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Virginia Eye Consultants Tertiary Referral Eye Care Since 1963
• John D. Sheppard, MD, MMSc • Walter O. Whitley, OD, MBA, FAAO Innovations in Glaucoma • Stephen V. Scoper, MD • Mark Enochs, OD • David Salib, MD • Cecelia Koetting, OD, FAAO COPE#52116-GL • Elizabeth Yeu, MD • Christopher Kuc, OD • Thomas J. Joly, MD, PhD • Leanna Olennikov, OD • Dayna M. Lago, MD • Jillian Janes, OD • Constance Okeke, MD, MSCE Walter O. Whitley, OD, MBA, FAAO • Esther Chang, MD Director of Optometric Services • Jay Starling, MD Virginia Eye Consultants • Samantha Dewundara, MD Residency Program Supervisor • Surajit Saha, MD Pennsylvania College of Optometry
Disclosures Walter O. Whitley, OD, MBA, FAAO has received consulting fees, honorarium or research funding from: • Alcon • Diopsys • Allergan • Ocusoft • Bausch and Lomb • Science Based Health • Biotissue • Shire • Beaver-Visitec • TearLab Corporation
• Publications – Advanced Ocular Care – Co-Chief Medical Editor – Review of Optometry – Contributing Editor – Optometry Times – Editorial Advisory Board
The Most Valuable Glaucoma Tool Glaucoma: Diagnosis
• We know it when we see it
IOP: 26 OU
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Glaucoma Diagnosis Glaucoma Diagnosis
• Central corneal thickness
• Visual fields
• Scanning lasers
• Serial tonometry
• Electrodiagnositics – VEP / PERG
GLAUCOMA SEVERITY SCALE Managing Glaucoma Patients DEFINITIONS • Mild Stage: optic nerve changes consistent with glaucoma but • Monitor IOP reduction: 1-2 week, 1 month NO visual field abnormalities on any visual field test OR abnormalities present only on short-wavelength automated • Check IOP every 3-4 months
perimetry or frequency doubling perimetry. • Repeat VF every 6-12 months
• Moderate Stage: optic nerve changes consistent with • Disc photos every 1-2 years glaucoma AND glaucomatous visual field abnormalities in one hemifield and not within 5 degrees of fixation. • Gonioscopy every year
• Optic nerve analysis every 6-12 months • Severe Stage: optic nerve changes consistent with glaucoma AND glaucomatous visual field abnormalities in both • Document everything hemifields and/or loss within 5 degrees of fixation in at least one hemifield. http://www.aoa.org/optometrists/tools-and-resources/clinical-care-publications/clinical-practice-guidelines?sso=y http://www.americanglaucomasociety.net/professionals/glaucoma_staging_codes_teaching_module/ https://www.aao.org/guidelines-browse?filter=preferredpracticepatterns
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Corneal Hysteresis How ORA Works
1st IOP
1st IOP 1st IOP
Air-jet stops Air-jet stops
2nd IOP
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ORA—Signal Plot
“In” signal peak “Out” signal peak Start Thinking Weak vs. Strong IOP 1 IOP 2
Wells AP, Garway-Heath DF, et a. Corneal hysteresis but not corneal thickness Correlates with optic nerve surface compliance in Relationship of IOP and Glaucoma patients. Invest Ophthalmol Vis Sci 2008 Corneal Hysteresis
Corneal IOP Hysteresis
Lower CH = More Likely to Respond to Topical Medications
Higher CH = Less Likely to Respond to Topical Medication
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Anand A, De Moraes CG, Teng CC, et al. Corneal hysteresis and visual field asymmetry in open angle glaucoma. Invest Ophthalmol Vis Sci 2010;51:6514
More Likely to Respond to Topical Medications Association with Progressive Low CH Field Worsening
Greater Structural Bowing of Congdon NG, Broman AT, Bandeen-Roche K, Lamina Cribrosa et al. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol 2006;141:868
Structure Function Structure Function Fundus Photograph Visual Field Optical Coherence Tomography ERG (Subjective) (Subjective) (Objective) (Objective)
When Do I Use Electrophysiological Tests? Electrophysiology objectively measures strength and speed of the visual signal to the • Clarify Differential Diagnosis…. Is it Systemic or brain (VEP) or retina (PERG) Trauma vs. Ocular?
