PDUFA date set for December 27, 2017
LAVAL, Quebec, May 8, 2017 /CNW/ -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for brimonidine tartrate ophthalmic solution, 0.025% (Luminesse™*), and set a PDUFA action date of December 27, 2017. Luminesse is a topical vasoconstrictor formulation to be used Over-the-Counter (OTC) as an eye drop to relieve redness of the eye due to minor eye irritations. If approved, this will be the first OTC product developed with brimonidine tartrate for the treatment of ocular redness.
"The filing acceptance of Luminesse brings us one step closer to bringing a new treatment option to potentially help patients in the more than 14 million households who use OTC eye drops to treat ocular redness," said Joseph C. Papa, Chairman and CEO of Valeant. "If approved, Luminesse may provide patients with ocular redness significant benefits versus other competing redness reliever products currently available."
Six clinical studies were conducted to evaluate the safety and effectiveness of low-dose Luminesse in relieving ocular redness, including a study to demonstrate the absence of IOP-lowering potential of low-dose brimonidine. Bausch + Lomb also conducted a comprehensive review of all post-marketing safety data, as the active ingredient brimonidine tartrate is typically found to be used in prescription ophthalmic products. The drug was found to be highly efficacious and safe with low risk of tachyphylaxis (tolerance or loss of effectiveness) and rebound congestion, which are both common to currently available OTC redness reliever eye drops.
Luminesse was licensed by Eye Therapies, Inc., to Bausch + Lomb.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing and restoring people's eyesight. Its core businesses include over-the-counter supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in our industry, which is available in more than 100 countries.
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SOURCE Valeant Pharmaceuticals International, Inc.