[1
`
`go
`
`ige of all the essential‘
`acts.
`
`rmation gives you the
`
`ial data you need.
`
`>111: widespread net-
`lher, organize and
`
`1 a. timely manner.
`
`«re it is published.
`
`Xed for quick,
`ly for fast reference.
`
`Privsici/xns’
`
` DESK
`
`r2EFEi2ENCE
`
`FOR
`OPHTHALMQLOGW
`
`Editorial Consultants and contributors
`clementlll. lllleisbecker, RPh, Director of ‘Pharmacy, wins Eye Hospital,’ Philadelphia, PA
`F.T. Fraunfelder, MD, Director, National Registry of Drug-induced Ocular Side Effects, Oregon Health Sciences University,
`,
`Portland, OR
`Michael Naidoff, MD, Cornea Service, Wills Eye Hospital. Philadelphia, PA
`Douglas Rhee, MD, Wills Eye Hospital, Philadelphia, PA
`Richard Tippermann, MD, Wills Eye Hospital, Philadelphia, PA
`llice Pr-esidentwof
`Services: Stephen B. Greenberg
`Director of Product Management: David P. Reiss
`Senior Product Manager: Mark A. Friedman
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`National Sales Manager: Dikran N. Barsamian
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`Account Managers: Marion Gray. RPh, Lawrence C. Keary,
`Jeffrey F. Pfohl, Christopher N. Schmidt,
`Stephen M. Silverberg, Suzanne E. Yarrow, RN
`National Sales Manager, Trade Group: Bill Gaffney
`Director of Direct Marketing: Michael Bennett
`‘ Direct Marketing Manager: Lorraine M. Loening
`':Promotion Manager: Donna R. Lynn
`; Director, Professional Support Services:
`,
`Mukesh Mehta, RPh
`- senior Drug Information Specialist:
`Thomas Fleming, RPh
`Inc. at Montvale, NJ 076451742. All rights reserved. None of the
`Copyright © 1998 and published by
`content of this publication may be reproduced, stored in a retrieval system. resold, redistributed, or transmitted in any form or by any
`.
`’-
`means (electronic, mechanical, photocopying. recording, or otherwise) without the prior written permission of the publisher. PHYSlClANS‘
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`Eggs’ are registeredtrademarks used herein under license. PDR Companion Guidellll, PDR’ for Herbal Medicinesllll, PDR” Medical Dictionary“,
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`lectronic Library“, and PDR” Drug interactions, Side Effects, indications, Contraindications Systemll“ are trademarks used herein under license.
`iflcers of Medical Economics Company: President and Chief Executive Officer: Curtis E. Allen; Vice President, New Media: L. Suzanne BeDel|:
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`‘
`
`58
`
`1-seaesvzeox
`
`FAMY CARE - EXHIBIT 1013-0001
`
`

`
`ring family of
`00232-7379 or
`
`CONTENTS
`
`Section 1: lndices
`
`1. Manufacturers’ lndex...............
`2. Product Name lndex .................... ..
`
`......................................................................... ..lll
`
`3. Product Category Index ............................................
`4. Active Ingredients lndex..
`
`....................................................... ..Vl
`
`Section 2: Pharmaceuticals in Ophthalmology
`
`in Physicians’
`
`FD&C Act does
`ihysician may us
`5 been approved
`ie it for uses ct
`lations that are
`A also observes
`des drug use th
`g. For products
`3, the publisher
`bing such prod
`have access to
`1d informed deci
`er-the-counter die
`ed that this infor
`he Food and D
`3 are not intend
`iisease.
`
`ampilation, organ
`tron. Each pro
`2 manufacturer,
`Jfacturer's med
`medical consult
`terial
`in Physicia
`e publisher does
`ducts described“
`connection with
`
`herein. Physic!’
`es not assume,
`= obtain and incl
`ivided to it by.
`i that by making_
`advocating the ;
`or
`is the publis
`iue to typograpn
`ry product may‘
`
`A
`
`. Mydriatics and Cycloplegics ..
`. Antimicrobial Therapy ...............................................
`. Ocular Anti-inflammatory Agents ....................... ..
`. Anesthetic Agents ........................................... ..
`. Agents for Treatment of Glaucoma ..................... ..
`. Medications for Dry Eye ......... ..
`. Ocular Decongestants ............................ ..
`. Ophthalmic irrigating Solutions ........
`................
`9. Hyperosmolar Agents
`
`............................. ..
`
`.................................... ..
`.................................. ..
`
`10. Diagnostic Agents ........................................... ..
`11. Viscoelastic Materials Used in Ophthalmology..
`
`.
`12. Off—Labe| Drug Applications in Ophthalmology .......................................... ..
