Bausch + Lomb Announces PDUFA Date For Luminesse
Source: Bausch + Lomb
Bausch + Lomb announced that the 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," Joseph C. Papa, Chairman and CEO of Valeant, said in a company news release. "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 to Bausch + Lomb.
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