The FDA only approved Restasis because of improved eye wetness tests - not more symptom relief or less artificial tear use
The FDA initially rejected Restasis because it (and an FDA Advisory Committee) felt that the clinical trials did not prove that the drug helped people with dry eyes feel better. The FDA approved the drug - based on the same clinical trials - because a new analysis showed that more people on Restasis (compared to Placebo) had enough wetness on a paper strip put in their eye: 15% vs 5% of people. Artificial tear use was almost the same: 4.1 times a day with Restasis vs 4.6 times a day with Placebo. Since Restasis is used twice a day, people will be using more total drops a day. The trials did not prove to the FDA that people felt their dry eye symptoms were better.
Restasis's most common side effect was burning eyes: 17% of people taking Restasis
To increase tears for dry eye syndrome. Restasis did not increase tears in people with dry eyes who were using punctal plugs (a treatment for dry eyes) or other anti-inflammatory drugs.
Who might consider taking it?
Adults and teenagers older than 16 years bothered by dry eye disease (diagnosed by an ophthalmologist because of symptoms and inflammation on the surface of the eye) despite trying other treatments such as artificial tear drops, gels and ointments
What is not known
If Restasis made people feel that their dry eye symptoms improved
Not tested in children younger than 16 years
LONG TRACK RECORD
Long track record means that new‚ unexpected side effects are unlikely. Cyclosporine was first approved by FDA in 1983 for in capsule form for preventing the rejection of organ transplants (kidney, liver, and heart) and approved in eye drop form for dry eye in 2002. Since Cyclosporine has now been used by large numbers of people over a longer time in eye drop form for dry eye‚ the emergence of rare but serious side effects is less likely than with new drugs.
NO ONGOING STUDIES
Do not take if you...
Are allergic to Restasis or its ingredients
Not recommended if you...
No other reasons listed by FDA
Safe if pregnant or breastfeeding?
Only take if potential benefits outweigh potential harm to baby (FDA Category C)
Be cautious about breastfeeding - Restasis gets into breast milk
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