September 1, 2013
`VOL3a,H0.17
`
`C L I N I C A L N E W S
`
`& ANALYSIS
`
`~ GLAUCOMA + POINT/COUNTERPOINT 'IDEAL: DMETHERAPY
`
`t
`T e
`lmes AovANcEsorrJ MYOPIC LASIK WFG ABLATIONS
`SLT as standard for
`first-line lOP lowering
`
`I~ OphthalmologyTimes.com
`
`FOLLOW US ONLINE: ~~ c
`
`THE ELEMENTS
`OF SUCCESS
`By Peter f. McDonnell, MD
`
`The country of Brazil has changed dra
`matlcally In the past two decades. After
`emerging from a military government,
`successive democratically elected f!JV
`emments have overseen dramatlceco
`nomic growth Brazil Is 5th or 6th In
`terms of gross domestic product with
`an unemployment rate lower than the
`United States, plus the emergence of
`an extremely large middle class. With
`this success comes greater demand
`for health care services.
`My friend, Mauro, Is anophthalmolo
`gist In the largest city (by population)
`In the Western Hemisphere.
`(See story on page 4 : Editorial )
`
`3 STRATEGIES
`FOR TRAUMATIC
`CATARACT
`
`DURHAM, NC :: MANAGING TRAU·
`MATIC CATARACTS In children requires
`attention to three Issues when Implant
`lng an IOL: the timing of the lmplanta
`tlon, the lens type, and the IOL calcu
`lations, said Edward G. Buckley MD.
`However, there are several controversies
`regarding IOL Implantation In children.
`(See story on page 30 : Traumatic )
`
`Large retrospective
`analysis supports
`approach for
`reducing pressure
`with durable benefit
`
`By Cheryl Guttman Krader;
`Reviewed by Lawrence R Jindra, MD
`
`NEW YORK::
`'IHE SUCCFSS OF SELECTIVE LASER
`trabeculoplasty (SL T) as a primary therapy for glau
`coma is supported by a review of a large series of
`eyes with long term follow up.
`The analysis included data from 1,983 eyes identi
`fied from a consecutive series of 4,048 eyes treated
`with SLT over a period of 10 years. Suggested prac
`tice guidelines were used from the American Acad
`emy of Ophthalmology, the Glaucoma Laser Trial,
`the Ocular Hypertension Treatment Study (OHTS),
`and the Early Management of Glaucoma Trial.
`All patients had a minimum follow up of 2 months.
`Average follow up for the 1,983 eyes was 917 days.
`Mean IOP was 18.1 mm Hg prior to SLT, and it
`decreased to 12.8 mm Hg ( 29%) at last follow up.
`( Continues on page 21 : SLT)
`
`PAGE 1 OF40
`
`SENJU EXHIBIT 2222
`INNOPHARMA v SENJU
`IPR2015-00903
`
`

`
`PAGE20F40
`
`sit -ellex.com/USA
`
`

`
`SEPTEMBER 1. 2013 ·· Ophthalmology T1mes
`
`Ophthalmology Times
`
`COntentS
`
`3
`
`2 pl/nin + 60 bpm • 0.03 111/ sec
`
`t
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`... ~":~~·-~ ):··:!).
`.,
`~-
`
`' •
`
`-
`• • SURGICAL TECHNIQUE
`
`-
`
`Neuro-Ophthalmology
`24 TRACKING VISUAL LOSS
`IN MULTIPLE SCLEROSIS
`Time-domain Ocr used to determine
`if thinning of RNFL continued
`
`Cataract
`30 3 STRATEGIES FOR
`TRAUMATIC CATARACT
`Timing, IOL type, and lens calculations
`are important for pediatrics
`
`Retina
`28 POINT: LASER TREATMENT
`NECESSARY FOR DME
`Subthreshold micropulse laser preferred
`over conventional laser
`
`29 COUNTERPOINT: FACTORS
`LIMIT SUBTHRESHOLD
`LASER
`Why laser treatment currently not an
`important therapeutic modality
`
`Refractive
`32 HOW WFG ABLATIONS
`COMPARE
`No clear patient preference for wavefront(cid:173)
`guided excimer laseiS for myopic LASIK
`
`Practice Management
`37 TAKING ONE FOR THE TEAM
`When putting otheiS before self
`for the good of the group can have
`meaningful outcomes
`
`Special Repmt
`
`SA NON-INVASIVE LOOK AT
`TRABECULAR MESHWORK
`How novel Ocr platform detects motion,
`may advance glaucoma research
`
`11 CONTROLUNG CIRCADIAN
`lOP FLUCTUATION
`Neurons may offer novel glaucoma
`therapeutic target, animal study shows
`
`19 WHEN FIXED-COMBINATION
`IS VIABLE OPTION
`Brinzolamide-brimonidine may benefit
`patients v.tlo have contra indications
`to beta-blocker
`
`In Every Issue
`
`4 EDITORIAL
`
`6 OPHTHALMIC NEWS
`
`34 MARKETPLACE
`
`PAGE 3 OF 40
`
`

`
`4
`
`e d ito ria I
`
`SEPTEMBER 1, 2013 .. Ophthalmology Times
`
`Ophthalmology Times
`
`SEPTEMBER 1, 2013 • VOL 38, NO. 17
`
`The elements of success
`
`By Peter J. McDonnell, MD
`director of the Wilmer Eye Institute,
`Johns Hopkins University School of
`Medicine, Baltimore, and chief medical
`editor of Ophthalmology Times.
