New Jersey-based eye health company Bausch + Lomb has announced last week of the U.S. Food and Drug Administration (FDA) approval of LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%). It is the first over-the-counter 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.
“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.
“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.” said Joseph Gordon, president, Consumer Healthcare and Vision Care, Bausch + Lomb.
LUMIFY will be available for purchase in major retailers in the second quarter of 2018.
See the full press release from Bausch + Lomb.