Wednesday, June 13, 2007

Off-label use of drugs in dry eye

I was working last night on the prescription drug section of our soon-to-be-launched Dry Eye Yellow Pages.

At first blush, you'd think gee, that will be an awfully short list: Restasis, which is the only drug approved by the FDA for dry eye. (Actually that's probably not quite true - there is also FreshKote which is sold on a prescription basis exclusively for dry eye. Incidentally it's a very good drop and if you haven't tried it you should.)

Anyway, as it turns out I was quite surprised at how long a list I managed to come up with in just ten minutes. There are a TON of drugs used for dry eye: corticosteroid drops, nonsteroidal antiinflammatories, ointments of various sorts, specially compounded drugs like androgen or testosterone creams or drops and doxycycline drops, and oral antibiotics, and more.

Some of these are prescribed in an attempt to actually treat the cause such as meibomian gland dysfunction; others to fight inflammation; some to make Restasis more endurable (oops, I mean improve Restasis compliance), some to fight conditions secondary to dry eye.

While I was in the middle of jotting down my list, a friendly little Google dry eye alert dropped into my email with the following article and I thought, Gosh, how apropos...

Patients need to ask questions about off-label drug use


Columbia University physician Dr. R. Linsy Farris, for example, prescribes a drug that has been approved for respiratory problems for people with dry eye

"We found out that in dry-eye patients, who frequently have trouble rinsing away the mucous that develops in the eye, that if we use this as an eye drop, it would liquefy the mucous there," Farris said. "They would not have trouble as much with the discomfort."

But Consumer Reports said patients should ask their doctors if a medication prescribed for them is FDA-approved for that condition. If it hasn't even been tested for the condition, ask the doctor why that medication is being prescribed, the magazine said.

"If you're going to be taking a drug for a particular condition, you want to know that it's been shown to actually work for that condition," Sandroff said. "You also want to know that the risks and side-effects of taking that drug are minimal, and they have been studied."

Newsclip: FreshKote EU approved

Sorry for the very late update on this (happened last November) - not sure how I managed to miss it.

From "Review of Ophthalmology Online":

EU APPROVES FRESHKOTE DRY EYE FORMULA. Aqueous Pharma, Ltd., has received European Union approval of its FreshKote three-layered artificial tear formula for dry eye disease. This approval was granted via a CE Mark by a EU registered notified body. FreshKote is approved for sale in all 25 countries of the EU. The formula, which was recently launched in the United States by FOCUS Labs of Arkansas, is patent pending