`
`He can be reached at 727 Maumenee Building
`600 N. Wolfe St. Baltimore, MD 21287 9278
`Phone: 443/287 1511 Fax: 443/287 1514
`E mail: pmcdonn1@jhmi.edu
`
`Technology may be important, but employees are the real key
`hospital. He has a formal orientation program
`to train employees as they join, and continuing
`education for everyone. Every employee is to
`have a career plan within the organization.
`The educational programs are intended not
`simply to enhance the skill level of employees,
`but also to help them feel that they are engag
`ing in personal development.
`"Our goal is not to get them to perform a lit
`tie better, but to encourage critical thinking
`and problem solving," he said.
`Educational programs must have excellent
`trainers, mix employees from different areas of
`the hospital, be Jess than 2 hou rs in length, and
`be formally assessed and improved with time.
`Trainers are required to make sure their ses
`sions are informative, interesting, and partici
`patory. Teamwork is emphasized.
`Mauro regula rly measures employee satisfac
`tion to determine the effectiveness of various
`employee development and retention initiatives.
`In h is research of the literature, he finds that
`an overall satisfaction score of 45% is consid
`ered quite high, and his hospital has exceeded
`this with a score of 65%.
`Also, he has found that employee satisfaction
`scores are correlated with age. Employees aged
`fewer than 30 years consistently report lower
`satisfaction scores than do older workers.
`In the largest cou ntry of South America, as
`in the largest of North America, there is the be
`lief that younger people and younger physi
`cians have a different approach to work and
`work life balance. People in Mauro's position
`must recognize and respond to that reality.
`
`'7 am not led. I lead."
`- Motto of the city of sao Paulo, Brazil
`
`THE COUNTRY OF BRAZIL has
`changed dramatically in the past two decades.
`After emerging from a military government,
`successive democratically elected governments
`have overseen dramatic economic growth Bra
`zil is 5th or 6th in terms of gross domestic prod
`uct with an unemployment rate lower than
`the United States, plus the emergence of an ex
`tremely large middle class. With this success
`comes greater demand for health care services.
`My friend, Mauro, is an ophthalmologist in the
`largest city (by population) in the Western Hemi
`sphere. In 2010, he opened the first large eye hos
`pita! in this city of 16 million plus people. By all
`measures, this hospital has been a great success.
`From 2010 to 2012, surgeries increased by
`68%, emergency referrals by 600%, routine
`exams by 376%, and ophthalmologists using
`the hospital grew from 13 in 2010 to 198 in
`2012. Any eye hospital in the United States
`would be delighted with such numbers.
`Among Mauro's elements of success:
`!II Assembly line efficiency
`!II Strict quality norms
`!II Brand recognition
`!II Standardization
`!II Consistency
`!II Ruthless cost control
`!II Economies of scale that accompany high volume
`"What is the key element that explains your
`success?" I asked my friend.
`"Having the best technology is important," he
`said, "but the real key is having the best people."
`
`INVESTING IN EMPLOYEES
`Mauro has devoted a lot of attention to attract
`ing and retaining the best employees for his
`
`PAGE 4 OF 40
`
`LESSONS TO LEARN
`What can we ophthalmologists in the wealthiest
`country in the Western Hemisphere Jearn from
`the success of ophthalmic institutions in other
`countries with different cultures, histories, and
`degrees of wealth? A great deal, I believe.
