Last month I wondered whether or not we need another branded cyclosporine A medication on the market to treat dry eye disease. Given the fact that the whole CsA game is about the mechanism of delivery, my answer to that question is a reluctant “I guess so.” Largely because having a third on-label CsA-approved DED drug is not likely to make one iota of difference in the real battle we fight in the clinic: getting insurance to pay for our patients’ DED medicine. Having another drug — we’re now up to three — is nice and all, but both practices and patients have to work too hard to get access to meds to treat the chronic part of their disease.
What about steroids then? At the moment we have precisely one medication with an on-label indication to treat DED. Flarex (fluorometholone acetate ophthalmic suspension, Eyevance) is approved to treat “inflammatory diseases of the ocular surface,” of which DED is certainly the most common. Bausch + Lomb dropkicked the original Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) out of play when it repeatedly declined to market the on-label treatment of superficial punctate keratitis. Every form of loteprednol approved since has not had this on-label indication. Kala is now reporting that it has fully enrolled its phase 3 trial of Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%) for the treatment of acute DED symptoms; results are expected in April. Do we need another loteprednol to treat DED?
DED is an inflammatory disease. As such, steroids are highly effective in treating almost all of its symptoms, acute or chronic. Why, then, aren’t steroids prescribed more often? It comes down to safety, both real and presumed. Steroids are scary, right? Poppycock. All steroids are not the same. Heck, even all forms of the same steroid aren’t the same (for instance, fluorometholone acetate is superior to fluorometholone alcohol). Both loteprednoand fluorometholone have very low complication rates, especially if prescribed by eye doctors who then follow up with the patient to check IOP.
Having a label that includes DED is very helpful when one must do battle with insurance companies and pharmacy benefit managers. Mitch Jackson is famous for his response when his medicine of choice is replaced by an inferior option not approved for the disease in question: “Let me make sure I am understanding you correctly; you want me to prescribe an unapproved medication to treat my patient when I have written for one that is FDA approved for this very problem. Please tell me the correct spelling of your name so that I can share that with my patient and her lawyers.”
Yes, we need another steroid that is FDA approved for the treatment of DED. While we’re at it, let’s make that another two or three. There won’t be enough Flarex and Eysuvis available if we all use steroids as frequently as we should.
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.