we
`
`An Advance in Redness Reduction:
`
`Brimonidine Tartrate 0.025%
`
`BAUSCH +LOMB
`
`LUMIFY® Redness
`Reliever Eye Drops
`
`LUMIFY
`Lar
`NEoesDe
`iaasd Sasdada
`
`paar arA.
`eeCErs
`
`LUMIFYis a trademark of Bausch & Lomb Incorporatedorits affiliates.
`© 2021 Bausch & LombIncorporatedorits affiliates. LUM.0205.USA.21
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 1 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`An Advance in Redness Reduction:
`
`Brimonidine Tartrate 0.025%
`
`BAUSCH +LOMB
`
`LUMIFY® Redness
`Reliever Eye Drops
`
`LUMIFY
`Lar
`NEoesDe
`iaasd Sasdada
`
`paar arA.
`eeCErs
`
`LUMIFYis a trademark of Bausch & Lomb Incorporatedorits affiliates.
`© 2021 Bausch & LombIncorporatedorits affiliates. LUM.0205.USA.21
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 1 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Y)
`
`Y)
`
`Y)
`
`Y)
`
`Dr. Toyos is a paid speaker presenting on behalf of Bausch + Lomb.
`
`Bausch + Lomb is the sponsorof this program and event.
`
`The content of this promotional slide deck and program was developed by Bausch + Lomb
`and is consistent with FDA and otherapplicable guidelines.
`
`This is not a continuing medical education (CME) or continuing
`education (CE) event, and no CME or CEcredit will be provided.
`
`B A U Ss Cc te + LO eM B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 2 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Rationale for Development
`
`Brief History of Brimonidine
`
`ProductProfile
`
`Mechanism of Action
`
`US Clinical Development Program
`Oo
`Phase 2
`
`Q)
`
`@ @ Q
`
`)
`
`Q)
`
`©s—Phase 3 (BL861)
`
`©s—Phase 3 Safety Study (BL862)
`
`Y)
`
`Summary
`
`B A U Ss Cc 7) . LO PA B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSESONLY.
`
`Eye Therapies Exhibit 2052, 3 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Rationale for Development of LUMIFY® Redness Reliever Eye Drops
`
`agonists
`
`Historically, OTC vasoconstrictors are a1- or
`mixed a1-/a2-adrenergic receptor (a-AR)
`
`©
`
`Selective a1-AR agonists (phenylephrine,
`tetrahydrozoline)
`
`© Mixed a1/a2-ARagonists (naphazoline,
`oxymetazoline)
`
`©
`
`Long-term use wasgenerally restricted by
`tachyphylaxis, rebound redness, mydriasis and
`systemic adverse events (e.g. somnolence,
`dizziness)14
`
`Tachyphylaxis associated with
`internalization/downregulation of a1-ARs
`
`Rebound rednessassociated with
`vasoconstrictor-induced tissue ischemia
`
`B A U Ss Cc te + LO eM B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 4 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Brief History of Brimonidine
`
`QO)
`
`Brimonidine Tartrate is a selective a2-AR agonist
`
`C)
`
`Usedtopically as Rx ophthalmic at concentrations >0.1% for lowering IOP in patients
`
`with OAG or OHT?*
`
`©
`
`©
`
`Acts on iris-ciliary body a2-ARs to lower IOP by reducing aqueous humorproduction?
`
`Also increases uveoscleral outflow over longer-term?
`
`C)
`
`Usedtopically as Rx dermalat 0.33% (gel) for treatment of persistentfacial erythema of
`
`rosacea‘
`
`QO) Dose-dependenteffect on conjunctival blood vessels
`
`©
`
`©
`
`High doses > associated with hyperemia
`
`Low doses > associated with conjunctival ‘whitening or blanching’®
`
`B A U Ss Cc 7) . LO PA B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSESONLY.
`
`Eye Therapies Exhibit 2052, 5 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Product Profile
`
`
`
`FDA Approved Use
`
`.,
`_
`DT d=teidelay
`
`
`
`Brimonidine Tartrate (0.025%) drop — OTC NDA
`
`Relieves redness of the eye due to minoreyeirritations
`
`Adults and children 5 years of age and over:Instill 1 drop in the affected eye(s)
`.
`:
`every 6-8 hours. Do not use morethan 4 timesdaily.
`
`Selective a2-AR agonist with minimal action at a1-AR
`
`-
`.
`.
`Warnings
`Inactive ingredients
`For ator use only
`Do not use
`nzalkon
`r
`Br
`0.
`Donotuse|©.benzalkonium chloride, boric
`@ if solution changes color or becomes cloudy
`acid, calcium chloride
`N
`NI
`H
`Stop useandask adoctorIf
`dihydrate,glycerin, potassium
`ST
`im you experience eye pain, changes In vision, continued
`chloride, sodium borate
`redness or irritation of the eye
`decahydrate, sodium chloride,
`@ condition worsensorpersists for more than 3 days
`water forinjection.
`If pregnant or breast-feeding, ask a health professional
`Hydrochloric acid and/or
`before use,
`sodium hydroxide may be used
`Keepout of reachof children. If swallowed, get medical help
`to adjust pH.
`
`H
`
`HO
`
`Zz
`
`ou
`.
`Brimonidine Tartrate
`
`H
`
`O
`
`OH
`
`orcontact a Polson Control Center right away.