`18. Ocular Toxicology ............................................................................................................ ..19
`
`Section 3: Suture Materials
`
`Section 4: Ophthalmic Lenses
`
`.............................................................................................. ..5O
`2. Aphakic Lenses ...............
`3. Comparison and Conversion Tables ....................
`.................................... ..
`A
`
`Section 5: Vision Standards and Low Vision
`
`Vision Standards.
`t Z Low-Vision Aids .................................................... ..
`
`. Section 6: Evaluation of Permanent Visual Impairment
`
`Cr
`
`iteria and Method
`
`Visual System Impairment Values ..................................................................................... ..68
`Combined Values Chart .................................. ..
`
`.....................
`
`FAMY CARE - EXHIBIT 1013-0002
`
`

`
`Section 7: Product Identification Guide
`
`Page 10
`
`1. index ..............
`
`.............
`
`......................................
`
`..........
`
`........................................ ..1O
`
`2. Full-Color Product Photographs
`
`Section 8: Pharmaceutical and Equipment Product information
`
`Listed alphabetically by manufacturer
`
`'
`
`This section offers f~
`mation you need:
`
`1. Manufacturers’
`_
`_
`participating méinui
`Section 9: lntraocular Product Information
`two page num ers
`—nnnnnnAW------------‘WMW graphsi in'th§ Pi0_<
`.
`and to pro Uct
`I
`Key to Controlled Substances Categories
`addmsses and teie
`headquarters and re
`
`Key to FDA Use—in-Pregnancy Ratings
`
`Ams|er’s Grid
`
`7'
`
`2. Product Namel
`uct information aip
`mond symbol to the
`tograph
`of
`the
`identification Guid:
`page number refer:
`
`PART I/MANUF
`
`moan, INc.
`V2500 Millbrook Driv
`Buffalo Grove, iL BC
`Direct Inquiries to:
`Customer Service
`(800) 5357155
`
`ALGON IABORATOH
`and its Affiliates
`Corporate Headqua
`6201 South Freewe
`, Fort Worth, TX 761
`_ Direct Inquiries to:
`Ophthalmic/Visionc
`(Pharmaceuticals/L
`Surgical: (800) 86:
`(Instrumentation/S
`Systems: (800) 28.
`(Medical Managem-
`Systems)
`
`ALLERGAN . . . . . ..
`2525 Dupont Drive
`P.0. Box 19534
`Irvine, CA 926239
`For Medicai lnfom
`Outside CA: (800)
`CA: (714) 246-45C
`Sales and Ordering
`Outside CA: (800)
`CA: (714) 246~/15C
`
`BAUSCH & LOMB .
`PHARMACEUTM
`8500 Hidden Rive:
`Tampa, FL 33637
`
`FAMY CARE - EXHIBIT 1013-0003
`
`

`
`PHARMACEUWCALS / 13
`WiMvwmmmm w « -~—»»»»»»»»»»»»»»»»»»»»»»»»»»mu.............................................................wk ............................................................................................................................................................,
`
`6. MEDICATIONS FOR DRY EYE
`
`BET/DURATION
`
`,,
`
`_,
`
`=
`
`my eye refers to a deficiency in either the aqueous or
`mucin components of the precorneal tear film. The
`most commonly encountered aqueousdeficient dry
`eye in the United States is keratoconjunctivitis sicca,
`while mucin—deficient dry eyes may be seen in cases
`of hypovitaminosis A, Stevens.-Johnson syndrome,
`ocular pemphigoid, extensive trachoma, and cheml-
`
`Dry eye is treated with artificial tear preparations
`(see Table 20) and ophthalmic lubricants (see Table 21).
`The lubricants form an occlusive film over the ocular
`surface
`and
`protect
`the
`eye
`from drying.
`Administered as a nighttime medication,
`they are
`useful both for dry eye and in cases of recurrent
`corneal erosion.
`
`1
`
`:
`g
`
` % :
`2h/4_5h
`‘
`~-
`
`‘ ARTIFICIAL TEAR PREPARATIONS
`
`» MAJOR COMPONENT(S) Mm
`; Carboxymethylcellulose
`r
`T
`
`CONCENTRATION ("/o)
`0.5%
`
`TRADE NAME
`Refresh Plus
`Celluvisc
`
`““““““““““““““““““““‘KTIMIESERVATIVE/EDTA*
`None
`None
`
`Hydroxyethyl cellulose,
`polyvinyl alcfllgl
`Tl-lydroxypropyl cellulose
`'
`Hydroxypropyl methylcellulose
`‘
`
`,
`
`y
`
`y yyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyy,_MwM_WW_MW
`Lacrisert (biode-
`gradable insert)
`lsopto Plain
`Isopto Tears
`Tearisol
`mm .,.uw......
`lsopto Alkaline
`
`W
`
`.
