Earlier this month, ALPHAEON Corporation (a subsidiary of Strathspey Crown Holdings), obtained FDA approval for their Investigational New Drug, essentially granting the company permission to conduct clinical studies of EVOSYAL, a Botulinum Toxin (BTX) product. As it stands, the US aesthetic market for BTX is fairly consolidated most readers probably recognize the name BOTOX, but fewer may realize that it refers to a specific brand of BTX (specifically, pharma giant Allergan's BTX product)with a grand total of three companies offering products that are FDA-approved for aesthetic indications. The name BOTOX is often used interchangeably to refer to BTX products en masse, much the same way that Kleenex is synonymous with facial tissue. Allergan had first-to-market advantage when it entered the space, thereby creating a solution to a beauty problem that most (women) probably didn't realize they suffered from the so-called dreaded elevens between the brows.
Fast forward over a dozen years, and, by and large, having a BTX (or other dermal filler) procedure done is nothing to bat an eyelash at. In fact, more men and very young women are jumping on the bandwagon in the seemingly endless pursuit of agelessness.
So, what does the potential approval of EVOSYAL mean for the BTX market? Well, for one, it would mean increased competition in a space where few competitors currently operate. Assuming ALPHAEON Corporation is able to prove noninferiority against their competitors products, the entrance of a fourth competitor into the US BTX space would invariably force sales reps to vie for physicians? dollars by offering deep discounts and free samples of their products. In turn, physicians could pass on the savings to their patients by reducing the cost of the procedure, thus making it even more accessible (and affordable!) than ever before.
Is this a good thing? For certain manufacturers, sure. For the smaller players, increased competition could mean a chance to steal some market share from Allergan. In terms of increasing the accessibility to the procedure, no, I do not think it is a good thing. Our culture is already hyper-focused on aesthetics to the point where teenagers (!!) are having BTX procedures. Complications with excessive BTX usage abound, from developing resistance to the drug, to impairing a person's ability to interpret emotion and facial cues. While beyond the scope of this post, a culture obsessed with halting the (completely natural) aging process is problematic for a variety of reasons, not least of which the increasing preponderance to judge a person's worth based on their looks alone. And that just isn't right.