`the Management
`of Red Eye
`How Clinical Advancements
`Are Evolving Eye Care Practice
`
`CONTRIBUTORS:
`
`Mile Brujic, OD, FAAO
`Premier Vision Group, Bowling Green, OH
`
`Arthur B. Epstein, OD, FAAO
`Phoenix Eye Care, Phoenix, AZ
`
`Whitney Hauser, OD, FAAO
`The Eye Specialty Group, Memphis, TN
`
`Paul M. Karpecki, OD, FAAO (Moderator)
`Kentucky Eye Institute, Lexington, KY
`
`Eye Therapies Exhibit 2199, 1 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Enhancing
`the Management
`of Red Eye•
`
`Dear Colleagues,
`
`For many years, we in eye care had few reliable options to offer patients in the area of ocular redness relief due to
`minor eye irritation-commonly from conjunctiva! inflammation leading to vasodilation of the conjunctiva! blood
`
`vessels.1•2 We knew that redness could be triggered by issues such as allergy, infection, dryness or fatigue,2 in addi(cid:173)
`tion to prolonged visual tasking and contact lens wear,2 and more recently digital eye strain3 and cosmetic lash treat(cid:173)
`ments.4·5 But we often avoided bringing up redness during our conversations with patients unless it was severe since
`we weren't able to effectively manage the symptoms.
`
`Over time, a percentage of our patients who were frustrated by their readily apparent red eyes went in search of over(cid:173)
`the-counter medications such as topical vasoconstrictors marketed as eye redness relievers. However, these products
`potentially introduced unwanted side effects such as tachyphylaxis,6 rebound vasodilation,7 toxicity,8 and risk of over(cid:173)
`use.8 As a result of these possible complications, many of us advised against using these products; yet, a number
`of our patients persisted in employing them, frequently leading to rebound redness, protracted application, and a
`repeated cycle of ocular redness.
`
`Starting in 2017 with the introduction of an eye redness relieving eye drop, eye care providers were presented with a
`tremendous opportunity to advance clinical practice in an area of eye care critically in need of our attention. With the
`addition of LUMIFY® Redness Reliever eye drops to our management protocols, many of us began experiencing first(cid:173)
`hand the giant leap forward this product has taken eye redness relief.
`
`For one thing, science has borne out the product's safety and efficacy. Research has shown that the mechanism of
`action of LUMIFY® can safely and efficaciously address ocular redness. In clinical trials, there were no reported serious
`side effects such as intraocular pressure changes, allergic reaction, or pupil effects; no reports of tachyphylaxis, and
`few reports of rebound vasodilation.2 Remarkably, it can do so within a minute of installation for up to eight hours.2
`In addition, the positive clinical effect LUMIFY® has had on so many of our patients has been nothing short of remark(cid:173)
`able. We have observed during office demonstrations patients' eyes literally change from red with minor irritation, to
`clear and quiet in 60 seconds. Looking through a wider lens, we have seen the myriad ways a new offering in redness
`relief can elevate our patients' eye care experience, in addition to their confidence in us as practitioners.
`
`LUMIFY® (brimonidine tartrate ophthalmic solution 0.025%) is the first and only over-the-counter eye drop developed
`with low-dose brimonidine tartrate for the treatment of ocular redness due to minor eye irritations. Its importance for
`eye care practice today should not be overlooked. In the following discussion, we explain reasons why optometric
`professionals who want to stay at the forefront of eye care developments need to take a closer look at implementing
`this essential product in their practices.
`
`-- Paul M. Karpecki, OD, FAAO
`
`CONTRIBUTORS:
`
`Mile Brujic, OD, FAAO
`Premier Vision Group, Bowling G reen, O H
`
`Arthur B. Epstein, OD, FAAO
`Phoen ix Eye Care, Phoen ix, AZ.