`
`Hydroxypropyl methylcellulose, ,
`dextran 70
`
`Polycarbophil, PEG-400, dextran 70
`'
`
`Polysorbate 80
`"Polyvinyl alcohol
`.
`
`Polyvinyl alcohol,
`i
`PEG—400, dextrose
`
`iPoIyvlr}yl}iéohol,
`’
`DOVICIOHB
`
`.*EDTA 2 ethylenediaminetetraacetic acid.
`
`"
`
`I‘
`
`.
`.
`
`Bion Tears
`Ocucoat
`Ocucoat PF
`Tears Naturale ll
`Tears Naturale Free
`Tears Renewed
`
`AquaSlte multi—dose
`
`Liquifilm Tears
`
`V
`
`MurineTears
`Refresh
`
`_
`
`s|zE(s)(m1_)
`2.5
`
`7
`
`Sorbic acid, EDTA’
`
`Berlzalkonium chloride
`Benzalkonium chloride
`Benzalkonium chloride, EDTA
`Benzalkonium chloride
`
`Benzalkonium chloride, EDTA
`None
`Polyquad
`,
`A
`None
`Benzalkonium chloride, EDTA
`
`Methyl-, propylparabens
`i=_orA
`
`Chlorobulanol
`Chlorobufanol
`
`Benzalkonium chloride, EDTA
`EDTA
`Benzalkonium chloride, EDTA
`Berlzalkonium chloride, EDTA
`None
`Chlorobutanol
`
`FAMY CARE - EXHIBIT 1013-0004
`
`

`
`/ PDR FOR OPHTHALMOLOGY
`...... MWwMmWMMW ,.M >_4»,,, r..w__e.¢,,_._.,A._.....a,_........«A%
`
`I—"-9-5533
`OPHTHALMIC LUBRlCANT§MM“W
`TRADE NAME
`
`COMPOSITION ofi STERILE oiutilimr
`.0................ ,_.__.wwMd_mw_mmM.%_1
`White petrolatum, liquid lanolin. and mineral oil
`AKVl(A Tears Ointment
`White petrolatum, liquid lanolin, and mineral oil
`
`etrolatum and mineral oil
`White peififiifim, liquid lanolin, and mineral oil
`_ m .mw
`
`P., Lubritears
`
`Laori-Lube
`Puralube
`Refresh P.M., Dry Eyes Lubricant
`
`lanolin alcohol, and chlorobutanol
`5% mineral oil, 55% white petrolatum,
`petrolatum, liquid lanolin, and mineral oil
`41.5% mineral oil, 55% white petrolatum, petrolatum, and lanolin alcohol
`
`7. OCULAR DECONGESTANTS
`
`These topically applied adrenergic medications are commonly used to whiten the eye. Three types are avail- ~
`able. Those containing naphazoline and tetrahydrozoline are more stable than those with phenyiephrine. Usual
`dosage is 1 or 2 drops no more than 4 times a day (see Table 22).
`
`TABLE 22
`
`OCULAR DECONGESTANTS
`
`nnue
`Naphazoline hydrochloride
`
`refine NAME
`
`Oxymetazoline hydrochloride
`
`Phenylephrine hydrochloride
`
`Tetrahydrozoline hydrochloride
`
`Prefrin Liqulfilm
`
`Relief“
`Coilyrlum Fresh
`Murine Plus
`
`...... ...... m ,,mm,.,,,,-
`DECUNGESTANT/ASTHINGENT CDMBINATIDNS
`
`Naphazoline hydrochloride
`‘N plus zinc sulfate
`Phenylephrine hydrochloride
`plus zinc; sulfate
`
`e plus
`*Pi'€:‘SCflDtl0l‘l medicatio .