• When Standard Tests are Unattainable or Unreliable VEP (neuro)
• When Other Tests are Inconsistent or Borderline Result PERG (retinal) • To Monitor Subclinical Disease for Functional Changes and Alter Treatment and Efficacy
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ELECTROPHYSIOLOGY DETECTS CHANGES EARLIER THAN OCT AND VISUAL FIELD1 Visual Evoked Potential (VEP)
• Main Indications – Glaucoma Asymptomatic Symptomatic OCT – Multiple Sclerosis Healthy OHT Glaucoma PERG/VEP VF – Ischemic Optic Neuropathy Non structural Documented – Traumatic Brain Injury structural damage damage documented – Amblopyia – Other Neuropathies
1. Parisi V, Miglior S, Manni G, Centofanti M, Bucci MG. Clinical ability of pattern-electroretinograms and visual evoked potentials in detecting visual dysfunction in ocular hypertension and glaucoma. Ophthalmology. 2006 Feb;113(2):216-28.
WHY USE VEP? Pattern ERG = PERG • VEP is an objective, functional test when standard tests cannot provide sufficient Main Indications information for diagnosis and treatment. • Many optic nerve diseases are asymptomatic Glaucoma because central vision is not affected until late Maculopathies in the disease1 • Diagnosis and management of optic nerve disorders are often based on structural or Can also help the clinician differentiate 2 between retinal and optic nerve disorders subjective visual field tests when used in conjunction with Visual Evoked Potential (VEP).
How Does PERG Work?
AAO Basic Science Course 2015/2016: Since the PERG (in contrast to the flash ERG) is a local response PERG is a useful tool for the early diagnosis of glaucoma from the area covered by the retinal stimulus image, specifically GCC, it can be used as a sensitive indicator of dysfunction within the macular region and it reflects the integrity of the optics, photoreceptors, bipolar cells and retinal ganglion cells.
*Source: http://www.iscev.org/standards/pdfs/ISCEV-PERG-Standard-2013.pdf
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Visual Assessment Per NIH and Bascom-Palmer
“In patients who are glaucoma suspects, PERG signal anticipates an equivalent loss of OCT signal by several years (as many as 8 years).”
IOP 26 mmHg IOP 18 mmHg IOP 18 mmHg Treatment initiation Invest Ophthalmol Vis Sci. 2013;54:2346–2352) DOI:10.1167/iovs.12-11026
Ganglion Cell Function Measured By ERG Dynamic Visual Function Assessment After IOP Reduction in POAG • Researchers concluded that significant IOP- lowering therapy could improve RGC function measured by PERG in patients with preperimetric and early stages of POAG – IOP significantly decreased avg 31% – Increase in MOPP avg 14% – PERG amplitude of P50 and N95 waves increased in 75% and 79% eyes
IOP 26 mmHg IOP 18 mmHg Treatment initiation IOP 18 mmHg Karaśkiewicz J, Penkala K, Mularczyk M, et al. Evaluation of retinal ganglion cell function after intraocular pressure reduction measured by pattern electroretinogram in patients with primary open-angle glaucoma. Doc Ophthalmol. 2017; Feb 7. [Epub ahead of print].
Dynamic Visual Function Assessment Glaucoma: Treatment • Goal of treatment – Halt further visual loss – Halt further optic nerve damage
• How We Treat PERG – Reduction of IOP slows progression of glaucoma
• Treatment options – Medications – Laser therapy – Surgical intervention
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Glaucoma: Medications First Line Therapy: Prostaglandins
• All active first line drugs are effective compared with placebo in reducing IOP at 3 mos • Bimatoprost, latanoprost, and travoprost are most efficacious and within-class difference were small
Tianjing Li, Lindsley K, Rouse B, et al. Comparative effectiveness of first-line medicationsfor primary open-angle glaucoma. Ophthalmology. 2016;123(1):129-40.
