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Don Murphy
Zeno Group, on behalf of Bausch + Lomb
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don.murphy@zenogroup.com
BAUSCH + LOMB RECEIVES FDA APPROVAL OF LUMIFY™ – THE ONLY OVER-THE-COUNTER (OTC) EYE DROP WITH LOW-DOSE BRIMONIDINE FOR THE TREATMENT OF OCULAR REDNESS
Clinical Studies Showed 95% Symptom Improvement At 60 Seconds, With Redness Reduction For Up To Eight Hours
BRIDGEWATER, N.J., Jan. 17, 2018 – Bausch + Lomb, a leading global eye health company, 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 has been clinically proven to be safe and effective since its initial approval as a prescription medication in 1996 for intraocular pressure (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,” said Joseph Gordon, president, Consumer Healthcare and Vision Care, Bausch + Lomb. “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.
“Ocular redness is a common, non-specific sign that brings many patients into our offices,” said Melissa Toyos, M.D., general ophthalmologist, dry eye specialist, cataract surgeon and facial cosmetic surgeon at Toyos Clinic. “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 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.”
LUMIFY will be available for purchase in major retailers in the second quarter of 2018.
For more information, please visit www.bausch.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.
The brimonidine tartrate ophthalmic solution 0.025% product was licensed by Eye Therapies, Inc. to Bausch & Lomb Incorporated or its affiliates.
LUMIFY is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2018 Bausch & Lomb Incorporated.
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