`As downward pressure on health care reim
`bursement continues in the United States, the
`institutions that survive and thrive will be the
`ones that adopt many of Mauro's strategies. •
`
`CONTENT
`Clllef Moll.,. I Elltor Pole<l McOoM.I, MO
`m<*lgos_ans..,....,. 440/891-2703
`Group Content Dbector Matlt L Olugoss
`Content Chi- Dlroclor !J>eryiSt(cid:173)
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`otgltal & lnteracti'HI Coateat M•ac• BtandOI'IGienn
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`Art IMrector NCOI&Da'ds-SIOCu'n
`Anterior Se-eat TKhnlques Er'r'le$tW. t<otrwnehl, MD
`Cataract Corner RiChardS. ttoffman, MOand MatltPadtec, MD
`
`Money Molt ers JCIMJ. Grande, hudyf. Grand' and
`JoMS.Grande,CFPs 0
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`P•reUnal Vlw AUenC. tto, t.t>
`ptastJca Pea.ts RiehardAndet'SOI\ MD
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`codlo&.doc L - -an, MO, MBA
`O.,hthllrolc HerltiCO Notman B.-· MO
`TKh Talk H. Jay Wis-. MO
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`Uwoltls Up dale Emmeu t CUri!gharn ..... MO,I'I10, Ml'li
`Whot's New ot theAAO .IOMGalagher
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`PU BL/S HING f ,iDI'ERTI SING
`Erecutlve VIce President GeotgiaM DeeonlO
`gdeeellOtod_....,. 440/891-2778
`VP, Groop Publisher KenS)Ma
`~«)~-.. -...... 732/348-3017
`Group Publisher L-A>Ia
`~--......... 302/239-56115
`Assodote Prrbl~her EmS<IU'"'
`. . . -... todvanstM.com 215/881>-3804
`National Account Mana&er Rel>eccaA.ItJSSMI
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`Accoont - • • · Classl"ed/
`DlsplayAdvertlslo& o..-Ba~rMG
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`dba_...__ 440/891-2779
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`Account Manacer. Reaultt~eat Ad..,.tillng J:lleeJJe(n&Motan
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`Business Dhetor. eMedla Don Bftman
`- . . -............ 212,/951~745
`Dbector, Sales Data Gal Kaye
`Sales Support H.atw\8h C'A.rls
`Reprints 877-652-5295 00<t. 121 I bl<ol> .. rlgt<snecii.C(Irn
`ruslde IS, UK, dl-ectclal: 281-419-5725. Eld. 121
`Ust Account Eucu•..,. RenH Schustet
`rs<hlSt .... dvanS..._O>m 440/891-2613
`Pert~ls~oas/l nterna.oaal Ucea .. ng Matnen Cannon
`m.......,.-• ....,..._com 440/891-2742
`
`PRODUCTION
`Sea lor PrCMiuctJon MMICtr Karen Ltwuen
`
`,tUDIENCE DEI'ELOPMENT
`Corporate Dbector J1:Jt Putto
`Director ClwlstlneS._a
`Manacer WendyBq
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`fADVANSTAR
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`Clllef Erec utlve Of"cer: Joeloegla
`C.lef EMCutJ..,. Offtcer FasNon Group.
`EucutJ..,. Vlce·Presldent: Tom Aor1o
`EucutJ..,. Vlce·Presldent, CNef Adr~J..-,_._...,. Otncer &
`C.lef Financial Otncer: Tom Ehardt
`Erecutlve VIce-President GeorglaM DeC..,.
`EucutJ..,. Vlce·Presldent: Ctwl:s DeoM~
`EucutJ..,. Vlce·Presldent: RonWtA
`EucutJ..,. Vlce·Presldent, Business Syst ... s: RebeCCa £\<~ou
`SrYice·Presldent: hey Harris
`VIce-President, -Ia O.,erotl...,: R'ards(cid:173)
`VIce-President, tecal: Mlchaellle<nsteln
`Vlce·Presldent, Bec.-oalc lnfortMt.lon T~nology:J. VaugM
`
`~YINtlr C....,..ilfcetlons Inc. p~ C!rUin CUSIOI'Mt COIUCt diU (klctl as
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`v.t10 ~ to pi)I'I'ICI(e Jl!levltt p-oclueU, ta'ltoes., and Ollet opportlrili!s tNl ..,
`beofbeii!!SttO)'OU l~dOnotwartAd .... !UfCOft'll't'U'IbiOnStle tONieyfU
`COIUCt l'lblnedonalll!litebteto titdperles tormllbl.tCJUP09eS. Mlrtfcal kllfee
`866 529 2922 b!lweet1 fie hOLliS of 7 SO am ancl5p m CST and a c:usaomet9ePice
`tel)le9etl18t..e'llilaset)'OUinte~JfUIWI'IetlomAd,...hf"SISU Outslclefle
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`Of*Ulaaoloty 11- does notv~y&"feleiiriSOf<llhet ll'llcmeleln IWNiiii'C l'l llrf
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`Of*Ulaaoloty """'" iS • ftlt'lbet of fie A8SOC:IIlbn « tlcl$enclert cane~~
`Publlealonstle
`Ubnltf Ace• s Lber'i! sd1i!tota'le aecess to a.nentancl beck awes « Othhlllmdotf
`Ones hOUflthe EBSCOhOstdi!Ubeses
`To s .mert•. ealt01fee888 5271008 OtastlefleUS eal 218 740 6477
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`~merican
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`~~ ~~ AMMI=
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`u!':A'.
