Clinical Studies Showed 95% Symptom Improvement At One Minute, And Reduced Redness For Up To Eight Hours LAVAL, Quebec, Dec. 22, 2017 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant"), today announced that the U.S. Food and Drug Administration (FDA) has approved LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%) as the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. Brimonidine, which was first approved by the FDA in 1996 for intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in prescription eye care products.
"With today's approval of LUMIFY, consumers have a new and unique treatment option to relieve red, irritated eyes," said Joseph C. Papa, chairman and CEO of Valeant. "LUMIFY is the first and only OTC eye drop with low-dose brimonidine, which has been clinically proven to be safe and effective since its initial approval as a prescription medication in 1996. We expect LUMIFY will be available for purchase in major retailers in the second quarter of 2018."
Ocular redness is a common condition that can be caused by inflammation of almost any part of the eye. With frequent use, non-selective redness relieving eye drops that constrict blood vessels in the eye can result in users developing a tolerance or loss of effectiveness, as well as rebound redness. In contrast, low-dose brimonidine, the active ingredient in LUMIFY, selectively constricts veins in the eye, increasing the availability of oxygen to surrounding tissue, thereby reducing the potential risk of these side effects.
"Patients with eye redness and irritation can experience negative social connotations, which may impact daily life," said Dr. Paul Karpecki, OD, FAAO, Director of Corneal Services at Kentucky Eye Institute. "Having a drop that reduces redness without the side effects of rebound hyperemia or tachyphylaxis, which may lead to overuse and potential corneal toxicity, is a very exciting option that I look forward to recommending to my patients."