`
`Clear Eyes ACR
`(allergy/cold relief)
`
`Visine Allergy Relief
`
`Benzalkonium oh oride, edetate disodium
`Benzalkonium ch oride, edetate disodium
`Benzalkonium ch oride, edetate disodlum
`Benzalkonium ch oride, edetate disodium
`Benzalkonium Ch oride, edetate disodium
`Phenylrnercuric acetate
`Benzalkonium oh
`oride, edetate disodium
`Benzalkonium ch
`oride, edetate disodium
`
`Benzalkonium ch
`oride, edetate disodium
`Thlmerosal, edetate disocllum
`Benzalkonium ch
`oride, edetate disodium
`
`Benzalkonium ch
`Benzalkonium ch
`Benzalkonium oh
`
`oride, edetate disodium
`oride, edetate disodium
`bride, edetate disodium
`
`Beiirallionlum ch
`
`edetatedisodiurn
`
`Benzalkonlum ch
`Benzalkonium ch
`
`orrde, edetate disodium
`
`‘ OPHTHA
`
`Listed in Table 23
`general ophthalmic
`oducts. There at
`
`;
`
`gipi-ITHALMIC ll
`rmwmm”
`.l.»w*~"”*"""
`AK~Rinse
`
`Efiifm LFresh—l§ye§_
`
`HYPEROSMOI
`
`GENERTG NAME
`“A. Therapeutic prepa
`‘
`Sodium chloride
`
`-
`
`B. Diagnostic prep;
`Glycerin
`
`FAMY CARE - EXHIBIT 1013-0005
`
`

`
`ALMC RRGATNG SOLUTONS
`
`PHARMACEUTICALS
`
`15
`
`in Tabe 23 are sterile isotonic solutions
`for
`ophthalmic use They are all over1he counter
`irrigating solu
`ucts There
`are also intraocular
`available for use during surgical procedures
`
`prescription medications such
`as
`include
`They
`Lombs Balanced Salt Solution Alcons
`Bausch
`BSS and BSS Plus and blabs
`ocare Balanced
`Salt Solution
`
`23
`
`JHALMC RRGATNG SOLUTONS
`
`COMPONENTS
`
`Sodium potassium calcium and
`magnesium chlorides
`sodium acetate and sodium citrate
`
`Antipyrine boric acid and borax
`
`Sodium and potassium
`
`chlorides and sodium phosphate
`
`Sodium potassium magnesium
`
`and calcium chlorides sodium
`
`acetate and sodium citrate
`
`Boric acid potassium chloride and
`
`sodium carbonate
`
`Sodium chloride sodium biphosphate
`and sodium phosphate
`
`ADDTWNAL
`
`COMPONENTS
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`edetate disodium
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`edetate disodium
`
`Benzalhonium chloride
`
`ium Fresh Eyes
`
`ose
`
`tik Eye Wash
`
`HYPEROSMOLAR AGENTS
`
`erosmobar hypertonic agents are used to reduce corneal edema therapeutically or for diagnostic purposes
`corneal epithelium
`through the semipermeable
`through osmotic attraction of water
`
`act
`
`LE 24
`
`PEROSMOLAR AGENTS
`
`RC NAME
`
`erapeutic preparations
`
`chloride
`
`TRADE NAME
`
`Adsorbonac Ophthalmic
`AKNaCl
`
`Muro-128
`
`Diagnostic preparation
`
`Glycerin
`
`Ophthalgan
`
`CONCENTRA11ON
`
`2% or 5% solution
`5% solution and ointment
`2% or 5% solution
`5% ointment
`
`bcohol and chlorobutanob
`
`and lanolin alcohol
`
`Three types are avai
`U5L
`ith phenylephrine
`
`MPONENTS
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`icetate
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`ate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride
`
`bride edetate disodium
`
`FAMY CARE - EXHIBIT 1013-0006
`
`

`
`16
`PDR FOR OPHTHALMOLOGY
`10 DAGNOSTC AGENTS
`
`Some of the more common diagnostic
`tests used in ophthalmologic
`practice
`below
`
`agents and
`are hsted
`
`Examination of the Conjunctiva Cornea
`and Lacrima Apparatus
`2% alkaline solu
`Fluorescein applied primarily as
`tion and with impregnated
`paper strips is used to
`examine
`the
`the
`and
`conjunctival
`integrity of
`corneal epithelia Defects in the corneal epithelium
`wifi appear bright green in ordinary light and bright
`is used in the light
`yellow when
`cobalt blue filter
`path Similar
`lesions of
`the conjunctiva
`appear
`bright orange-yellow in ordinary illumination
`
`Fluorescein has also come into wide use in the fit
`lenses though it cannot
`be
`rigid contact
`ting of
`used for soft
`lenses which absorb the dye Proper
`is determined by examining the pattern of fluo
`lens
`rescein beneath the contact
`
`fit
`
`In addition fluorescein is used in performing appla
`nation tonometry and one test of
`lacrimal appara
`drop of 1% fluo
`tus patency Jones test uses
`sac If the dye
`rescein instilled into the conjunctival
`in the nose drainage is normal.1
`
`appears
`
`1% solution is particularly use
`Rose bengal as
`for demonstrating abnormal
`conjunctival
`or
`ful
`corneal epithelium Devitalized
`cells stain
`bright
`red while normal cells show no change The abnor
`mal epithelial cells present
`in dry eye disorders are
`revealed by this stain
`
`effectively
`
`is
`
`valuable method of assess
`The Schirmertest
`ing tear production It employs prepared strips of