How Do Patients Feel about their Drop Overall Compliance Rates Usage? • 10% - 25% take none of their prescribed medication • 68 glaucoma pts • 54% stated their drops were expensive • 25% - 35% take all of their medication as prescribed • 72% were suffering from side effects
• 91% said medical therapy represented • Majority are partially compliant minimal/no inconvenience
• 82% were interested in learning about
procedures that could reduce or possible eliminate their need for drops
1. Weintraub M. Compliance in the elderly. Clin Geriatr Med. 1990;6:445-452. 2. Lamy PP. Compliance in long term care. Geriatrika. 1985;1(8):32. 3. Coleman TJ. Non-redemption of prescriptions: linked to poor consultations. BMJ. 1994;308(6921):135.
Patient Compliance and Dosing Continuous Use • Literature review of 76 studies show – Compliance increases
with decreased dosage regimen and complexity1 – 79% compliance with QD
Compliance regimen vs 51% for QID regimens (p=0.001)1 – Simpler, less-frequent dosing results in better Dosing (Times/day) compliance in a variety of Nordstrom, Friedman, et al. Ophthalmology 2005 therapeutic classes1
1. Claxton et al. Clinical Therapeutics. 2001; 23:1296-1310.
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How Adherent are Glaucoma Patients Poor Adherence To Glaucoma Therapy with QD Medication? • By one year after first eye drop Rx, less than 50% are still filling prescription
• Among New Jersey Medicaid seniors, 25% never filled the second prescription
• Average number of treated days = 70
Reardon, Schwartz, Mozaffari. Clin Therap 2003;25:1172 Gurwitz et al. Am J Public Health 1993;83:711-6.
Glaucoma: Medications Glaucoma Surgical Options
• When COMPLIANCE with drops is low • Laser Therapy • When MEDICAL THERAPY FAILS – SLT • When the PROGRESSION continues to WORSEN – ALT – LPI
• Surgical Options • Treatment options – Trabeculectomy – Medications – Trabectome – Laser therapy – Express Shunt – Surgical intervention – Tube shunt – Canaloplasty – ECP
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The ABC(DE)’s of Choosing a Surgery Glaucoma Clinical Trials Ronald L. Fellman, MD, Dallas • Collaborative Normal Tension Glaucoma Study (NTGS) • Advanced Glaucoma Intervention Study (AGIS) • A – Age / Angle • Collaborative Initial Glaucoma Treatment Study (CIGTS) • B – Blood aqueous barrier • Ocular Hypertensive Treatment Study (OHTS) • C – Conjunctiva • Early Manifest Glaucoma Trial (EMGT) • Glaucoma Laser Trial (GLT) • D – Disc / Discussion • E - Expertise
Accessed on September 13, 2012 from http://revophth.com/content/d/glaucoma_management/i/2088/c/36431/
Selective Laser Trabeculoplasty Selective Laser Trabeculoplasty
• Non-thermal treatment which uses short • IOP decrease after SLT pulses of relatively low energy to target and – Primary Therapy - 28.7% irradiate only the melanin-rich cells in the TM – Adjunctive therapy – 19.4% – Replacement Therapy – 4.5%
– Retreatments – 12.1%
http://www.youtube.com/watch?v=cU1aS5_J0gE
SLT Procedure Selective Laser Trabeculoplasty versus Medical Therapy as Initial Treatment of Glaucoma: a Video Courtesy Nate Lighthizer, OD Prospective, Randomized Trial • PURPOSE: To compare outcomes of selective laser trabeculoplasty (SLT) with drug therapy for glaucoma patients in a prospective randomized clinical trial. • RESULTS: 54 patients reaching 9 to 12-months follow-up. – SLT (29 pts) • Baseline IOP 24.5 mm Hg • Mean IOP at follow up 18.2 mm Hg – Med (25 pts) • Baseline IOP 24.7 mm Hg • Mean IOP at follow up 17.7 mm Hg – SLT group -> 11% of eyes required additional SLT – Prostaglandin group -> 27% of eyes required additional medication
Katz, LJ, Steinmann, WC, Kabir, A. et al. J Glaucoma. 2012 Sep;21(7):460-8
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Selective Laser Trabeculoplasty as Initial and Adjunctive Treatment for Open-Angle Glaucoma Cost Considerations • Purpose: To investigate the efficacy and safety of • Cantor LB et al: Economic evaluation of selective laser trabeculoplasty as an initial treatment medication, laser trabeculoplasty and filtering for newly diagnosed open-angle glaucoma, and its role as adjunctive therapy surgeries in treating patients with glaucoma in • SLT the US. Curr Med Res Opin. 2008; – 31.0% reduction 24(10):2905-18 – 83% responder rate – SLT = $4,838 • Control – Medication = $6,571 – 30.6% reduction – 84% responder rate – Surgery = $6,363 ***5-year cumulative costs
McIlraith, Ian MD*; Strasfeld, Maurice MD; Colev, George MD et. Al. Journal of Glaucoma: April 2006 - Volume 15 - Issue 2 - pp 124-130
Cost Considerations Peripheral Iridotomy (PI)
• Lee R, Hutnik CM. Projected cost comparison of selective laser trabeculoplasty versus glaucoma medication in the Ontario Health Insurance Plan. Can J Ophthalmol 2006 Aug;41(4):449-56 – Monotherapy $ 206.54 – Dual therapy $1,668.64 – Triple therapy $2,992.67
