It’s the first low-dose brimonidine tartrate drug for the condition.
LAVAL, QUEBEC — Bausch + Lomb announced that the U.S. Food and Drug Administration has approved Lumify for the treatment of ocular redness.
The company described the drug as "the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate" for the condition.
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 eyecare 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.
Papa said it's expected that Lumify (brimonidine tartrate ophthalmic solution 0.025%) will be available for purchase in major retailers in the second quarter of 2018.
In a press release, Bausch + Lomb noted that 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 selectively constricts veins in the eye, increasing the availability of oxygen to surrounding tissue and reducing the potential risk of these side effects, the company said.
"Patients with eye redness and irritation can experience negative social connotations, which may impact daily life," said Dr. Paul Karpecki, director of corneal services at Kentucky Eye Institute, said in the release. "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."
The product was licensed by Eye Therapies Inc. to Bausch + Lomb, which is a subsidiary of Valeant Pharmaceuticals International, Inc.