`by 30 mm in size The strips are
`filter paper
`inserted into the topically anesthetized conjunctival
`of the middle and outer
`sac at the junction
`third of
`lid with approximately 25 mm of paper
`the lower
`exposed After minutes the strip is removed and
`the amount of moistening measured The normal
`range is 10 to 25 mm If
`inadequate production
`of
`tears is found on the initial
`test
`Schirmer II test
`can be performed by repeating the procedure while
`number of varia
`stimulating the nasal mucosa.2
`tions of
`the Schirmer test can
`be found in text
`books and journals
`
`Examination of Acquired Ptosis or
`Extraocular Musde Pasy
`gravis as the cause of pto
`To confirm myasthenia
`sis or muscle oalsv an intravenous
`inlection of
`mg of edrophonium chloride is administered fol
`mg if
`lowed 45 seconds
`later by an additional
`there is no response to the first dose In case of
`severe reaction to the edrophonium immediate
`ly give atropine sulfate 0.6 rng intravenously
`
`Examination of the Retina and Choroid
`Sodium tluorescein solution in concentrations of 5%
`10% and 25% is injected intravenously to study the
`
`retinal and choroidal circulation It has been used pri
`marily in examination of lesions at the posterior pole
`of the eye but anterior segment
`fluorescein angiog
`raphy wherein the vessels of the iris sciera and con
`junctiva are studied is also
`useful clinical
`tool
`
`is normally prevented from
`Intravascular
`fluorescein
`vascular
`entering the retina by the intact
`retinal
`endotheliurn blood-retinal barrier and the intact reti
`nal pigment epithelium Defects in either the retinal
`vessels or the pigment epithelium will allow leakage
`of fluorescein which
`can then be studied by either
`direct observation or photography For good results
`to excite the fluores
`appropriate filters are needed
`The peak
`cein and exclude unwanted wavelengths
`frequencies for excitation lie between 485 and 500 nm
`and for emission between 520 and 530 nm
`
`safe diagnostic agent
`Fluorescein has proved to be
`the most common side effects
`being nausea and
`vomiting However occasional allergic and vagal
`reac
`tions do occur so oxygen and emergency equipment
`should be readily available when angiography is per
`formed Patients should also be warned that
`the dye
`temporarily stain their skin and urine in the aver
`this lasts no more than
`day
`age patient
`
`will
`
`Indocyanine green IC-Green has been used in recent
`years either alone or with fluorescein to obtain bet
`ter frames of choroid neovascularization
`
`conjunctival
`
`Examination of Abnorma Pupiflary Responses
`2.5% solution instilled into the
`as
`Methacholine
`cause the tonic pupil Adies
`sac will
`but will
`leave
`normal
`to contract
`pupil
`pupil
`unchanged
`similar pupillary response is seen fol
`lowing instillation of 2.5% methacholine
`in patients
`with familial dysautonomia Riley-Day syndrome
`Tabe 25 shows the effects of several drugs on mb
`sis due to interruption
`the sympathetic
`system
`of
`Homers syndrome The effect depends on the location
`of the lesion in the sympathetic chain
`
`TABLE 25
`
`HORNERS SYNDROME
`
`NEURON
`
`IN
`
`POST-
`GANGUONIC
`
`II
`
`NEURON
`PR
`GANGUONIC
`
`NEURON
`
`TOPICAL DROP
`CENTRAL
`Cocaine 2%10%
`
`Epinephrine
`Adrenalin 11 000
`
`Phenylephrine
`
`1%
`
`rpine may be use
`is due to
`hated pupil
`iption of the pupils
`atropine-like drug
`act to pilocarpine
`the parasympatheti
`neurysm Adies tor
`pine will cause the
`
`If
`
`VSCOE
`
`iscoelastic
`
`substam
`urgery to maintain th
`sect
`tissues act
`Ic and prevent mect
`endc
`the corneal
`
`ially
`eristics of the various
`esult of the chain Ien
`cular
`interactions of
`scoelastic substance
`to produc
`they an
`pressure if
`1he anterior chamber
`
`potential
`
`1VISC Chiron Vision
`sodium hyaluronate
`osity is 40000
`end molecular weigh
`life is estimatec
`3helf
`
`MVISC PLUS Chiror
`omposed of sodium
`The viscosity
`rate and mo
`hear
`1500000 daltons
`by increasing total
`aluronate of lower
`timated at
`
`year
`
`UOVISC Alcon
`yringes One syringe
`ining Viscoat PIe
`low for details of Ci
`
`HEALON Pharmacia
`ialuronate 1% in ph
`00000
`0/sec
`is approximatE
`
`OFFLAJ
`
`Acetylcysteine
`is used to
`This agent
`Ikali burns cornea
`icca It
`is thought tc
`tion of collagen ase
`aling The drug is
`name Mucom
`none of the
`oved for use
`ninistered as frec
`times
`up to
`
`FAMY CARE - EXHIBIT 1013-0007
`
`

`
`fixed
`
`pilocarpino may be used to determine whether