`
`

`
`SEPTEMBER1.2013 •• Ophthalmology Times
`
`ed ito ria I a dvi so r board
`
`5
`
`Ophthalmology Times EDITORIAL ADVISORY BOARD
`Chief Medical Editor
`Peter J. McDonnell, MD
`wtner E)e hstitute
`Jctns lqms tn.l!fmy
`Baltina"e. t.()
`
`Anne L. Col eman, MD
`.lllesSieh Eye~stillle,UO.A
`loSAfllele~CA
`Ernest w. Kornmehl, MD
`Halml & TulsUrr....i!ies
`8oS10n,MA
`
`Associate Medical Editors
`Dl mltr I Azar, MD
`Ulw.mtydlln:lis,Cit:ago
`Olblgo,L
`
`Robert K. Maloney, MD
`loSAfllele~CA
`
`Joan Miller, MD
`MamlluseHsfye &Ear~lnno'y
`Halml Uliv<nity
`8oS10n,MA
`
`Randall Olson, MD
`Ulwernitydt~m
`Sll!llt.eCiy,UT
`
`Robert Osher, MD
`Ulwernl!ydClnam~
`anam~Oti
`
`Peters. Hersh, MD
`Urr.ntyoiMedi:irle & Oellistyd New Jerset
`N ... Jt,NJ
`Jonathan H. Talamo, MD
`HarvaroUrr..rnity
`Bostoo,MA
`Kazuo Tsooola, MD
`KsioUrr.ntySdlodoiMedone
`Tokyo,J..,..,
`
`Anterior Segment/Catamct
`Comea/l'xtemal Visease
`Ashl ey Behrens, MD
`\\bar Eye ~sil!fe, .tlhlsHqJIOnsUlw.mty
`Ballrooe,MD
`Rooens Belfort Jr., MD
`FedErliiUrr..JSiyol Silo Pallo
`SiloPaJio,lnzl
`Elizabeth A. Davis, MD
`Uliv<nityd Mn"'Sda,
`Mn"'~l.tl
`Uday Devga n, MD
`.lllesSieh Eye~stillle,UO.A
`loSAfllele~CA
`Richards. Hoffman, MD
`Oregoo He.m. &Science Ulwernity
`l'o'tfld,Ofl
`Samuel Masket, MD
`.lllesSieh Eye~stillle,UO.A
`loSAfllele~CA
`Bartly J. Mondlno, MD
`.lllesSieh Eye~stillle,UO.A
`loSAfllele~CA
`Mark Packer, MD
`Oregoo He.m. &Science Ulwernity
`l'o'tfld,Ofl
`Michael Ralm~an, MD
`MamllusensEye & fa~ Harm! Ulw.mty
`8oS10n,MA
`Michael Snyder, MD
`Clnam~Eye~stillle
`Cln<im~Oti
`Walter J. Slark, MD
`\\bar Eye ~sil!fe, .tlhlsHqJIOnsUlw.mty
`Ballrooe,MD
`Farrell "Toby" tyson, MD
`CapeCcra!Fl
`Glaucoma
`Robert D. Fechtner, MD
`Ulw.mtyd Me<kine& OErlislyol New JeiSef
`N ... Jt,IU
`Neeru Gupla, MD
`Ulw.mtydTomn~
`Ttrofllo, Cooada
`Mallk Kahook, MD
`Ulw.mtyd Cdcrado)JErlver
`o ... ..,~oo
`Richard K. Parrish II, MD
`BasmmPamer Eye lesii!J!e, Ulimi!yd llirfri
`llirfri,Fl
`Harry A. Quigley, MD
`\\bar Eye ~sii!J!e, .tlhlsHqJIOnsUlimi!y
`Ballrooe,MD
`
`Robert Ritch, MD
`New VOII<Eye& Ew ~fnnary
`New \'Oil<, NY
`Joel Schuman, MD
`V....rni!t ol Pllslltrgh Medllll Cen!EI'
`Pilslltrgh,PA
`Kuldev Singh, MD
`Slall<rdUliv<nity
`Slall<rd,CA
`Robert N. WeiiVeb, MD
`-ooGwarnaCErller
`urr..mttoiCaUomia, San Diego
`
`Neuro-Oplltllalmology
`Andrew G. l ee, MD
`MeUl:l<istHOSIJill. TeJllSMedbliCen!EI'
`Ho!Sioo, TX
`Oculoplastics/
`Reconstructil'e Surgery
`Robert Goldberg, MD
`J<issSiein flO ~sii!J!e, UCLA
`losAAgeles, CA
`John T. LI Yecchl, MD
`St llt.e~C<~n:t &l a<EI' ~silule
`T'"ll"lSc>'rli~R
`Shamath L. Merbs, MD
`1\imo'EyelestiiJte,.tllnsHopiOnsUlirerni!t
`Mme,MD
`
`Retina/Vitreous
`Sian ley Chang, MD
`CdUII'(iaUlw.mty
`New\'ai<,NY
`David Chow, MD
`Urr.ntyoiTORrl~
`ToRrl~.Cooada
`Pravln U. Dugel, MD
`Pllcelix,AZ
`Sharon Fekrat, MD
`Oll<eUrr..rnity
`Olllla'n,NC
`Julia Hailer, MD
`Wilsfyeles1i!J!e, Th:lma<Jell""'nUrr..rnity
`PllladEflllia,PA
`Tarek s. Hassan, MD
`Od<mdurr..mtt
`RodleSIEI',MI