`
`Whitney Hauser, OD, FAAO
`The Eye Specialty Group, Memphis, TN
`
`Paul M. Karpecki, OD, FAAO (Moderator)
`Kentucky Eye Institut e, Lexington, KY
`
`Contributors are paid consultants of Bausch + Lomb
`
`2 Review of Optometry I June 2020
`
`Eye Therapies Exhibit 2199, 2 of 12
`Slayback v. Eye Therapies - IPR2022-00142
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`
`
`Presentation & Treatment of Red Eye
`
`Dr. Karpecki: What are the more common caus(cid:173)
`es of red eye that you see in your practice?
`
`Dr. Karpecki: We're all very busy, and if the pa(cid:173)
`tient is not complaining about redness, a lot of
`times it gets overlooked. How do you approach
`your diagnosis when it comes to redness?
`
`Dr. Epstein : We are seeing patients who
`work longer hours and who are using their
`computers much more extensively. Patients
`are also presenting with a greater prevalence
`of dry eye symptoms, and they are using an
`increasing number of medications than in the
`past. In general, this is a time where we're see-
`ing more and more redness, and more and more
`patient awareness of it as well.
`
`Dr. Hauser: Working in a tertiary dry eye center, I
`see a lot of redness that is related to dry eye and
`other ocular surface disease-blepharitis, allergy,
`and so forth.
`
`Dr. Brujic: Oftentimes, these patients are
`hyper-cognizant of the condition and how it
`makes their eye look.
`
`When to Schedule Your Patient for More
`Serious Causes of Red Eye
`By Paul M. Karpecki, OD, FAAO
`
`It's important to recognize eye redness secondary to
`minor irritation. But many patients don't have the
`ability to distinguish a red eye caused by minor
`irritation that will do well with LUMIFY® Redness
`Reliever eye drops from one caused by more serious
`underlying conditions-such as infection, corneal ulcer,
`neurotrophic keratitis, acute angle closure--that needs
`to be addressed immediately and evaluated in an
`exam. Here is a partial list of symptoms that may help
`the practice determine if a red eye requires immediate
`attention and scheduling:
`• Decreased or blurred vision
`• Pain
`• Photophobia
`• Severe headache
`• Halos around lights
`• Nausea
`• Discharge
`
`Dr. Epstein: One of the things I like to do is, as I'm
`summing up a case and how I'm going to approach
`
`Protocols for Causes of Redness Secondary
`to Minor Irritation
`By Paul M. Karpecki, OD, FAAO
`
`1. Redness secondary to meibomian gland
`dysfunction (MGD)/mild blepharitis. Four compo(cid:173)
`nents typically must be addressed in patients with mild
`MGD/blepharitis: obstructed meibomian glands (MGs),
`biofilm, tear film, and redness. A clinician can control
`mild blepharitis with hydrating or moist compresses,
`blink exercises, lid hygiene and possibly omega-fatty
`acid supplements. LUMIFY® Redness Reliever eye
`drops can be used for residual eye redness.
`
`2. Redness secondary to mild allergic conjunctivitis.
`Mild allergies are another common condition in North
`America and a common cause of eye irritation, itching,
`and redness. This condition requires treating the
`allergic conjunctivitis and redness, and supporting the
`tear film, as many topical and oral antihistamines cause
`eye dryness. Options for mild allergic conjunctivitis
`include cool compresses, topical antihistamine drops
`either over-the-counter or by prescription. Many of
`these therapeutic anti-histamine drops also stabilize
`mast cells. The tear film can be supported with preser(cid:173)
`vative-free artificial tears. Residual eye redness can be
`managed with LUMIFY® Redness Reliever eye drops.
`
`3. Mild or episodic dry eye. Mild or episodic, as
`opposed to chronic, dry eye causes temporary symp(cid:173)
`toms of dryness, burning, and irritation. Patients often
`experience symptoms later in the day, while in dry
`environments or after extensive digital device use. This
`condition requires treating the obstructed MGs, mild
`dry eye, the tear film, and redness. Treatments may
`include hydrating compresses, in-office lid debride(cid:173)
`ment, microblepharoexfoliation, and thermal pulsation/
`expression procedures. The dry eye component can
`be treated with oral omega fatty acids, and topical dry
`eye therapies such as cyclosporine or lifitegrast. The
`tear film can be supported with artificial tears and envi(cid:173)
`ronmental changes. Residual redness can be addressed
`with LUMIFY® Redness Reliever eye drops.