`is due to an atropine-like drug or inter
`dilated pupil
`rnnervation If
`ruptiOn of the pupils parasympathetic
`an atropine-like drug is involved the pupil will not
`If dilation is due to interruption
`react to pilocarpine
`innervation compression by
`of the parasympathetic
`aneurysm Adies tonic pupil
`instillation
`of pilo
`carpine will cause the pupil to constrict
`
`PHARMACEUTICALS
`
`17
`
`REFERENCES
`
`Thompson HS Mensher JH Adrenergk mydnsis in
`Homers syndrome hydroxyarnpheta mine test for diagno
`OphthamO 197172472
`defects.Am
`of postgariglionio
`Hecht SD Evaluation ofthe lacrimal drainage system
`
`ThompsonHsNewsomeDALowenfeld
`pupil Sudden iridoplegia or mydriatic drops
`
`diagnostic test Arch Ophthaimol 1971
`
`simple
`
`The fixed dilated
`
`11 VISCOELASTIC MATERIALS USED IN OPHTHALMALOGY
`
`Viscoelastic
`
`are used in ophthalmic
`substances
`surgery to maintain the anterior chamber hydraulically
`vitreous substitute/tampon-
`tissues act as
`dissect
`damage
`ade and prevent mechanical
`to tissue espe-
`endothelium The individual charac-
`cially the corneal
`teristics of the various viscoelastic materials are the
`result of the chain length and intra and interchain mol
`interactions of the compounds comprising the
`ecular
`viscoelastic substance All viscoelastic materials have
`large postoperative increase
`the potential to produce
`they are not adequately removed from
`in pressure if
`the anterior chamber following surgery
`
`AMVISC Chiron Vision Bausch and Lomb
`Composed
`of sodium hyaluronate 1.2% in physiologic saline The
`viscosity is 40000 cSt @25
`shear rate
`1/sec
`2000000 daltons Its
`and molecular weight
`is estimated at
`years
`shelf life
`
`is
`
`and Lomb
`AMVISC PLUS Chiron Vision
`Bausch
`composed of sodium hyaluronate 1.6% in physiologic
`saline The viscosity is 55000 cSt @25
`1/sec
`shear rate and molecular weight
`is approximately
`1500000 daltons The greater viscosity is obtained
`and using sodium
`by increasing total concentration
`hyaluronate of lower molecular weight
`Its shelf
`life
`is
`estimated at
`year
`
`DUOVISC Alcon
`two
`contains
`separate
`Package
`syringes One syringe containing Provisc the othercon
`taming Viscoat Please see individual descriptions
`below for details of each
`
`Composed of sodium
`HEALON Pharmacia
`Upjohn
`hyaluronate 1% in physiologic saline The viscosity is
`rate and the molecular
`200000
`shear
`0/sec
`is approximately 4000000 daltons
`weight
`
`Composed of
`UpJohn
`HEALON GV Pharmacia
`sodium hyaluronate 1.4% in physiologic saline The vis
`0/sec shear rate and the mol
`cosity is 2000000
`IS approximately 5000000 daltons In
`ecular weight
`the presence
`high positive vitreous pressure
`of
`Healon GV has three times more resistance to pres
`sure than does Healon
`
`Bausch and Lomb Composed of
`OCCUCOAT Storz
`hydroxypropylmethylcellulose 2% in balance salt solu
`ton BSS The viscosity is 4000 cSt
`mew
`37
`sured on Cannon-Fenske Viscometer and the molec
`ular weight is approximately 80000 daltons Occucoat
`is termed
`viscoadherent
`rather than
`viscoelastic
`its coating ability which
`because of
`is related to its
`contact angle and low surface tension
`
`Composed of sodium hyaluronate
`PROVISC Alcon
`1% in physiologic saline The viscosity is 39000 cps
`25
`2/sec shear rate and the molecular weight
`is approximately 1900000 daltons Clinical studies
`similar fashion
`demonstrate that ProViso functions in
`to Healon
`
`Composed of 13 mixture of chon
`VISCOAT Alcon
`droitin sulfate 4% CS and sodium hyaluronate 3%
`SH in physiologic saline The viscosity is 40000 cps
`25
`2/sec shear rate and the molecular weight
`is 22500 daltons for CS and 500000 daltons for SH
`
`Composed of sodium hyaluronate
`VITRAX Allergan
`salt solution BSS The viscosity is
`3% in balanced
`30000 cps
`2/sec shear rate and the molecular
`is 500000 daltons It
`is highly concentrated to
`weight
`significantly viscous material
`It does not
`produce
`life of 18 months
`require refrigeration and has
`shelf
`
`12 OFF-LABEL DRUG APPLICATIONS IN OPHTHALMOLOGY
`
`been used pri
`p01
`posterior
`rescein angiog
`sclera and con
`ical tool
`
`prevented from
`etinal vascula
`
`the intact
`
`ret
`
`ither
`
`the retina
`
`II allow leakag
`udied by eithe
`Dr good results
`cite the fluore
`gths The
`pea
`85 and 500
`530 nm
`
`iagnostic agent
`ng nausea an
`and vagal
`rea
`ency equipmen
`iography is pe
`ied that the dy
`rine in the ave
`day
`
`used in rece
`to obtain be
`
`tion
`