`Mlchael lp, MD
`Urr..rnityoiW'ISalnsin
`l'ediatric Oplltllalmology
`Ma<ison, WI
`Carmen A. Pullaflto, MD
`Norman B. Medow, MD
`MlertEhstein Co legeoiMedone
`Ksd<Sdlodol Medone, USC
`lOSAfllele~ CA
`&mx,NY
`Carl D. Reglllo, MD
`Jemlfer Simpson, MD
`Wilsfyeles1i!J!e, Th:lma<Jell""'nUrr..rnity
`urr..mttoiCaUomia,hine
`tt..,, CA
`PllladEflllia, PA
`LawrenceJ. Singerman, MD
`H. JayWisnlckl, MD
`NewVOII<Eye&Ew~lnnary, Be~ ... aMeoc~ Case WeS1em ReseM!Urr..rnity
`c-oo Oil
`Cen!EI', AbertfllS1e nCdlege d Me<kine
`NewVOJt,NY
`'
`lfl•eitis
`Emmett T. Cum Ingham Jr., MD, PhD
`Stoot<r<tUlwernity
`Slool<rd,CA
`
`l'mctice Alanagement
`Joseph c. Norelka, MD
`Medlla,Oti
`Frank welnstock, MD
`BocaRa!oo,Fl
`
`ClliefMedicall'.ditors(cid:173)
`f.meritus
`Rejracti1•e Surgery
`Jack M. Dodlck, MD
`NewYai<UlwernitySdloold Me<kine
`William Culbertson, MD
`BasccrnP-Eyelnstillle, U....rnilfol llirfri New Yai<,NY (1976-1996)
`Ma'l'i, R
`David R. Guyer, MD
`New Yai<,NY (1996-2004)
`Kenneth A. Greenberg, MD
`OoollJyHosptj
`Ooolll'f,CT
`New Yal< Ul"'rnilf
`New \'Oil<, NY
`
`Ophthalmolog) lunes Industry Council
`Marc Gleeson
`MErgoo~c.
`VIle l'lesiiErll U.S. Eye Carel'llamaoeuli:als
`Gb"'""" ood Extemal Osea<el.!alt.elllg
`Mark Newkirk
`Rei:h!rt T«<lndU!jes
`Oi'etl«o1Gkll8 Ma11<elngood$aes
`Ram Palankl
`llrofl'lloGErli:S~C.
`Gb~Head- Mafl<elilgoods.tes
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`John Bee
`Rlein Meek:~ ~c.
`l'lesiiErlloodCIO
`William Bum ham, OD
`Cal Zeiss Medllec ~c.
`0illCI!l'Otl.!al1<e!Oe""""""lAmEI'bls
`Alaslalr Douglas
`Atoo llllaa~li!s~c.
`Oil!CI« ol US. Coornerd!j SullllOrt
`Bob Gibson
`TOflCOO Medbll Systems In::.
`Vllel'lesiiErlldMafl<eiJii
`
`Dalna Schmidt
`Bausdl + lombSullle~
`Qobll E"""'!.ire Oi'etl« oiPro<lltl Slralegy
`Kelly Smoyer
`EsslordAAleli:a
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`• Being a faun frlo!11thalllllklgsts to oonm111k:ate their cirical m!YMedge, ilsights, aoo dseov«ies.
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`

`
`6
`
`0 htha I m ic news
`
`SEPTEMBER1, 2013·· OphthalmologyTimes
`
`( In Brief )
`
`In memoriam
`GLAUCOMA RESEARCHER
`DR. BERNARD BECKER DIES
`ST. LOUIS:: BERNARD BECKER, MD, chairman
`of the ophthalmology department at the Wash
`ington University School of Medicine in St. Louis
`for 35 years, has died.
`Dr. Becker, 93, passed away Aug. 28 at his
`home in St. Louis after a battle
`with lung canoer.
`Dr. Becker was known for dis
`CCNering one d the first treatments
`for glaucoma a drug called aoet
`azolamide used to decrease pres
`sure in the brain. He determined
`the drug could also be used to
`decrease pressure in the eyes.
`From 1953 to 1988, Dr. Becker helped Wash
`ington University build its Department of Ophthal
`mology and Visual Arts. He was also one of the
`founders of the Association for Research in Vision
`and Ophthalmology, and helped establish the Na
`tional Eye Institute.
`In 1995, Washington University renamed its
`medical library in his honor.