`
`Sponsored by BAUSCH cJ, LOMB
`
`Eye Therapies Exhibit 2199, 3 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Enhancing
`the Management
`of Red Eye•
`
`it, I'll ask patients if redness bothers them. If they
`say yes, I tell them to go look in the mirror. After(cid:173)
`ward, they usually say something like, 'My eyes are
`kind of red.' I hand them a tissue and put a drop of
`LUMIFY® Redness Reliever eye drops in each eye,
`and I continue with the conversation. After about
`a minute, I say, "Do me a favor, and go take a look
`at your eyes again." Most patients are amazed at
`how their eyes look because the redness has been
`reduced. At the same time, they look at me
`differently than they did before because now they
`have proof positive that I know what I'm doing.
`
`Dr. Hauser: Now that I have another option to
`treat the patient's redness, it makes me open
`that discussion up more proactively. I think a lot
`
`of doctors have a "don't ask, don't tell" policy
`when it comes to things like redness. They might
`identify it as part of their exam and put hyperemia
`in the chart, but they don't usually address it with
`patients. Now, I feel like I broach the subject a lot
`more with patients. And once you ask the ques(cid:173)
`tion, once you talk to them about it, you realize
`what a high priority it is for them.
`
`Dr. Brujic : I agree. I think redness was one of
`those conditions that we tried to ignore because
`we needed more options for it. So now that we
`have another option, and now that we can imme(cid:173)
`diately show the patient the ramifications of that
`option, it's just created a whole new conversation
`with this patient.
`
`4 Review of Optometry I June 2020
`
`Eye Therapies Exhibit 2199, 4 of 12
`Slayback v. Eye Therapies - IPR2022-00142
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`
`
`Step Back from the Slit Lamp to Better Identify
`Redness
`
`Dr. Hauser: One of the things I would recommend
`to colleagues is to look at your patient outside of
`the slit lamp. I think that we might identify redness
`better just in conversation, just like the patient's
`colleagues do, like their coworkers do. Because
`once you get behind the slit lamp, everything 's
`magnified, and you're busy looking for superficial
`punctate keratopathy and corneal staining. And
`sometimes we just, I think, casually swing past the
`hyperemia there.
`
`Dr. Epstein: It's funny because I always tell my-
`self, 'Shut up, and listen to the patient.' But it's
`not just listening to the patient . It's looking at the
`patient. And I think that's almost an art form that
`has been lost over the years in terms of training
`new students. You get much more information from
`a patient just by that brief conversation, by looking
`at them, how they sit, how they walk, and looking at
`their eyes before you put them behind the slit lamp.
`
`Dr. Karpecki: How does LUMIFY® Redness
`Reliever eye drops fit within the treatment reg(cid:173)
`imen for dry eye-related conditions?
`
`Dr. Hauser: With the chronic progressive nature
`of dry eye, we treat the dry eye disease with an
`appropriate product; however, one of the more
`lingering effects that the patient can have is hy(cid:173)
`peremia. We may see improvements in the cor(cid:173)
`nea, we may see improvements in vision, but the
`patient may still have that little bit of lingering
`redness. And effective red eye relief has been
`the final thing that I have struggled to satisfy the
`patient with. So having something now that I can
`add on for that patient, that really is the icing on
`the cake.
`
`Broaching the Subject of Redness
`Relievers With Patients
`
`Dr. Karpecki: When asked about their current
`medications, many patients won't list topical
`over-the-counter products for ocular redness
`
`Self-Treatment to Address a Pervasive Issue
`for Patients
`
`Dr. Karpecki: A high percentage--9 out of 10 patients(cid:173)
`report self-medicating at some point for ocular redness
`due to minor irritation.9 So we know that ocular redness is
`impacting our patients from an emotional standpoint if they
`are so motivated to self-treat.