***Assumed 2 year repeat SLT rate, 6 year cumulative saving vs.
Glaucoma: Laser Treatment Considerations for Optometry
• Open or Narrow Angle Glaucoma • Laser therapy remains a viable option – Transcleral Cyclophotocoagulation • Can be used as primary or secondary treatment
• IOP lowering of 20 - 25%
• Glaucoma comanagement considerations
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Advances in Glaucoma Surgery Cataract and Glaucoma
• Evolution of small-incision phacoemulsification • How to position the cataract operation in the techniques and small-profile IOLs management scheme of the patient’s glaucoma – Smaller wounds, less inflammation condition? • Using antimetabolites to enhance filtration surgery – MMC intra-operatively • Is it better to choose one sequence and type of – 5-FU post-operatively with needling/injections surgery before the other, or to combine two • Availability of novel glaucoma procedures procedures? – Non-penetrating glaucoma surgeries (Trabectome, canaloplasty) • STRESS the IMPORTANCE of visual fields PRIOR to – Endocyclophotocoagulation cataract surgery
The Effects of Phacoemulsification on Intraocular Pressure and Topical Medication Use in Patients With Glaucoma: A IOL Choices in Glaucoma Systematic Review and Meta-analysis of 3-Year Data. • Purpose: For patients with comorbid cataract and “Yes – I would like to be free from glasses!” primary open-angle glaucoma (POAG), guidance is lacking as to whether cataract extraction and STANDARD traditional filtering surgery should be performed as a staged or combined procedure TORIC MULTIFOCAL – A 12%, 14%, 15%, and 9% reduction in IOP from baseline occurred 6, 12, 24, and 36 months after phacoemulsification – A mean reduction of 0.57, 0.47, 0.38, and 0.16 medications per patient of glaucoma medication occurred 6, 12, 24, and 36 months after phacoemulsification
Armstrong, JJ, Wasiuta, T, and Kiatos, E. et al. Journal of Glaucoma: Post Author Corrections: March 22, 2017
Trabeculectomy
• Traditionally done when meds and/or lasers fail to adequately control the pressure
• In advanced cases can be first line mode of treatment
TRADITIONAL GLAUCOMA • Gold Standard Surgical technique SURGERY – Long history – Low eye pressures – Reduce or eliminate medications and costs
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Candidates for Trabeculectomy Trabeculectomy Procedure
• Optic nerve progression despite MMT and/or LT • Surgical exposure • Conjunctival flap • Visual field progression despite MMT and/or LT • Scleral flap - +/- antifibrosis agent • Sclerostomy • Inability to take drops adequately • Iridectomy – needed to prevent the iris from incarcerating into • Target pressure is LOW the internal ostium • Scleral flap closure • Moderate/advanced disease • Conjunctival closure
Trabeculectomy Complications Tube Shunt and Cataract Surgery
• Scar formation-failure • Bleb leak • Blurring of vision • Hypotony • Choroidal hemorrhage • Infections • Cataract formation
Standard Surgical Treatments Tube Shunt Advantages Tube Shunt- Advantages • Safer for contact lens wearers • Safer for contact lens wearers • More standardized post operative care • More standardized post operative care • Used when previous trabeculectomy failed • Used when previous trabeculectomy failed • Results comparable to trabeculectomy
• Results comparable to trabeculectomy
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TVT Study TVT Study 1 Year Results
• Trabeculectomy (with MMC) vs Tube study • Tube success (96.1%) vs trab/MMC (86.5%) (non-valved Baerveldt) – Prior surgery required • More complications in trab group(57% vs 34%)
• Nationally the relative amount of trabs being • Although similar levels of IOP were observed, done is decreasing more adjunctive medical therapy in the tube group • Tube procedures are increasing
TVT Study What Do You Get When You • 3 year IOP lowering about the same Add?
