As long as I’m on the topic I got to thinking, do we really need another topical antihistamine drop? It’s a good time to ask because the rabble rousers at Eyevance have kicked their disruptive business model into high gear with the announcement of the Zerviate launch. As an aside, their answer to “do we need another topical steroid drop?” is the return of Tobradex ST.
So how about another branded topical antihistamine? We have a plethora* of prescription-only options now, both branded and generic, as well as the great over-the-counter complicator Zaditor. This is another example of a seemingly simple science question that is actually much more complex when we try to apply “best practices” in the clinic. Why don’t we start off looking at Zerviate in relation to our other options in theory before we wade into the pharmacy benefit manager-infested swamp.
Mast cell stabilizers (eg, Crolom) were once all we had to directly treat ocular allergy symptoms. They certainly work for chronic, ongoing symptoms. The challenge, of course, is that this entire class does precisely nothing for the acute symptoms of our patients. If you only prescribe a mast cell stabilizer, chances are your patient will be long gone before they begin to feel any better. H1-receptor inhibitors and combination medications (eg, Elestat, Pazeo, Bepreve, et al) are much more effective in treating acute symptoms. They are also safe to use chronically. Elestat and Bepreve tend to cause less dryness, and Bepreve has the added advantage of reducing some nasal symptoms as well. (Note to Bausch + Lomb: Almost no one knows this.)
Why another one then? Why Zerviate? As these drugs go, Zerviate knocked the cover off the phase 3 ball, achieving both its primary endpoint (conjunctival redness at 15 minutes and 8 hours) and all of its secondary endpoints (chemosis, lid swelling, episcleral and ciliary redness, and nasal symptoms). It was extremely well-tolerated (rated comfortable to very comfortable) and had no serious or severe adverse events. Fast, effective and safe. Pretty much a walk-off homer.
So do we need it? Listen, the other drops on the market are really pretty darned good; when you can get them into the hands (and eyes) of your patients, they respond very nicely, thank you very much. But that’s the problem, isn’t it? Getting them into your patients’ hands. Zerviate looks like it’s gonna be killer good, but if it was coming from traditional big pharma into the PBM-driven world, I’d say “why bother?” One more effective medicine effectively blocked from being used.
The bottom line is this: We need a medicine we can actually use. Zerviate is at least as good as everything else out there, and it may actually be just a little bit better. As I noted at the outset, Zerviate is carried by Eyevance. This is the same company that found a forgotten little gem called Flarex in the back of a linen closet at Alcon and sells it for St. Elsewhere-era prices. I have no idea what they plan to do with Zerviate, but a top-of-class topical antihistamine with access that is reminiscent of the ’90s?
Yeah, we need that.
*Uh-huh, “plethora” in an eye blog. Right?!
Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model. www.ncbi.nlm.nih.gov/pmc/articles/PMC6296187/.
Disclosure: White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.