3/11/2017

Disclosures

 I have no financial ties or relationships to any of the companies or products (Eye)Drop It Like It’s Hot mentioned in this lecture.  Although if one wants to give me money, I will listen. New & Exciting Advancements in

Adam T. Shupe, O.D Royo Eye Care Marysville, CA [email protected] @DrShupe

You Probably Don’t Have Glaucoma… Glaucoma As We Know It – Statistics

 It is estimated that over 3 million Americans have glaucoma  Approximately 50% have been diagnosed and are being treated  Increased prevalence among ethnic groups  African American, Hispanic, Indian, Asian American  Many different types of glaucoma  Primary open angle  Narrow angle  Angle closure  Uveitic  Pseudoexfoliative  Pigmentary  Pediatric  Not all are treated the same!

Glaucoma As We Know It - Medications

 There are over twenty branded medications used to treat glaucoma

 Approximately half are available in an variety of generic substitutes

 Even cap color is not a guaranteed identification anymore!

 The last novel glaucoma medicine () was released in 2012 So what’s next…?  All other recently released products are PF or combinations of existing medicines

 But new medicines are on the horizon!

 It is our responsibility to stay informed!

1 3/11/2017

New Meds #1 – Tafluprost 0.0015% New Meds #2 – 1%/ 0.2%

 First preservative-free glaucoma medication  First non- combination medication

analog  Dosed one drop, three (or two) times per day  Dosed one drop, every evening  Combines industry-leading 2nd line treatments  Carton of 30 vials, separated into three foil pouches  Who is a good candidate?  Unopened pouches should be refrigerated  Adjunct therapy to PGAs  Opened pouches may be left unrefrigerated  Prostaglandin analog allergy  Who is a good candidate?  Beta-blocker contraindication  Young glaucoma patients

 Multiple medication patients

 Perioperative patients

 Multiple allergy patients

New Meds #3 – HCl 2%/Timolol Maleate 0.5% New Meds #4 – Isopropyl 0.15%

 Non-preserved version of existing medicine  Reformulation of original medication from 2000

 Dosed one drop, two (or three) times per day  Concentration increased from 0.12% to 0.15%

 Carton of 60 vials, separated into four foil pouches  Reclassified as docosanoid, not prostaglandin

 Unopened pouches should be refrigerated  Increases outflow through

 Opened pouches may be left unrefrigerated  May affect BK and ClC-2 channels as well

 Available in 180-count, three-month supply carton  Effective reduction in IOP with limited side effect  Who is a good candidate?  Less systemic effect than most adjunct therapies  Same patient profile as Zioptan  Similar side effect profile to  Pre-existing Cosopt users

New Meds #5 – 0.02% New Meds #6 –Latanoprostene Bunod 0.024%

 Rho-kinase inhibitor  Novel compound with dual-action IOP-lowering effect

 First new class of glaucoma medications since 1996  Addition of nitric oxide-donating moiety to  “Triple Action” IOP-lowering capability  Nitric oxide relaxes trabecular meshwork, increasing outflow  Inhibits Rho-kinase (ROCK)  Combines with PGA effect to produce significant IOP-lowering effect  Increases trabecular meshwork outflow

 Reduces episcleral venous pressure

 Inhibits Norepinephrine Transporter (NET)  Has completed Phase III trials, awaiting FDA approval

 Decreases aqueous production  However, delayed in July 2016 due to manufacturing concerns  Potentially mid-to-late 2017 for FDA approval

 Likely to be combined with latanoprost  NicOx also working on a solo nitric-oxide donator  Holds promise to be most efficacious glaucoma medication ever!  Would avoid adverse effects of PGAs

2 3/11/2017

New Meds #7 – Trabodenoson New Meds #8 – Ripasudil 0.4%

 Adenosine (A1) receptor agonist  Rho-kinase inhibitor  Receptors found in the trabecular meshwork  Already in use in Japan, launched December 2014  Upregulates proteases that reduces protein accumulation in the TM  Mechanism of action the same as netarsudil  May also exhibit neuroprotectant properties  Dosed one drop, two times per day  Study showed protection against ischemia-induced ganglion cell loss Now with latanoprost!  Also may be paired with latanoprost in combination drop  Unknown if product will be brought to the U.S.