`
`Dr. Brujic: I think self-treating eye redness is a red flag
`to the profession. I think that speaks volumes about the
`degree that this affects patients.
`
`Dr. Hauser: More than anything else, what I hear is that pa(cid:173)
`tients report that friends, family members, and coworkers
`identify it, and it's a point of embarrassment for them.
`
`Dr. Karpecki: And their identification with [redness], unfor(cid:173)
`tunately, in their minds, in their coworkers', their families'
`[minds] is: Have they been crying, which is negative; have
`they been not sleeping, which is negative; have they been
`drinking, binging; going out too long, late at night?
`
`Dr. Epstein: One female patient with eye redness told me
`she thought she looked like a vampire. So I darified, "You're
`here specifically because your eyes are red, and is that a big
`issue?" She said, "Yeah, it literally dominates my whole life."
`
`Dr. Brujic: That single statistic of patients' self-
`medicating highlights how important it is in
`patients' minds. So if we're not offering them options,
`what's happening is many of them are going and trying to
`figure out what the best solution is.
`
`Dr. Epstein: Patients are finding ways of dealing with a
`problem that you're ignoring, and you're an eye doctor, and
`it's an eye problem.
`
`Dr. Hauser: Many patients think red eye is frivolous to us,
`so they're not necessarily going to be the ones to bring that
`to our attention. As a profession, we have to be proactive.
`
`because, one, they are over-the-counter, and
`two, patients think 'it's just a redness reliever.'
`At the same time, many of our colleagues will
`not address redness if the patient isn't com(cid:173)
`plaining, as a number of us tended to do be(cid:173)
`fore LUMIFY® Redness Reliever eye drops were
`available. How do you bring up eye redness?
`
`Dr. Brujic: I was guilty of this a few years ago-I
`
`Sponsored by BAUSCH cJ, LOMB
`
`Eye Therapies Exhibit 2199, 5 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Enhancing
`the Management
`of Red Eye•
`
`Purpose
`Active ingredient
`Brimonidine tartrate (0.025%) ............................ Redness reliever
`Use
`■ relieves redness of the eye due to minor fY"Je irritations
`
`Do not use
`■ if solution cllanges color or becomes cloudy
`Stop use and ask a doctor if
`■ you experience eye pain, changes in vision, continued
`redness or irritation of the eye
`■ condition worsens or persists for more than 3 days
`H pregnant or breast-feeding, ask a health professional
`before use.
`Keep out of reach of children. If swalowed, get medical help
`or contact a Poison Control Center right away.
`Directions
`■ adults and children 5 years of age and over:
`■ instill 1 drop in the affected eye(s) every 6-8 hours
`■ do not use more than 4 limes daily
`■ re move contact lenses before use
`■ wait at least 10 minutes before re-inserting contact lenses
`after use
`■ if using o1her ophthalmic products while using this
`product, wait at least 5 minutes between each product
`■ to avoid contamination, do not touch tip of container to
`any surface
`■ replace cap after each use
`■ children under 5 years of age: consult a doctor
`
`Other information
`■ store at 15°-25°C
`(59°-77°F)
`Inactive ingredients
`benzalkonium chloride, boric
`acid, calcium chloride
`dihydrate, glycerin, potassium
`chloride, sodium borate
`decahydrate, sodium chloride,
`water for injection.
`Hydrochloric acid and/or
`sodium hydroxide may be used
`to adjust pH.
`Questions or
`comments?
`( Call: 1-800-553--5340
`
`would examine my most severe patients and think,
`'Well, this is something that I have to bring up.'
`And I would start molding the conversation.
`Now, if I've identified the patient as having any
`hyperemia that I feel is more than the normal,
`quiet, white eye, I ask them: 'Do you ever wish
`your eyes were less red?'
`
`Dr. Karpecki: I always ask the question: 'Do your
`eyes ever get red?' Not meaning they are today, I
`just want to know where the patient is at.
`
`Addressing Previous Redness Relievers
`
`Dr. Karpecki: With the development of LUMIFY®
`Redness Reliever eye drops, management of
`ocular redness has improved dramatically for
`many of us in practice. What were some of the
`issues associated with previous eye redness
`relievers?
