Bausch + Lomb Receives FDA Approval of Lumify OTC Eye Drop for the Treatment of Ocular Redness
Source: Bausch + Lomb
Bausch + Lomb announced that the 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 has been clinically proven to be safe and effective since its initial approval as a prescription medication in 1996 for IOP reduction in glaucoma patients, and is available at higher doses in prescription ophthalmic products.
"We are proud to offer this unique new OTC eye drop to help our physicians and their patients with a new, effective treatment for red, irritated eyes,” Joseph Gordon, president, Consumer Healthcare and Vision Care, Bausch + Lomb, said in a company news release. “Lumify is an important addition to the diverse Bausch + Lomb portfolio of eye health products, and demonstrates our continued commitment to introducing new innovative products that meet the evolving needs of eye care professionals and the patients they treat.”
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, according to Bausch + Lomb.
“Ocular redness is a common, non-specific sign that brings many patients into our offices,” Melissa Toyos, MD, General Ophthalmologist, Dry Eye Specialist, Cataract Surgeon and Facial Cosmetic Surgeon at Toyos Clinic, said in the news release. “Lumify specifically reduces redness due to minor irritations while alleviating concerns of rebound hyperemia, dependency or tachyphylaxis—conditions that can lead to serious or permanent damage to the eye. I am excited to recommend Lumify to my patients to effectively relieve redness and help them get ‘camera ready’.”
To support approval of an OTC indication for Lumify, six clinical studies were conducted in over 600 patients to evaluate the safety and efficacy of low-dose brimonidine tartrate in relieving ocular redness, including studies with both pediatric and geriatric subjects. The double-blinded, randomized, placebo-controlled phase 3 efficacy study showed that 95% of subjects reported significant symptom improvement at 1 minute, while 79% of respondents maintained significant redness reduction at 8 hours. The strong efficacy and safety profile of brimonidine tartrate 0.025% includes not only significant redness reduction for up to 8 hours, but low-risk of allergic reactions among all patient groups.
“Patients with eye redness and irritation can experience negative social connotations, which may impact daily life,” said 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.”
Lumify will be available for purchase in major retailers in the second quarter of 2018.
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