`
`B A U Ss Cc te + LO eM B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 6 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Mechanism of Action Video
`
`
`
`B A U Ss Cc te . LO eM B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 7 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`US Clinical Development Program
`
`Six clinical studies were conductedto assessthe safety
`and efficacy of Brimonidine Tartrate (0.025%)
`
`Slayback v. Eye Therapies - IPR2022-00142
`
`igenocn ronvistninurion. FOR PRESENTATION PURPOSESONLY. SSS
`Eye Therapies Exhibit 2052, 8 of 24
`
`BAUSCH *#LOMB
`
`
`
`
`
`Phase 2 Study
`
`
`A Single-Center, Randomized, Double-Masked, Place
`Controlled, Dose-Ranging Evaluation of the Duration
`Brimonidine Tartrate Ophthalmic Solution in the Preve
`Redness Induced by Conjunctival
`Allergen Challenge (CAC)
`
`B A U S Cc I ; L oO RA B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FOR DISTRIBUTION; FOR PRESENTATION PURPOSESONLY.
`
`Eye Therapies Exhibit 2052, 9 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 2 Study Design
`
`QO)
`
`Purpose:
`°|
`
`
`
`
`
`
`
`NFIDENTIAL—DO NOT PRINT
`
`ORCOPY—THESE MATERIALS ARE FOR YOURVIEWING ONLY AND ARE NOT
`
`Eye Therapies Exhibit 2052, 10 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 2 Efficacy
`
`
`SONY.
`
`| ees at
`
`Eye Therapies Exhibit 2052, 11 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Before and After LUMIFY
`
`
`
`ee
`
`Photos courtesy of Kentucky Eye Institute
`
`Eye Therapies Exhibit 2052, 12 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 2 Safety
`
`0 e
`
`e0 EE
`
`0iee
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`©iEee
`
`BAUSCH +LOMB CONFIDENTIAL — D0NOTPRINT OR COPY — THESE MATERIALS ARE FOR YOURVIEWINGONLY ANDARE NOT
`INTENDEDFOR DISTRIBUTION; FOR PRESENTATION PURPOSES ONLY
`
`[13]
`Eye Therapies Exhibit 2052, 13 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Phase 3 Study (BL861)
`
`
`A Single-Center, Double-Masked, Randomiz
`Vehicle-Controlled, Parallel-Group Study Evaluating the
`m
`of Brimonidine Tartrate Ophthalmic Solution 0.025% Us
`Daily in a Population of Adult and Geriatric Subjects Wit
`
`B A U S Cc I ; L oO RA B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FOR DISTRIBUTION; FOR PRESENTATION PURPOSESONLY.
`
`Eye Therapies Exhibit 2052, 14 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Study Design (BL861)
`
`QO)
`
`Purpose:
`
`
`
`CONFIDENTIAL — DO NOT PRINT OR COPY— THESE MATERIALS ARE FOR YOUR VIEWING ONLYAND ARE NOT
`BAUSCH +LOMB INTENDEDFOR DISTRIBUTION; FOR PRESENTATION PURPOSESONLY
`
`Eye Therapies Exhibit 2052, 15 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Efficacy (BL861) — Clinician Redness Score
`
`Eye Therapies Exhibit 2052, 16 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Efficacy (BL861) — Patient Diary Assessments
`
`
` are
`
`Eye Therapies Exhibit 2052, 17 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Safety (BL861)
`
`BA U S Cc H + LO M B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY
`
`Eye Therapies Exhibit 2052, 18 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Phase 3 Safety Study (BL86:
`
`
`A Multi-Center, Double-Masked, Randomized, Vehicle-Cc
`Group Study Evaluating the Safety of Brimonidine Tartre
`Solution 0.025% Used Four Times Daily in a Population c
`and Geriatric Subjects
`
`B A U S Cc I ; L oO RA B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FOR DISTRIBUTION; FOR PRESENTATION PURPOSESONLY.
`
`Eye Therapies Exhibit 2052, 19 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Safety Study Design (BL862)
`
`QO)
`
`QO)
`
`Purpose
`
`°
`
`Design
`
`BMHo
`
`
`
`NFIDENTIAL — DO NOT PRINT
`OR COPY — THESE MATERIALS ARE FOR YOURVIEWING ONLYAND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSESONLY
`
`Eye Therapies Exhibit 2052, 20 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`Phase 3 Safety (BL862)
`
`0 hmm
`
`°vu;
`
`
`
`BA U S Cc H + LO M B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDEDFOR DISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 21 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Phase 3 Safety (BL862) — Continued
`
`
`
`tl |
`
`*MedDRA coding dictionary (version 16.1)
`
`B A U S Cc H + LO M B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY
`
`Eye Therapies Exhibit 2052, 22 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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`@
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`BA U S Cc H + LO M B
`
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY ANDARE NOT
`INTENDEDFOR DISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`Eye Therapies Exhibit 2052, 23 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`
`
`
`
`
`
`Thank You
`
`Sterile
`
`CTars
`MULE) yeh
`REDNESS RELIEVER EYE DROPS
`
`® Worksin 1 minute
`
`® Lasts up to 8 hours
`
`
`B A U & Cc et
`‘ L oO re B
`CONFIDENTIAL — DO NOT PRINT OR COPY — THESE MATERIALS ARE FOR YOUR VIEWING ONLY AND ARE NOT
`INTENDED FORDISTRIBUTION; FOR PRESENTATION PURPOSES ONLY.
`
`4
`ad
`Eye Therapies Exhibit 2052, 24 of 24
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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