`
`Dr. Epstein: We became zealots at telling our
`patients to stay away from over-the-counter
`products because of their potential for rebound
`redness.
`
`Dr. Hauser: The ideal redness reliever is something
`that you can use only when needed. When you have
`associated rebound redness with a product, it's a
`cycle of "and now I need some more" to avoid the
`rebound. So it's a cycle that patients have difficulty
`getting off of vs. treating a minor redness problem
`with a product that they would use periodically.
`
`Dr. Brujic: These products were the ones that carried
`side effects that may not necessarily be as desirable and
`may have more potential to cause long-term damage
`than they can actually benefit to the eyes.
`
`How Changing Patient Characteristics
`Affect Management
`
`Dr. Karpecki: When it comes to increasing issues
`
`6 Review of Optometry I June 2020
`
`Eye Therapies Exhibit 2199, 6 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`related to dry eye, digital eye strain, the popularity
`of cosmetic products and eyelash extenders, etc.,
`how is that impacting the management of ocular red(cid:173)
`ness in your patient base?
`
`Dr. Hauser: You really hit on a demographic-that has
`dry eye disease, that uses cosmetic products and digital
`devices, all in one patient now. We always talk about the
`multifactorial nature of dry eye disease, but the modern
`lifestyle is multifactorial, too. And we can treat the dry(cid:173)
`ness, talk to patients about how to remove products, but
`there's always going to be that little underlying element
`that tends to linger, which is oftentimes the redness
`component. So I don't think we're going to be able to
`change our patients' lifestyles 100 percent. We can make
`some adjustments, but they're not going to discontinue
`using a lot of these products, they're not going to get off
`their phones. And I think that we have to help them work
`around that when they have occasional redness.
`
`Dr. Brujic: Now we have something in our armamentarium
`that we can recommend safely to these patients. You don't
`have to wonder what the patient is going to do when they
`leave your office, if there still is this smoldering or lingering
`redness that you're working on, and you wonder if they're
`going to be doing something that you don't want them
`doing at home. Now we can give them direct
`recommendations on what to use.
`
`A Leap Forward: The Mechanism of Action of
`LUMIFY®
`
`Dr. Karpedci: Brimonidine tartrate, the active
`ingredient in LUMIFY® Redness Reliever eye drops,
`has been around for more than 20 years and is a
`second-generation glaucoma medication and adrenergic
`receptor agonist. At higher doses, it was used for
`lowering intraocular pressure and was associated with
`hyperemia; at low doses, it was used to reduce red(cid:173)
`ness. 2 In the dinical trial to validate safety and efficacy
`of LUMIFY® (brimonidine t.artrate ophthalmic solution
`0.025%), there were no reports of abnormal IOP
`elevation, pupil effects, or allergic reaction.2
`
`The MOA of LUMIFY® Explained
`
`LUMIFY® Redness Reliever eye drops' active
`ingredient is low-dose brimonidine tartrate (0.025%),
`a selective imidazoline a2-adrenergic receptor agonist
`that has a relative a2-adrenergic receptor binding
`affinity 1,000 times greater than for a1-adrenergic re(cid:173)
`ceptors.9 Some topical vasoconstrictors are consid(cid:173)
`ered selective a1-adrenergic receptor agonists, while
`others are considered mixed a1 /a2-adrenergic receptor
`agonists.2 Brimonidine tartrate affects vasoconstric-
`tion primarily via the a2-adrenergic receptor, which is
`associated with less tachyphylaxis and rebound redness
`when used as directed.2 Studies in nonocular tissues
`suggest that a2-adrenergic receptor agonists selec(cid:173)
`tively constrict veins, helping to avoid the potential
`decrease of blood flow and oxygen to surrounding
`tissues, and helping to prevent occurrence of gener(cid:173)
`alized ischemia, which begins the cascade leading to
`rebound redness.10,11 Unlike a1-adrenergic receptor
`agonists, brimonidine tartrate does not impact receptor
`down-regulation to the same extent.6
`
`Dr. Epstein: We need to educate patients. Patients
`sometimes wonder, if this is a drug are there risks
`associated with it? Well, there's risks associated with
`everything, but this is a drug that's been used in a much
`higher concentration for more than 20 years, and it's
`been my experience that there have been virtually no
`issues whatsoever, although I am aware that allergic
`conjunctivitis, conjunctiva! hyperemia, and eye pruritus
`are possible adverse events.