• At 3 years trabs are twice as likely to fail than tubes +
• Trabs often suffer from hypotony in the short term and more complications in the long term
• Can usually wear contacts after tube SX Great Candidate for MIGS/PHACO
Concomitant Cataract & Glaucoma Patients Significant Treatment Opportunity One in five Cataracts Eyes on OHT Medication 20.5% Cataract + 3.5M US Cataract Procedures “The new MIGS procedures are to trabeculectomy what Minimum phacoemulsification was to intracapsular cataract extraction or of 1 OHT 718K LASIK was to RK.” Med
79.5% Cataract
Cataract Pts Cataract Pts w/ Glaucoma Only Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File. Baltimore, MD. 2007 84 . PN: 400-0122-2013- Release Date:
US Rev 0 04/26/2013
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QUALITY-OF-LIFE ISSUES Cataract and Glaucoma
• Improved quality of vision • How to position the cataract operation in the • Less dependence on management scheme of the patient’s glaucoma glasses / contact lenses condition?
• Patients now • • More demanding Is it better to choose one sequence and type of surgery before the other, or to combine two • More knowledgeable procedures? • More sophisticated • More informed • STRESS the IMPORTANCE of visual fields PRIOR to cataract surgery
Patients looking for better outcomes and quality of life - your practice can offer this!
Minimally Invasive Glaucoma Surgery (MIGS) Ab Externo Ab Interno • Canaloplasty • Glaukos iStent “The new MIGS procedures are to • Stegmann Canal • Neomedix Trabectome trabeculectomy what phacoemulsification was to Expander • Excimer laser intracapsular cataract extraction or LASIK was to • Gold Microshunt trabeculotomy RK.” • Hydrus Microstent • Cypass Microstent*** • Kahook Dual Blade • Xen Gel Stent***
Pathway for Trabecular Bypass Devices Anatomical Considerations
• Shunting the canal • Dilating the canal – Express MiniShunt – Visco 360 / Ab-Interno (Alcon) Canaloplasty (ABIC) • Stenting the canal • Divert aqueous into the – iStent (Glaukos Corp) suprachoroidal space • Reduce aqueous – Cypass Microshunt (Alcon) production Trabectome – Endocyclophotocoagulat • Divert aqueous into the ion subconjunctival space – Xen Gen Stent (Allergan)
Photo accessed from http://www.downstate.edu/ophthalmology/patient-info/patient-info-glaucoma.html PN:on 11/4/16400-0135 -2013-US Rev. 0 Release Date: 08/27/2013
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Are Patients Interested in MIGS? MIGS ADVANTAGES Safer Avoids serious complications • 28pts Gentler Less OR time • 79% did not mind instilling Faster recovery drops Reduction of IOP Less glaucoma meds • 64% did not mind wearing Decreased IOP fluctuations glasses Combined with cataract sx No Bleb • 86% were interested in Spares the conjunctiva reducing their need for Good for contact lens topical medications wearers Fewer follow-up appointments
Trabectome Video by Constance Trabectome - IOP & Glaucoma Medication Use Okeke, MD Outcome IOP (mmHg)
Mean pre-op IOP
Mean IOPs with standard deviations at various intervals after surgery over 72 months Glaucoma Medication Use