`ry Responses
`nstilled into th
`-lic pupil Adie
`normal
`pup
`nse is seen fol
`oline in patien
`syndrome
`
`al drugs on mi
`pathetic
`syste
`1s on the Iocatio
`in
`
`NIC NEURON
`
`Acetylcysteine
`is used to treat corneal conditions such as
`This agent
`aikali burns corneal melts and keratoconjunctivitis
`to improve healing by inhibiting the
`Sicca It
`is thought
`action of collagenase which may contribute to delay in
`healing The drug is available generically or under the
`in 10% and 20% solutions
`trade name Mucomyst
`Though none of the commercially available solutions
`for use in ophthalmology they have been
`are approved
`administered as frequently as hourly in acute cases
`and up to
`day in maintenance therapy
`times
`
`is
`
`patients
`
`initial
`
`Alteplase tissue plasminogen activator
`trade-named Activase
`thromboltic
`agent
`This
`used to treat
`fibrin formation in postvitrectomy
`studies were based
`Though
`on
`injections of 25 pg more recent work has
`intraocular
`shown the drug to be effective in doses of as little
`as
`Jg Because by products of alteplase activity
`to
`may mediate endothelial cell toxicity the lower doses
`are preferred This agent has also been used frr sub-
`macular hemhorrage but this use is controversial
`
`FAMY CARE - EXHIBIT 1013-0008
`
`

`
`he more recently t
`effects of drugs in 3
`
`it is not a catalog of
`
`The volume of ocul:
`ture is overwhelm]
`gait data, since,
`ll
`patients on a Patti‘
`an adequate sampl
`tal environment, it
`andeffect relation:
`multitude of varial:
`impossible. It was
`National Registry 0'
`was founded.
`
`Established by _
`Administration. Wli
`
`18 / PDR FOR OPHTHALMOLOGY
`
`C. Antimetabolites
`
`5~F/uorouracil (5-FU). This drug inhibitsrfibroblasts
`and therefore diminishes scarring after glaucoma fil-
`tering surgery.
`lnitial
`recommendations called for
`subconjunctival
`injection of 5 mg twice daily for
`7 days postoperatively and once daily for the suc-
`ceeding 7 days. However, many physicians today are
`achieving positive results with as little as 4 mg
`administered 4 to 6 times during a 10-day period.
`Use of this drug is associated with a number of com
`plications, including conjunctival wound leak, corneal
`epithelial defects, hypotony associated with perma-
`nently reduced vision acuity, serious corneal
`infec-
`tions in eyes with preexistent corneal epithelial
`edema, and increased susceptibility to lateonset
`bleb infections. The drug should be considered only
`when there is a high risk of surgical failure.
`Mitomycin. This potent chemotherapeutic agent,
`trade-named Mutamycin,
`is being used in filtering
`surgery for the same purpose and on the same type
`of patients as 5-FU. it is applied once during surgery
`on a small piece of Gelfilm or Weck Cell in a concen-
`tration of 0.2 to 0.4 mg/mL. Reported side effects
`are similar to those of 5-FU. However, some serious
`side effects may go unreported, since there is a pos-
`sibility of delayed reactions 6 to 24 months after
`surgery. Mitomycin has also been administered in a
`0.02% to 0.04% solution 2 to 4 times a day to pre-
`vent recurrence after pterygium surgery. Serious side
`effects associated with this therapy include corneal
`melts and scleral ulceration and calcification.
`Physicians should bear in mind the possibility of
`major side effects from all antineoplastic agents and
`carefully weigh the risks and benefits of the use.
`Remember, too, that these agents should always be
`handled and discarded in accordance with OSHA,
`AMA, ASHP, and/or hospital policies regarding the
`safe use of antineoplastics.
`D. cyclosporine
`
`This potent immunosuppressant has a high degree of
`selectivity for T lymphocytes. Available under the
`trade name Sandimmune, it has been used in a 2%
`topical solution as prophylaxis against rejection in
`high—risk, penetrating keratoplasty and for treatment
`of severe vernal conjunctivitis resistant to more con-
`ventional
`therapy,
`ligneous conjunctivitis unrespon-
`sive to other
`topical
`therapy, and noninfectious
`peripheral ulcerative keratitis associated with sys-
`temic autoimmune disorders. All contraindications for
`systemic use also apply to topical administration,
`since blood levels of up to 64 ng/mL have been
`observed after topical application. All patients receiv-
`ing this medication should have blood work that
`includes cyclosporine levels, blood urea nitrogen, cre-
`atinine, lactate dehyrogenase, alkaline phosphatase,
`and total bilirubin.