`
`Dr. Hauser: Many of us treat a lot of dry eye patients
`who have a chronic disease. And we have a long-term
`treatment plan for these individuals. The difference with
`using LUMIFY® Redness Reliever eye drops for occasional
`redness is the happiness factor that I usually do not get
`to bestow on my patients.
`
`Dr. Karpedci: Is there anything you find exciting
`about the mechanism of action of LUMIFY®?
`
`Dr. Epstein: Its longevity. The fact that it will last for up to
`eight hours is actually quite surprising.
`
`Dr. Brujic: How quickly it functions is remarkable. It
`
`Sponsored by BAUSCH cJ, LOMB
`
`Eye Therapies Exhibit 2199, 7 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Enhancing
`the Management
`of Red Eye•
`
`with a primary complaint of redness and some underlying
`dry eye, which we treated as well. She had been unable to
`get a job after many job interviews, despite the fact that
`she felt very qualified for the advertised positions. She
`said, "You know, I've been through 22 job interviews, and
`I really feel like they're looking at my red eyes the whole
`time and assuming things that are not the case." I told her
`about a new product available for redness and that she
`would be one of my first patients to try it. About a week
`after she tried LUMIFY® Redness Reliever eye drops, she
`called the office to tell us that she had gotten a job on her
`next interview. I don't think it was because the redness had
`been relieved so her eyes appeared whiter, I think it was
`just that her confidence was improved.
`
`Dr. Epstein: For some professions, appearance is a critical
`issue-sales, for example. I've had salespeople come in
`saying, "I just look like I'm wrecked, like I'm always not
`sleeping." Now I can demo LUMIFY® Redness Reliever
`eye drops and give them a product that could make
`a meaningful difference to them.
`
`Dr. Hauser: And we live in a society where certain age
`groups-and the age groups are expanding-are active
`on social media. When you're on social media, there are
`a lot of tricks and filters and apps to enhance the way
`you look. And I think a product like this enables people
`to live up to the persona that they develop online so they
`look as good as they think they do.
`
`Dr. Karpecki: What essential information about the
`MOA of LUMIFY® should be emphasized to our
`colleagues?
`
`Dr. Brujic: The traditional alpha-1 adrenergic receptors
`are extremely selective for the arterial bed. When we think
`about decreasing blood flow into that arterial bed and the
`resulting capillary bed, these alpha-1 receptors are phys(cid:173)
`iologically changing the amount of blood supply that the
`tissue wants in there for a reason. Whereas the alpha-2 ad(cid:173)
`renergic receptor agonists are hyperspecific for the venule.
`And because of that, they're reaching the blood vessels
`that we're seeing; we know that the venules are more
`superficially located. In addition, they're not altering
`
`doesn't slow the exam process down. I turn to make a
`few notes, I turn back, and it's already worked.
`
`Dr. Hauser: I've recorded after installation and just
`watched the eye change, and then showed it to the
`patient, and it's really compelling.