`Dr. Becker grew up in Brooklyn, NY, and gradu
`ated from Prinoeton University and Harvard Medi
`cal School. He was also an army psychiatrist dur
`ing World War II.
`Following the war, Dr. Becker trained in ophthal
`mology at Johns Hopkins University.
`Dr. Becker has received many awards, including
`the American Academy of Ophthalmology's high
`est honor. He has also co written the first two edi
`tions of "Diagnosis and Therapy of the Glaucomas."
`
`Washington University is planning a memorial
`servioe for Dr. Becker, who donated his body to
`the university's school of medicine.
`
`Ajli!Jercepl indication
`REGENERON INJECTION GAINS
`EUROPEAN APPROVAL
`TARRYTOWN, NY:: REGENERON PHARMACEUTI(cid:173)
`CALS' new treatment for visual impairment due
`to macular edema secondary to central retinal
`vein occlusion (CRVO) has been approved by the
`European Commission.
`Afliberoept (Eylea) was approved in the United
`States for the treatment of neovascular (wet) age
`related macular degeneration (AMD) in 2011, and
`for macular edema following CRVO in 2012.
`· we are pleased with the approval of (afliber
`cept) in the European Union in a second indication,"
`said George D. Yancopoulos, MD, PhD, chief scien
`tific officer of Regeneron and president of Regen
`eron Laboratories. · our phase Ill studies showed
`that (aflibercept) improved visual outcomes signifi
`cantly .... This additional approval of (aflibercept)
`is great news for patients in Europe."
`Afliberoept has also been approved in Europe,
`Japan, Australia, and in several other countries
`for use in wet AMD and in selected countries in
`South American for macular edema following CRVO.
`
`I
`
`ClARIFICATION The first installment of the new
`"Gloves Off with Gulani" series will begin in the
`Oct. 1 issue of Ophthalmology Times. Missed the
`series introduction? Go to http:jjbit.lyj15memRo.
`
`HEADLINES YOU
`MIGHT HAVE MISSED
`
`AS SEEN IN Ophthalmology Times' weekly
`eReport Sign up at http:ffwww.modemmedicine.
`comjOphthalmologyTimesjenewssignup
`
`CMS CLEARS RETINAL
`PROSTHESIS SYSTEM
`SECOND SIGHr MEDICAL PRODUCTS' retinal
`prosthesis system has been approved by the
`Centers for Medicare and Medicaid Services
`for both inpatient and outpatient settings of
`care payments beginning Oct. 1 .
`http://blt .lyj14gaM8H
`
`INSITE VISION EARNS
`PATENT ISSUANCE
`INSITE VISION INC.'S DRUG DELIVERY SYS·
`TEM has received a patent from the U.S. Patent
`and Trademark Office. The patent will provide
`utility composition of matter protection until
`2029 for JnSite Vision's DuraSite 2 for both its
`delivery system and drugs.
`http://blt.lyj1 anYtLa
`
`VMA TREATMENT
`OK'D IN CANADA
`HEALTH CANADA HAS CLEARED Thrombo
`Genies NV's treatment for symptomatic vitreo
`macular adhesion. Canada is now the first mar
`ket where ocriplasmin (Jetrea) is approved out
`side the United States and Europe.
`http://blt .ly/121U5r8
`
`On Twitter
`Recent hashtags Ophthalmology Times
`has used on twltter.com/OphthTimes
`
`#ophthalmology
`#eyecare
`
`#astigmatism
`
`#retina
`
`#AM D
`#myopia
`
`#eye health
`
`#cataract
`#dryeye
`
`#dispensing
`
`#optical
`#AMD
`
`PAGE 6 OF 40
`
`Introducing the
`Ophthalmology Times
`app for iPad and
`iPhone. Download
`it for free today at
`Ophthalmology Times.
`comjOTapp.
`
`Video
`See how an
`iPhone can be
`used in place of
`a traditional slit
`lamp camera.
`Go to http:jjbit.
`lyj15mzBCL
`
`

`
`RYBAcK.e'e
`
`It's time for a change.
`
`‘Discover’ LumIe_na_l Cqntrpl. The _EX~PRESS' Glaucoma Fiftratian
`Device aiinfinates jone of the most critical su rgical variables.
`
`By standardizing the lurnenal‘ structure through which aq ueuus
`humor filuw-5, W”-_g.2t consistent, predictabie filtration.
`
`AIc.on'
`aNova,ti5compa,-,y
`
`O20-iiflurarfis TF1} EH’l3042!.M]} M.y.|\1I:m1.uJm
`
`EXPRESS
`Glaucoma Filtration Device
`
`C.Illl1IIl:FederaIla1_u remfns mhderkemsaiehymm memderdapbysidan.
`llflcfiflfll: me EIPRESS'fila ummafltraflannevnis htmded to reduceinmunlarpuesstnrein glauzuma pa1ientswd1e1e rned.k:a1a‘ni uzwersfiunal stigkal treairnentshave faihd.
