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BLOG: Cequa sees the sun: A branded cyclosporine A joins the fray
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And just like that, we have two. Two non-preserved cyclosporine A drops for dry eye disease, that is. Last week Sun announced that its version received premarket approval from the FDA. About two weeks ago people started talking about Mylan and its pending application with the FDA for a generic version of Restasis. In the blink of an eye, we have gone from the mano-a-mano battle between Restasis (Allergan) and Xiidra (Shire/Takeda) into a DED treatment Thunderdome.
In my annual post-Labor Day review of the anti-inflammatory market, I will try to bring some sense to this rumble, but today let’s give Cequa its moment in the Sun (Huh? Huh?). Cequa is non-preserved 0.09% cyclosporine A, which comes in a classic dropperette. The magic here is the delivery. Sun is using a unique, first-in-class vehicle in which the cyclosporine molecules are surrounded by tiny structures called “micelles.” This micelle encapsulation allows for greater tissue penetration, while at the same time providing for what looks like a kind, gentle side effect profile. A deep reading of publicly available study data shows that the vehicle appears to provide a mild benefit as well.
Cequa will be a BID drop. FDA trial data suggest that we may see beneficial effects in as little as 2 to 4 weeks. On-label use of the “bullets” is one time and discard. You can expect a fill level similar to Xiidra, five drops or so. The math is the same as it has been forever; you know what to do. I have yet to experience the dropperettes or the medicine; I promise to report back once I have.
We are about to have as many as five cyclosporine A options in the marketplace. Will the generics be effective? Meh, your guess is as good as anyone’s at this stage. Given the historic challenges of making a topical formulation of cyclosporine, I’m not terribly optimistic. I am certainly expecting the same sort of shenanigans from the insurance companies and pharmacy benefit managers we’ve all come to expect, though, which is a bummer. It would be so much better if we could see a pure Restasis vs. Cequa cage match, you know? Who’s your pick to play the Tina Turner role?
Congratulations to Jerry St. Peter, Jason Werner, Jason Menzo and the rest of the original cast of characters at Sun who got this ball rolling. Tip o’ the hat to Brent Jones and Sanjay Malieckal for shepherding the product to the starting line in time for Mark Hagler, Ryan Bleeks and Drew Parks to get into the race. Cequa was likely worth the wait.
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.