`
`Dr. Karpecki: One of my first patients using LUMIFY®
`Redness Reliever eye drops was a woman who came in
`
`MOA Snapshot of LUMIFY•
`
`LUMIFY® (brimonidine tartrate ophthalmic solution 0.025%):
`
`• Is a selective imidazoline a2--adrenergic receptor (AR)
`agonist12
`
`• Primarily constricts the venules, alleviating the potential
`decrease of blood and oxygen flow through the arteries to
`surrounding tissue, thereby reducing resultant ischemia10,11
`
`• Wrth a relative a2-AR binding affinity 1,000 times greater
`than a1-AR, exhibits a low risk of potential for tachyphy(cid:173)
`laxis or rebound hyperemia as it has minimal action at the
`a1-AR present in the arterioles9·12
`
`In contrast, nonselective vasoconstrictors are commonly
`associated with rebound hyperemia and tachyphylaxis by
`their action on the arteriole, decreasing blood and oxygen
`flow to surrounding tissue,2
`
`Other traditional redness relievers
`
`LUMIF'f'® Redness Reliever eye drops with
`low-dose brimonidine tartrate
`
`8 Review of Optometry I June 2020
`
`Eye Therapies Exhibit 2199, 8 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`REDNESS RELIEVERS
`
`Other OTC redness relievers
`(a1 or a1 /a2-AR agonist)
`
`LUMIFY with low dose Brimonidine
`(Selective a2-AR agonist)
`
`Commonly associated with
`rebound redness and t achyphylaxis
`
`No tachyphylaxis and virtually
`no rebound redness in clinical t rials
`
`Acts on the arteriole,
`decreasing blood and oxygen
`
`LUMIFY selectively constricts the
`venule, while maintaining availability
`
`some of those reasons why
`the eyes remain red.
`
`Dr. Karpecki : In the
`clinical trial looking at
`the safety and efficacy of
`LUMIFY® Redness Reliever
`eye drops, the product ap(cid:173)
`peared safe and effective
`for reduction of ocular
`redness, worked within a
`minute, and lasted up to
`eight hours, with next to
`no rebound hyperemia, no
`evidence of tachyphylaxis,
`and comparable adverse
`events to the vehicle. 2
`
`the blood flow within the tissue. I think that's critically
`important to understand so that clinicians can recommend
`LUMIFY® Redness Reliever eye drops for all the reasons
`that we don't recommend traditional vasoconstrictors.
`
`Dr. Epstein: The eyes are red for a reason, and by re(cid:173)
`ducing the blood flow, this mechanism of action reduces
`
`What ECPs Want to Know About LUMIFY®
`
`Dr. Karpedci: What questions come up the most about
`LUMIFY® Redness Reliever eye drops when you're
`speaking at events and educating other colleagues?
`
`Safety & Efficacy of LUMIFY0 Redness Reliever Eye Drops
`
`In a single-center, double-masked, Phase Ill clinical trial to evaluate the safety and efficacy of brimonidine tartrate
`ophthalmic solution 0.025% for the treatment of ocular redness, adult subjects with baseline redness of more
`than one unit in both eyes (0- to 4-unit scale) were randomized 2:1 to brimonidine tartrate 0.025% or
`vehicle. 2 A single dose was administered in-office (day 1 ); thereafter, subjects instilled treatment four times a day
`for four weeks, with clinic visits on days 15, 29, and 36 (7 days post-treatment). Sixty subjects were randomized
`(n=40 brimonidine tartrate, n=20 vehicle). Here were some of the findings:
`
`• Investigator-assessed redness was lower with brimonidine tartrate vs. vehicle over the 5- to 240-minute post(cid:173)
`instillation period (mean [SE], 0.62 [0.076) vs. 1.49 [0.108); p<.0001) and at each time point within that period
`(p<.0001).
`
`• At 1, 360, and 480 minutes post-instillation, respectively, the mean differences (95% confidence interval)
`between treatments were -0.73 (- 1.05 to -0.41 ), -0.57 (-0.84 to -0.29), and -0.39 (-0.67 to -0.10), respectively.
`
`• No tachyphylaxis was evident with brimonidine tartrate on days 15 and 29, and minimal rebound redness was
`observed following discontinuation.
`
`• The brimonidine tartrate eye drop at 0.025% was rated as very comfortable when used as directed
`
`• Ocular adverse events were also mild when used as directed. Three people experienced four ocular adverse
`events including: itching, tearing, foreign body sensation, and pain at site installation.
`
`Researchers concluded that brimonidine tartrate 0.025% appeared safe and effective for reduction of ocular
`redness, with an 8-hour duration of action, no evidence of tachyphylaxis, and minimal rebound redness.
