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Restasis and bioequivalence
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We interrupt this well-designed linear discussion of dry eye syndrome to bring you an important announcement: Allergan has challenged the U.S. Food and Drug Administration in support of Restasis.
You are probably thinking something along the lines of, “Duh, of course it is,” because Restasis (cyclosporine ophthalmic emulsion 0.05%) is about to lose patent protection, but openly challenging the FDA is a “man bites dog” event. More importantly, the outcome of this battle will affect every one of us manning the front line of dry eye syndrome (DES) treatment and probably every difficult-to-manufacture medication in all fields.
Did you ever wonder why it took so long to get a topical cyclosporine A medication to market? Not only is Restasis difficult to manufacture, the magic in the medicine is in the effectiveness of the whole product: active ingredient, vehicle and delivery system.
In my opinion, a simple demonstration that a generic medication has an equal amount of cyclosporine A will not be a demonstration that it will work in a similar fashion as Restasis. What makes me feel this way? One word: ketorolac. Does anyone feel that generic ketorolac works as well with as few side effects as Acular LS (ketorolac tromethamine ophthalmic solution 0.4%, Allergan) or Acuvail (ketorolac tromethamine ophthalmic solution 0.45%, Allergan)?
It is, however, bioequivalent.
Restasis has made the true medical treatment of DES possible. Indeed, absent Restasis we likely would not have many of the newer treatments available to us or would certainly not have seen the amount of research devoted to DES. Does anyone really want to switch their most challenging DES patients to a generic version of cyclosporine A that has not been tested clinically on real, live, honest-to-goodness unhappy DES patients? And for that matter, if and when it becomes clear that there is a measurable percentage of patients for whom the generic is not as helpful as Restasis, who is ready to spend more time than we already spend with these folks to convince them that they need the brand? Why accept this burden on faith?
Says here this is important. It’s important enough to get behind a big, rich company and help it show the FDA that clinical studies of this difficult-to-manufacture medication should be mandatory before a generic version of cyclosporine A is put on the market.
I know it’s kinda like cheering for the Yankees, but … .