Mean pre-op medication use
Mean medication use after surgery over 72 months
Istent Video Courtesy of Constance US IDE Trial - Primary Endpoint Okeke, MD, MSCE Percent of Patients With IOP ≤21 mm Hg Without Medication Use
100
80
60 72% 40 50%
20
0 Cataract Surgery iStent®
At 12 months, 72% of iStent® subjects with IOP ≤ 21 mm Hg without medication vs. 50% with cataract surgery alone (P<0.001)
Caution: Investigational device limited by Federal (U.S.) law to investigational use only. 96
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iStent + Phaco iStent + Phaco Ferguson, Berdahl, Schweitzer et. al Ferguson, Berdahl, Schweitzer et. Al. Retrospective Case Series Retrospective Case Series n=107 at 2 years IOP reduction higher with higher baseline IOP
Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of trabecular microbypass stents with phacoemulsification in patients with open-angle glaucoma Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of trabecular microbypass stents with phacoemulsification in patients with open-angle glaucoma and cataract. Clinical Ophthalmology 2016:10 1767-1773 and cataract. Clinical Ophthalmology 2016:10 1767-1773
ICE, ICE Baby Kahook Video by Constance Okeke, Video Courtesy of John Berdahl, MD and Justin Schweitzer, OD MD
The XEN® Gel Stent The XEN® Procedure • A glaucoma implant designed to reduce intraocular pressure in eyes suffering from refractory glaucoma1 • 6-mm length, 45-micron inner diameter—about the length of an eyelash1,2 • Composed of gelatin, cross- linked with glutaraldehyde1
In the clinical investigation, standard ophthalmic surgery techniques, viscoelastic, and mitomycin C (0.2 mg/mL) were 1. XEN® Directions for Use; 2. Vogt et al. In: Blume-Peytavi et al, eds. Hair Growth and Disorders. 2008. 1. XEN® Directionsused for before Use. injection.1
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The XEN® Procedure Creates a Low- Lying, XEN® Ab-interno Bleb Examples Ab-interno Bleb in Refractory 1 Ab-Externo BlebGlaucoma Ab-Interno Bleb
Controlled flow through lumen Suture wounds2 restriction1 Dissected tenon Tenon capsule adhesions intact1 capsule layer2 Undistrubed, low-lying Diffuse, mildly drainage space1 elevated bleb2
• Example of elevated, cystic • Low-lying and Post-op month 18 bleb2 diffuse1 Post-op day 1 Post-op month 12 1. Dapena and Ros. Revista Española de Glaucoma e Hipertensión Ocular. 2015; 2. Errico et al. Clin Ophthalmol. 2011. Actual patient. Images courtesy of: Francisco Millan, MD, and Vanessa Vera, MD.
Established Effectiveness at 12 Months Cypass Microstent
• Ab-interno insertion into the supraciliary space • Fenestrated microstent made of biocompatible polyimide material
76.3% (95% CI = 65.8%, 86.8%); -6.4 ± 1.1 (95% CI = -8.7, -4.2); using • Magnetic resonance using observed data and failures for observed data and worst within-eye IOP for subjects with glaucoma-related subjects with glaucoma-related secondary safe secondary surgical intervention and surgical intervention and multiple multiple imputations for missing data imputations for missing data (N = 65).1 (N = 65).1