`GIIIJIIICHIEGIIIIHS :l'l_|ES£LE(1l0lI IIF HIE hPPlil‘Illl'E'E||S|BH: Pr|urcin+m1stndia we-e nutdeiigned mcompae betweenthe lra-flous versions nfthefli PRESS‘ Glaumma Eltradnn Device.
`Iltesdectfion afefieappmpfiate versim is acming ta theuiomrs dim-euim.
`l.'lMlTII.IIIIIII:It11llllS:I11eLL9e at-this device Is cmcrahmdkated if u'se'urmm'e ofthe fa Hum; umcflrtium eaelst:
`-Paesencu of ocuiardisease such asmeiiis, ucuar 'l1fed‘iMI,,se1rered.ry eye, seven blephariiis
`-Pre enisfmg amlar urs;rSl.‘fln‘I( pathdagythz, in the ups‘ nicm ufthesurgeonjs I hdym cause puatqneraiive cnmpications hihvisg Inpla madam nfthe device.
`-flattens diagnnsgad with angled-csure glauuma.
`|l'.I.|lll|lI3S.'PIIE(.I1lTllllS:
`-The surgeon shtnuldhe iamiar north the immmhrrs {muse
`-the iniegrtyuftre padcage should be enmi nedpmxmuseardihedevkesluuii I10-lhe'I.|5e1:| fthepadrage 1-sdarrnagedandsenlityis cnmpramised.
`-This device isforshgteuseunl-y.
`-MRI afthehead ispennLt1ed,huwever nota-ecommen|{ed,'|nt‘1'se fnsttwuweeius pustinfla mama.
`I1'l'Bll'lfll: ifieferencetim Dh‘e4:t«hJns.far»l|se1:dJeing fora carrqalet fsthg uflndicathm, In-amhgs, 31Iac.°M.I1:I1:., mmpiluflms and adverse evems.
`
`PAGE70F40
`PAGE 7 OF 40
`
`

`
`ADVANCES CONTINUE TO PROGRESS FOR THE TREATMENT AND MANAGEMENT OF GLAUCOMA
`
`TM Movement Necessary to Account for Aqueous Outflow?
`
`2 pljmin + 60 bpm = 0.03 pi/sec
`
`t
`
`t
`
`t
`A NON-INVASIVE LOOK
`AT TRABECULAR
`MESHWORK
`How novel OCT platform detects and measures motion,
`may advance glaucoma research and patient care
`By Cheryl Guttman Krader; Reviewed by Murray Johnstone, MD
`
`SEATTLE ::
`
`P hase sensitive optical coherence tomog
`
`raphy (PhS OCT) for in vivo evalua
`tion is a promising tool for advancing
`glaucoma research and patient care,
`according to findings from a human study presented
`by Murray Johnstone, MD.
`The investigational device developed by Ruikang Wang, PhD,
`professor of bioengineering, University of Washington, Seattle
`has resolution at the nanometer scale and moves OCT technology,
`which is limited to structural imaging, to a new realm involving
`characterization of motion and function.
`PhS OCT was h ighly sensitive for detecting trabecular mesh
`work motion, according to results of an initial laboratory study
`involving enucleated primate eyes. The study also showed the tis
`
`take-home
`
`• An investigational
`non-invasive imaging
`tool- phase-sensitive
`optical coherence
`tomography- can be
`used to detect and
`measure movement
`of the trabecular
`meshwork in ~vo.
`
`PAGE 8 OF 40
`
`(FIGURE 1) Aqueous outflow from Schlemm's
`canal (SC) is pulsatile, being dependent
`on trabecular meshwork (TM) motion with
`optical coherence tomography measurements
`indicating the TM motion is adequate to
`account for all of aqueous outflow. (A Pis
`anterior posterior SC length. (Figure rourtesy
`of Murray JohnsfDne, MD)
`
`sue movement correlated to a simulated car
`diac pulse with amplitude trabecular motion
`sufficient to accou nt for aqueous outflow.
`
`EXAM/XING TilE IJUMAX STUDl'
`A second study using PhS OCT was then con
`ducted in 10 human adults to investigate pulse
`induced trabecular meshwork motion, said Dr.
`Johnstone, clinical professor of ophthalmology,
`University of Washington.
`As in the animal stu dy,
`PhS OCT was h ighly sensi
`tive for detecting trabecular
`meshwork motion.
`Analyses of the trabecu
`Jar meshwork tissue motion
`wave, in relation to the digi
`tal pulsimetry wave, showed
`a high correlation between
`trabecular meshwork wave minima and digital
`pulse peaks. The research also showed PhS
`OCT could be used to measure velocity of the
`trabecular meshwork motion and the strain rate.
`"This technology opens a new window into
`understanding abnormalities of trabecular mesh
`work biomechanics leading to glaucoma," Dr.
