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New Acular formulation gains FDA approval

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Ketorolac tromethamine ophthalmic solution 0.4% received marketing approval from the Food and Drug Administration earlier this week, according to Allergan, the drug’s manufacturer.

Acular LS, a lower concentration of a drug already on the market, was granted U.S. regulatory approval for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

According to an Allergan news release, Acular LS is an optimized fomulation of ketorolac tromethamine. The company expects to launch the product some time in the third quarter.

Acular 0.5%, Allergan’s current version of the product, is approved for the treatment of inflammation following cataract surgery. Both products inhibit prostaglandin formation through both COX-1 and COX-2.

Allergan noted that Acular is the No. 1 prescribed ophthalmic nonsteroidal anti-inflammatory drug with 3.6 million prescriptions written each year.