1. XEN® Directions for Use.
CyPass® Micro-Stent: Enhanced Why Target the Uveoscleral Outflow Aqueous Outflow . The supraciliary space has a negative Pathway? pressure gradient that drives aqueous • Uveoscleral outflow: outflow and considered pressure reduction of intraocular pressure1 independent and contributes up to 50% of total aqueous . The uveoscleral pathway bypasses outflow.2 Schlemm’s canal and collector channels, which may be atrophic • Aqueous percolates through in glaucoma patients2 the ciliary body and exits into the suprachoroidal . The CyPass® Micro-Stent utilizes space, primarily through the the same outflow pathway as first sclera and choroidal blood 3 line prostaglandin analogues vessels.3 • The highest point of
1. Saheb H, Ianchulev T, Ahmed I. Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open-angle glaucoma. Br J Ophthalmol. 2012;98:19–23. resistance is the ciliary body, 2. Fellman. Episcleral venous fluid wave correlates with the type and extent of canal-based surgery. AGS 2014 abstract. 3. Weinreb RN, Toris CB, Gabelt BT, et al. Effects of prostaglandins on the aqueous humor outflow pathways. Surv Ophthalmol. 2002;47(Suppl 1):S53–S64. which is thought to regulate this drainage.3
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Clinical Data Delivers superior, long- term IOP-lowering efficacy And There’s More Two-year COMPASS Trial is the largest MIGS randomized controlled trial completed to date Landmark FDA study with two-year follow-up on >500 patients with baseline/terminal washout • Canaloplasty • 72.5% of • 61.2% of • Glaukos Istent Supra eyes eyes achieved maintaine • SolxGlaukos Gold Shunt Istent Inject a ≥20% d an • Allergan Bimatoprost SR reductio unmedicat n in ed diurnal • Ocular Therapeutix SR unmedic IOP Travaprost ated range diurnal between IOP 6 and 18 at 2 mmHg years* at 24 months
*Prospective, randomized, multicenter clinical trial in patients (n=505) with open-angle glaucoma undergoing cataract surgery randomized to Kahook Dual Blade microstent (n=374) or phacoemulsification (n=131). (a 41% Primary outcome measure was unmedicated diurnal IOP reduction at 24 months versus cataract surgery alone at baseline. Secondary outcomes measures included mean change in 24 month increase)* DIOP from baseline and 24 month unmedicated mean IOP (between 6 mmHg to 18 mmHg) versus cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using intent to treat (ITT) population.
Post-operative Cataract IOP Spikes in How To Choose Which Procedure? Glaucoma Patients • Discuss with your surgeon which procedures • Adequate control prior to surgery they perform? – Additional drops • Based on Stage and Severity – SLT prior – Moderate to advanced cases – Trabectome, Xen • Consideration of combined glaucoma and – Early to Moderate – iStent, Cypass cataract procedures – Multiple iStents off label?? • Aggressive treatment perioperatively
– Diamox at the end of the case, early post-op • Closer follow-up post-operatively
Glaucoma Drops On the Horizon Latanoprostene bunod (VESNEO) New Drug Company Type Latanoprostene bunod Bausch + Lomb Nitric oxide – donating • prostaglandin F2-a-analogue A nitric oxide-donating prostaglandin F2-a analogue Rhopressa Arie Inhibits Rho kinase and norepinephrine transporter that reduces IOP in patients with open angle glaucoma Roclatan Arie Rhopressa + latanoprost and ocular hypertension
Trabodenoson Inotek Highly selective adenosine mimetric acting only at A1 • Dual Action receptor subtype – Latanoprost derivative – OTX-TP Ocular therapeutix Sustained release travoprost increases uveoscleral outflow punctal plug – Nitric Oxide - relax the trabecular meshwork and Bimatoprost Sustained Allergan Intracameral sustained release ciliary muscle to increase Release bimatoprost trabecular outflow
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Latanoprostene bunod (VESNEO) Rhopressa
• Improved IOP lowering profile compared to latanoprost • “Triple Action” IOP and timolol lowering – Phase 3 trials: reduced mean IOP by 7.5 to 9.1 mm Hg – Rho Kinase inhibitor from baseline between 2 and 12 weeks of treatment. • Increase trabecular outflow • The safety of latanoprostene bunod was comparable to – Norepinephrine latanoprost, with the most common adverse event’s Transport Inhibitor being mild hyperemia, which occurred at a similar rate • Reduces aqueous across all treatment groups production – Decrease episcleral • Release date: Fall 2017 venous pressure
http://investors.aeriepharma.com/releasedetail.cfm?releaseid=908343
Rhopressa Roclatan
• Finished phase 3 trials, once-daily dosing • Rhopressa + latanoprost = Roclatan reduced IOP by 5-6mmHg • “Quadruple Action” – The primary adverse event was – Reduces aqueous production hyperemia, which was experienced by – Increases trabecular outflow approximately 35% of the Rhopressa – Increases uveoscleral outflow patients – Decreases episcleral venous pressure • 80% was reported as mild
Aerie Pharmaceuticals. Aerie Pharmaceuticals reports Roclatan phase 2b results achieve all clinical endpoints. June 25, 2014. http://investors.aeriepharma.com/releasedetail.cfm?releaseid=908343 http://investors.aeriepharma.com/releasedetail.cfm?ReleaseID=856396.