`Johnstone said. "It will eventually revolution
`ize our approaches to glaucoma management."
`
`Interest in developing technology for evaluat
`ing trabecular meshwork motion derives from
`revised concepts about aqueous outflow and
`resistance.
`Whereas in itial work by Morton Grant, MD,
`posited that the trabecular meshwork acted as
`a rigid, restrictive filter creating resistance,
`addit ional research demonstrated that the
`tissue was highly compliant. This indicated
`that movement of the trabecular meshwork
`becomes appositional with the external wall
`of Schlemm's canal and represented the most
`important source of resistance.
`Findings from h istological studies provided
`support for this concept, but direct evidence of
`trabecular meshwork motion in vivo was Jack
`ing until the development of PhS OCT.
`Q/ntinues on page 15 : Non Invasive
`
`

`
`For patients starting or changing PGA therapy
`
`PAGE9 OF40
`
`

`
`LUMIGAN® 0.01% AND 0.03%
`(bimatoprost ophthalmic solution)
`
`Brief Summary—Please see the LUMIGAN® 0.01% and 0.03% package
`insert for full Prescribing Information.
`INDICATIONS AND USAGE
`LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the
`reduction of elevated intraocular pressure in patients with open angle glaucoma or
`ocular hypertension.
`
`CONTRAINDICATIONS
`None
`
`WARNINGS AND PRECAUTIONS
`Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes
`to pigmented tissues. The most frequently reported changes have been increased
`pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is
`expected to increase as long as bimatoprost is administered. The pigmentation
`change is due to increased melanin content in the melanocytes rather than to
`an increase in the number of melanocytes. After discontinuation of bimatoprost,
`pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital
`tissue and eyelash changes have been reported to be reversible in some patients.
`Patients who receive treatment should be informed of the possibility of increased
`pigmentation. The long term effects of increased pigmentation are not known.
`Iris color change may not be noticeable for several months to years. Typically, the
`brown pigmentation around the pupil spreads concentrically towards the periphery
`of the iris and the entire iris or parts of the iris become more brownish. Neither nevi
`nor freckles of the iris appear to be affected by treatment. While treatment with
`LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) can be continued in
`patients who develop noticeably increased iris pigmentation, these patients should
`be examined regularly.
`Eyelash Changes: LUMIGAN® 0.01% and 0.03% may gradually change eyelashes
`and vellus hair in the treated eye. These changes include increased length, thickness,
`and number of lashes. Eyelash changes are usually reversible upon discontinuation
`of treatment.
`Intraocular Inflammation: LUMIGAN® 0.01% and 0.03% should be used with
`caution in patients with active intraocular inflammation (e.g., uveitis) because the
`inflammation may be exacerbated.
`Macular Edema: Macular edema, including cystoid macular edema, has been
`reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01%
`and 0.03% should be used with caution in aphakic patients, in pseudophakic
`patients with a torn posterior lens capsule, or in patients with known risk factors for
`macular edema.
`Angle-closure, Inflammatory, or Neovascular Glaucoma: LUMIGAN® 0.01% and
`0.03% has not been evaluated for the treatment of angle closure, inflammatory or
`neovascular glaucoma.
`Bacterial Keratitis: There have been reports of bacterial keratitis associated with
`the use of multiple dose containers of topical ophthalmic products. These containers
`had been inadvertently contaminated by patients who, in most cases, had a
`concurrent corneal disease or a disruption of the ocular epithelial surface.
`Use With Contact Lenses: Contact lenses should be removed prior to instillation
`of LUMIGAN® 0.01% and 0.03% and may be reinserted 15 minutes following
`its administration.
`
`ADVERSE REACTIONS
`Clinical Studies Experience: Because clinical studies are conducted under widely
`varying conditions, adverse reaction rates observed in the clinical studies of a drug
`cannot be directly compared to rates in the clinical studies of another drug and may
`not reflect the rates observed in practice.
`In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%) the
`most common adverse reaction was conjunctival hyperemia (range 25% 45%).
`Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival
`hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common
`reactions (>10%) included growth of eyelashes, and ocular pruritus.
`Additional ocular adverse reactions (reported in 1 to 10% of patients) with
`bimatoprost ophthalmic solutions included ocular dryness, visual disturbance,
`ocular burning, foreign body sensation, eye pain, pigmentation of the periocular
`skin, blepharitis, cataract, superficial punctate keratitis, periorbital erythema,
`ocular irritation, eyelash darkening, eye discharge, tearing, photophobia, allergic
`conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema,
`conjunctival hemorrhage, and abnormal hair growth. Intraocular inflammation,
`reported as iritis, was reported in less than 1% of patients.
`Systemic adverse reactions reported in approximately 10% of patients with
`bimatoprost ophthalmic solutions were infections (primarily colds and upper
`respiratory tract infections). Other systemic adverse reactions (reported in 1 to