8/16/22, 11 :22 AM
`
`FDA Approves LUMIFY™, a Brimonidine OTC for Ocular Redness I OphthalmologyWeb The Ultimate Online Resource for Opht. .
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`The most likely diagnosis is:
`
`ill a. congenital glaucoma
`[ check the answer I
`
`b. bir h trauma
`c. hypotony
`d. enlarged corneal nerves
`
`News FDA Approves LUMIFY™, a Brimonidine OTC for Ocular Redness
`
`FDA Approves LUMIFY™, a Brimonidine OTC for
`Ocular Redness
`
`Posted: January 22, 2018
`Tweet
`Share Email
`
`Comments
`
`New Jersey-based eye heal h company Bausch
`+ Lomb has announced last week of the U.S.
`
`Food and Drug Administration (FDA) approval of
`
`LUMIFY"' (brimonidine tartrate ophthalmic
`
`solu ion 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) reduc ion in glaucoma patients,
`
`and is available at higher doses in prescription
`
`oph halmic products.
`
`BAUSCH LOMB
`
`•ocular redness is a common, non-specific sign hat brings many patients into our offices." said Melissa Toyos, M.D.,
`general oph halmologist, 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-<lose 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 reduc ion 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 reac ions among all
`
`patient groups.
`
`"LUMIFY is an important addition to the diverse Bausch+ Lomb portfolio of eye health products, and demonstrates
`
`our con inued commitment to introducing new innovative products that meet he 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 twLoress release fmm Bausch + I omb
`
`Source : Bausch+ Lomb
`
`Comments
`
`Selected Products
`
`Featured Products
`
`SPECTRALIS
`Diagnostic
`Imaging Platform
`A modular and
`upgradeable
`ophthalmic ...
`.lal:ltLllWWl'1.
`
`Selecta Trio™
`YAG laser, SLT
`and
`Photocoagulation
`The Lumenis Selecta®
`Trio"'.
`~P.!odUCt
`
`view all featured oroducts •
`
`Follow OphthalmologyWeb
`
`Keep up with our latest articles, news and events.
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`https://www.ophthalmologyweb.com/1315-News/346489-FDA-Approves-LUMIFY-a-Brimonidine-OTC-for-Ocular-Redness/
`
`1/2
`
`Eye Therapies Exhibit 2115, 1 of 2
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`FDA Approves LUMIFY™, a Brimonidine OTC for Ocular Redness I OphthalmologyWeb The Ultimate Online Resource for Opht. .
`
`Welcome Guest
`
`Sign In
`
`Register
`
`Search Ophthalmo/ogyWeb
`
`Home
`
`I Cataract
`
`Cornea
`
`Glaucoma Refractive
`
`Retina
`
`Practice Management
`
`News
`
`Events
`
`Articles
`
`Product Center
`
`Featured Products
`
`Videos
`
`Quick Quiz
`
`The most likely diagnosis is:
`
`ill a. congenital glaucoma
`[ check the answer I
`
`b. bir h trauma
`c. hypotony
`d. enlarged corneal nerves
`
`News FDA Approves LUMIFY™, a Brimonidine OTC for Ocular Redness
`
`FDA Approves LUMIFY™, a Brimonidine OTC for
`Ocular Redness
`
`Posted: January 22, 2018
`Tweet
`Share Email
`
`Comments
`
`New Jersey-based eye heal h company Bausch
`+ Lomb has announced last week of the U.S.
`
`Food and Drug Administration (FDA) approval of
`
`LUMIFY"' (brimonidine tartrate ophthalmic
`
`solu ion 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) reduc ion in glaucoma patients,
`
`and is available at higher doses in prescription
`
`oph halmic products.
`
`BAUSCH LOMB
`
`•ocular redness is a common, non-specific sign hat brings many patients into our offices." said Melissa Toyos, M.D.,
`general oph halmologist, 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-<lose 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 reduc ion 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 reac ions among all
`
`patient groups.
`
`"LUMIFY is an important addition to the diverse Bausch+ Lomb portfolio of eye health products, and demonstrates
`
`our con inued commitment to introducing new innovative products that meet he 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 twLoress release fmm Bausch + I omb
`
`Source : Bausch+ Lomb
`
`Comments
`
`Selected Products
`
`Featured Products
`
`SPECTRALIS
`Diagnostic
`Imaging Platform
`A modular and
`upgradeable
`ophthalmic ...
`.lal:ltLllWWl'1.
`
`Selecta Trio™
`YAG laser, SLT
`and
`Photocoagulation
`The Lumenis Selecta®
`Trio"'.
`~P.!odUCt
`
`view all featured oroducts •
`
`Follow OphthalmologyWeb
`
`Keep up with our latest articles, news and events.
`Plus, get special offers and more delivered to your
`inbox.
`
`Your Email Address
`
`Like us
`on Facebook
`
`Follow us
`on Twitter
`
`https://www.ophthalmologyweb.com/1315-News/346489-FDA-Approves-LUMIFY-a-Brimonidine-OTC-for-Ocular-Redness/
`
`1/2
`
`Eye Therapies Exhibit 2115, 1 of 2
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`8/16/22, 11 :22 AM
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`FDA Approves LUMIFY™, a Brimonidine OTC for Ocular Redness I OphthalmologyWeb The Ultimate Online Resource for Opht. .
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`https://www.ophthalmologyweb.com/1315-News/346489-FDA-Approves-LUMIFY-a-Brimonidine-OTC-for-Ocular-Redness/
`
`2/2
`
`Eye Therapies Exhibit 2115, 2 of 2
`Slayback v. Eye Therapies - IPR2022-00142
`
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