`
`Sponsored by BAUSCH cl> LOMB
`
`Eye Therapies Exhibit 2199, 9 of 12
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Enhancing
`the Management
`of Red Eye•
`
`Dr. Brujic: Optometrists seem to understand that
`LUM I FY® is safe when used as directed, but there
`tends to be some discrepancies on fully
`understanding the mechanism of action and why
`it is different than those in tradtional redness
`relievers. So helping really crystalize that is important
`so that we can effectively communicate this to our
`patients. The second thing is "What's the dosing on it?
`How many times a day can somebody use it safely?"
`LUMIFY® can be used every six to eight hours and should
`not be used more than four times per day. When patients
`come back and report their experiences with LUMIFY® to
`me, they usually say they used it once or twice a day. My
`patients tend to get a long span of efficacy from a single
`drop, and sometimes they need that second drop later in
`the day, but not frequently.
`
`Dr. Hauser: Across the board, I think eye care providers
`acknowledge the symptoms of dry eye disease, the irrita(cid:173)
`tion, foreign body sensation, and overall dryness. Then a
`smaller subset is starting to acknowledge the visual com(cid:173)
`ponents of it and the blur that comes along with it. And
`then further down the road is the aesthetic component
`and how the eye looks relative to residual redness. But it's
`really all three of those that need to be considered when
`treating the patient.
`
`Dr. Karpecki: The questions I tend to get from physicians
`are regarding intraocular pressure. And we know there
`were no reports of abnormal IOP elevation in the clinical
`trial.2 The other one that comes up is, "I've heard about
`allergies to brimonidine tartrate in the glaucoma concen(cid:173)
`tration. Are you seeing that?" In the clinical trial, we did
`not get any reports of allergic reaction.2 And I'm not see(cid:173)
`ing associated allergies in my patients who use LUM I FY®
`Redness Reliever eye drops.
`
`1, Cronau H, Kankanala RR, Mauger T, Diagnosis and management of red eye in primary
`care. Am Fam Physician. 2010;81(2):137-144.
`2 . Mclaurin E, Cavet ME, Gomes P J, Ciolino JB. Brimonidine ophthalmic solution 0.025%
`for reduction of ocular redness: a randomized clinical trial. Optom Vis Sci. 2018;95(3):264-
`71.
`3 . Coles-Brennan C, Sulley A, Young G. Management of digital eye strain. Clin Exp Optom.
`2019; 102(1 ):18-29.
`4 . Masud M, Moshirfar M, Shah TJ, et al. Eyelid cosmetic enhancements and their as(cid:173)
`sociated ocular adverse effects. Med Hypothesis Oiscov I nnov Ophthalmol. 2019 Sum-
`
`10 Review of Optometry I June 2020
`
`How LUMIFY® Has Helped Strengthen the
`Practice
`
`Dr. Hauser: A lot of my long-term patients are women
`over the age of 40, and they're the medical decision
`makers in their households. If you've got patients excited
`about LUMIFY® Redness Reliever eye drops, then they're
`absolutely going to be the best advocates for your
`practice.
`
`Dr. Karpecki: The patient leaving with whiter-looking
`eyes thinks, "Wow, that doctor really knows what she or
`he is doing." And that patient is more likely to do
`everything else you recommend just because of the
`way their residual redness has improved so quickly.
`
`Dr. Epstein: Anything that we can do to better our
`relationship with our patients, solidify that, and also
`distinguish ourselves and reinforce our therapeutic
`ability is an anchor in turbulent times. So this is a
`significant advantage that we have now.
`
`Dr. Karpecki: I have staff who use LUMIFY® Redness
`Reliever eye drops, so of course that helps-they are
`conveying the excitement that they are experiencing
`with it. But just the impact they see on patients who use
`it, I think, invigorates the staff. And we've rarely had
`opportunities to be able to witness that to such a degree
`as a practice.
`
`Dr. Epstein: LUMIFY® is a practice differentiator. We are
`using LUMIFY® in-office, recommending it, and it's one
`of the few products that we provide in-