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February 2018

A Clear-eyed View of Restasis and Chronic Dry Eye Disease

Author Affiliations
  • 1The Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire
JAMA Intern Med. 2018;178(2):181-182. doi:10.1001/jamainternmed.2017.7904

In a legal maneuver that has left many rubbing their eyes, Allergan recently transferred the 6 patents on its blockbuster “dry eyes” drug Restasis (cyclosporine ophthalmic emulsion, 0.05%) to the Saint Regis Mohawk Tribe, which will exclusively license the patents back to the company. The deal, which may delay the marketing of generic alternatives to Restasis, is under legal challenge, amid calls for Congress to ban the strategy Allergan has sought to exploit.

But the more fundamental question has received little attention: does Restasis work? Restasis is not approved in the European Union, Australia, or New Zealand, where in 2001 registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy.”1 Although Canada approved Restasis,2 its national health technology assessment unit, unconvinced of meaningful benefit, recommended Canada not pay for it.3 Our research found no Canadian provincial or federal drug plan that currently does.

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