Roclatan Trabodenoson
• Phase 3 Clinical Trials • Stimulation of adenosine A1 receptor in the – Lowered mean diurnal IOP on day 29 by 34% from trabecular meshwork upregulates proteases (MMP2) a baseline of 25.1 to 16.5 mm Hg. that digest and removes proteins that clog the – IOP-lowering effect exceeded that of latanoprost trabecular meshwork by 1.6 to 3.2 mm Hg across each time point – Increases trabecular outflow evaluated during the study, and these results were
statistically significant at all time points. – The most common adverse event with Roclatan was hyperemia, which was reported in 40% of patients and scored as mild for most of them.
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Bimatoprost Sustained Ocular Therapeutix Release Implant
• Sustained-release travoprost in an intracanalicular • Phase 2 trial comparable depot composed of polyethylene glycol hydrogel and to topical bimatoprost drug-containing microparticles qdaily dosing (for 4-6 – Drug elutes over 90 day period months) – In Phase 3 Clinical Trials • Inserted into the anterior chamber • Biodegradable • Allergan is currently performing phase 3 clinical trials
Ocular Therapeutix. Sustained release travoprost. http://www.ocutx.com/pipeline/travoprost-punctum-plug
Ocular Science Glaucoma Drops Case Example – POAG / MGD
• 76YOWF – Present for follow up for Glaucoma and dry eye disease. Compliant with drops OU. Vision has been blurry and eyes irritated $25.00/ 1 month supply $30.00/ 1 month Supply more in the past few months – Previous treated with topical azithromycin • 180 day shelf life – Current Ocular Meds: Restasis BID OU, • 0.02% BAK latanoprost qhs OU preservative – Numerous systemic meds including singulair,
$35.00/ 1 month supply • Ships directly to synthroid patient
• SPEED Score: 33 • Tear Osmolarity 308 / 315 • SLE: 2+ MGD OD / 3+ MGD OS / 1+ SPK OU • Cloud secretions OU • MG Structure: See images • IOP: 14/13 Early to Moderate Structural Advanced Gland Atrophy / Dropout • HVF: Stable OU Changes to Meibomian Glands
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Post Treatment OSD and Glaucoma Considerations
• 6 Weeks Post Treatment • Post Tx Osmolarity • Glaucoma medications significantly – 300/299 elevate the risk and progression of • Post Lipiflow Management MGD1 – Heat masks qhs OU – Hydroeye as directed 2 – Restasis BID OU • Preservative and dry eye
– Lipid based tear BID OU – Latanoprost qhs OU • Glaucoma and MGD: 96% (using – F/u 3 months dry eye Prostaglandins) had obstructive • Order tear osmolarity MGD vs. 58% of those on non • Order inflammadry 3 • SPEED Questionnaire Prostaglandin Therapy.
1. Arita R, Itoh K, Maeda S, et al. Comparison of the long-term effects of various topical antiglaucoma medications on meibomian glands. Cornea. 2012 Nov 31(11): 1229-34. 2. Baudouin, C, Labbe, A, Liang, H, et. Al. Preservatives in eyedrops: The good, the bad and the ugly, Progress in Retinal and Eye Research, Volume 29, Issue 4, July 2010, Pages 312-334 3. Mocan MC, et al. The Association of Chronic Topical Prostaglandin Analog Use With Meibomian Gland Dysfunction. J Glaucoma. 2016 Sep;25(9):770-4.
Focus on Dry Eye Prevalence
• Cataract Surgery 77% • Penetrating Keratoplasty 60% • Lasik 27% • Glaucoma Surgery 78% • Blepharoplasty 26%
Trattler, ASCRS CME Supplement, 2013 Sheppard, WCC, 2015 Azuma, BMC Research Notes, 2014 Leung, Journal of Glaucoma, 2008 Prischmann, JAMA Facial Plastic Surgery, 2013
Conclusions
• Glaucoma Dx / Tx is constantly advancing
• Consider benefits of MIGS
• Address the ocular surface THANK YOU • Anticipate continuous innovation [email protected]
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