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Restasis granted FDA approval
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IRVINE, Calif. – A dry eye drug that was previously denied U.S. regulatory approval has been given the go-ahead for use in the treatment of keratoconjunctivitis sicca by the Food and Drug Administration.
Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), is the “first and only therapy” for patients with keratoconjunctivitis sicca whose tear production is presumed to be suppressed due to ocular inflammation, according to an Allergan press release. Increased tear production was not demonstrated in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
In dry eye disease, Restasis is thought to act as a partial immunomodulator with anti-inflammatory effects; however, the exact mechanism of action is not known, according to Allergan.
Restasis was previously denied FDA approval in 1999, after an advisory panel expressed doubts about its efficacy.
In phase 3 studies that led to its current approval, Restasis demonstrated statistically significant increases in Schirmer test scores compared to vehicle at 6 months, according to the release from Allergan.
The most common adverse event for patients taking Restasis was ocular burning (17%). Other events occurring in fewer than 5% of the patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging and visual disturbance.
Allergan expects to launch the drug in early April next year. Full prescribing information can be obtained at http://www.restasis.com/.