad news. However, it is one step ahead of the game, in that it already has an ongoing dry eye disease field trial and an ongoing chamber clinical trial. It expects to announce data from both of these studies in Q2 of 2025. Should they pan out, then this will be the first step necessary to turn things around.
On the other hand, there is a second item that must be accomplished, which is that it expects an FDA Type A meeting within the next 30 days. If discussions with the U.S. agency go well, then all that will remain is the data to be released in the next several months. Such data is going to be crucial, in that if it is highly positive, then it should be in line to resubmit its New Drug Application or NDA of reproxalap to treat these dry eye disease patients by mid-2025.
Even better, if the NDA resubmission itself happens, then the review period is going to be a short 6 months. The hope is that patients get to have a drug like this to treat their disease. The reason why is because it is the only late-stage clinical topical treatment to be given in a chronic fashion. A lot of these patients could benefit from a topical treatment like this.
The company has built itself to develop its RASP-modulator platform to reduce inflammation in inflammatory disorders. Thus, the company is also developing reproxalap for the treatment of patients with allergic conjunctivitis as well. Instead of outright targeting the protein itself, it goes after the small protein-binding RASP molecules. The benefit here is being able to target a group of proteins simultaneously, instead of one at a time.