`E. Doxycycline
`This derivative of tetracycline is used for the treatment of
`ocular rosacea and meibomianitis. The usual dose is 100
`mg PO daily for a 6 to 12 week course of treatment. it has
`the same side effects, contraindications, and interactions
`as tetracycline.
`
`F. Edetate dlsodium
`This chelating’ agent plays a role in the treatment of band
`keratopathy. After removal of the corneal epithelium, it is
`used to remove calcium from Bowman's membrane.
`
`iiE'I?€fz"E"fii:”E§""""""'""”””""-"”"“ iiiiiiiiiiii'""""M""
`
`Nesburn A. Trauma topics: small corneal perforations. Audio Digest.
`Ophthalmol. 1983;1.2:21.
`in: Tasman W, Jaeger E, eds,
`Ralph R. Chemical burns of the eye.
`Duane's Clinical Ophthalmology, Philadelphia, Pa: JB Lippincott:
`1989 vol. 4, chap 28:14.
`Jaffe G, Abrams G, et al. Tissue plasminogen activator for post
`vitrectomy fibrin formation. Opthalma/ogy. 1990;97:189.
`McDermott M, Edelhauser H, et al. Tissue plasminogen activator
`and corneal endotiielium. Am J Ophthalmol. 1989108.
`Williams D, Benett S, et al. Low-dose intraocular tissue plasminogen
`activator for treatment of postvitrectomy flrbrin formations.
`Am J Optha/moi. 1990;109:606.
`Williams G, Lambrou F, et al. Treatment of postvitrectomy fibrin
`formation with intraocular tissue plasminogen activator.
`Arch Ophthalmol. 1988;106:1055.
`Ando H, Tadayoshi I, et al. inhibition of corneal epithelial
`wound healing. A comparative study of mitomycin C and
`5'-fiuorouracil. Ophthaimoiogy. 1992;99:1809.
`Falck F, Skuta G. Klein T. Mitomycin versus 5~fluorouracil
`antimetabolite therapy for glaucoma filtration surgery.
`Semin in Ophthaimoi. 1992:7297.
`Who should receive antimetabolites after filtering surgery?
`Arch Ophthalmol. 1992;110:1069. Editorial.
`Welsh R, Palmer 8. Mitomycin in trabeculectomy: alter your
`technique. Ocular Surgery News. May 1, 1992167.
`Dunn J, Seamone S, Ostler H. Development of sclerai ulceration and
`calcification after pterygium excision and mitomycin therapy.
`Am J Ophthalmol. 1991;112:343.
`Rubinfeld R, Pfister R, et al. Serious complications of topical
`mitomycin-C after pterygium surgery. Ophthalmology.
`1992;99:1647.
`Bonomi L. Medical treatment of glaucoma. Current Science.
`1992::l.040:70.
`Lish A, Camras C, Podos 8. Effect of apraclonidine on lntraocular
`pressure in glaucoma patients receiving maximally tolerated
`medications. Glaucoma. 1992;1:19.
`Holland E, Chan 0, et al. lmmunoh tologic findings and results of
`treatment with cyclosporine in ligneous conjunctivitis.
`Am J Ophthaimol. 1989;107:160.
`Bouchard C, Belin M. Letter to Editor concerning above article, with
`reply by author. Am J Ophthalmol. 1989;108:210.
`Secchi A, Tognan M. Leonardl A. Topical use of cyclosporine in the
`treatment of vernal conjunctivitis. Am J Ophthalmol.
`1990;110:641.
`BenEzra D, Matamoros N, Cohen E. Treatment of severe vernal
`keratoconjunctivitis with Cyclosporine A eyedrops.
`Transplant Proc. 1988;20,No.2(suppl 2):644. ‘
`,
`Zierhut I-l, Thiel E, et al. Topical treatment of severe corneal ulcers
`with cyclosporine A. Graefe’s Arch Clin Exp Opthalmoi.
`1989;227:30.
`Hill J. The use of cyciosporin in high-risk keratoplasty.
`‘ Am J Ophtha/moi. 1989;107:506.
`Belin M, Bouchard C, Frantz S, et al. Topical cyclosporine in high—risk
`corneal transplants. Ophthalmology. 1989;923:1144.
`Quarterman MJ, et al. Signs, symptoms, and tear studies before
`and after treatment with doxycycline. Arch Dermatol. 1997;
`133:89.
`Frucht-Perry J, et al. The effect of doxycycline on ocular rosacea.
`Am J Ophthalmol. 1989;170(4):434.
`
`FAMY CARE - EXHIBIT 1013-0009