 Currently in Phase III trials

 Other companies also investigating drugs in this new class

New Meds #9 – Alphabet Soup New Meds #10 – Lomerizine

 AMA0076: ROCK-inhibitor, in Phase II trials since 2012  Oral calcium channel blocker

 Alleged to produce significantly less hyperemia  Targeted vasodilating effect with affinity for cerebral and neural tissues

 OPC-1085EL: latanoprost/, Phase III ongoing  Increases blood flow without significantly lowering blood pressure  Currently marketed in Japan as a treatment for migraines  Registered in Japan in September 2016  Increased blood flow may provide neuroprotectant effect against ischemia  DE-117: omidenapag isopropyl, Phase III upcoming

 Non-prostanoid selective EP2 receptor agonist  Phase II trials ongoing in Japan

Endoscopic Cyclophotocoagulation (ECP) New Drug Delivery Systems

 Sustained-release drug therapies are on the horizon  Minimally invasive glaucoma surgery (MIGS)

 Avoids patient adherence issues  Ciliary processes photocoagulated

 Intracameral depots  Often performed intraoperatively

 ENV515 is in phase II trials  Fiber optic camera probe with laser

 Utilizes extended-release  Reduces aqueous production

SR is in phase III trials  Generally 270 degree arc treated

 External devices  Potentially opens narrow angles

 Helios is a bimatoprost-laden polymer ring  Advantages:

 Sustained delivery for six months of wear  Very low risk profile

 Drug-eluting punctal plugs also under development  Easy to perform (approx. five min)

 OTX-TP is biodegradable intracanilicular travoprost (Phase III)  Disadvantages:  Evolute is latanoprost-eluting parasol plug (Phase II)  Slight IOP drop

 CI: PXE and uveitic glaucoma

3 3/11/2017

More MIGS Glaucoma As We Know It - Technology

 Glaucoma shunt devices proliferating

 Physically inserted intraoperatively  Managing glaucoma is more than just checking IOP!  Location, location, location  Visual Field testing  iStent: trabecular meshwork

 Hydrus: Schlemm’s canal  Gonioscopy

 CyPass: suprachoroidal space  Fundus photography

 XEN: subconjunctival space  Pachymetry  iStent Inject: trabecular meshwork And…  iStent Supra: suprachoroidal space  Ocular Coherence Tomography (OCT)

Advancements in OCT Technology All The Pretty Pictures

 Significant improvement in quality

 Faster, less blink artifact

 Clear image without dilation

 Less technician-dependent

 No targeting, cube of information

 More versatility in testing

 Pachymetry

 Angle imagery

 Progression modules available

 RNFL trend analysis

Going Where No OCT Has Gone Before New IOP-Monitoring Technology

 Triggerfish approved by FDA in March 2016

 Microsensor-embedded high-dK silicone SCL

 Time Domain OCT -> Spectral Domain OCT -> Swept-Source OCT  Gauges fluctuations in corneal circumference secondary to ocular  ~1,000 nm wavelength allows deeper penetration into tissues  Mathematical relationship to IOP – not actual mmHg  Deeper scan captures more information (i.e. choroid, sclera, lamina cribosa)

 Better signal strength through media opacity (i.e. cataract, hemorrhage)  Takes ~300 measurements (once every 5 minutes)

 Also invisible to the eye -> no distracting laser sweeps  Data transmitted to periocular antenna

 Capable of ~100,000 A-scans per second connected to wearable recorder

 Compared to SD (~20,000-70,000 scans) and TD (100-400 scans)  Data downloaded from recorder after 24 hours

 Gathers more information over a larger scan window  Lens is single-use only, must be discarded

 Important for scanning patients with difficult fundi  Available in BC 8.4 mm, 8.7 mm, 9.0 mm

 Not yet commercially available in U.S.*  Cost: $9,000 for system, $1,000 for one setup

 CPT 0329T “Monitoring of IOP >24 hours”

 May change our profession’s approach to IOP

4 3/11/2017

Now What? How Do I Manage? Repeat Test Example

24-2, April 2013 24-2, May 2013

After initial diagnosis, every three months…

 Office visit with visual field testing

 Dilated exam with fundus photos

 Office visit with gonioscopy

 Annual exam with OCT

 Rinse and repeat

 Don’t be afraid to test!

 Don’t be afraid to repeat test!

So, How Do I Get Paid? Show Me The Money! 2016 Medicare Reimbursement, Los Angeles Area

 Step #1: Get on medical insurance panels  CPT 92133, OCT Optic Nerve: $49.32

 Always get updated medical insurance information  CPT 92083, Visual Field, Extended: $73.02

 Step #2: Never “just run a test”  CPT 92020, Gonioscopy: $29.58

 Your patients (and your wallet) will appreciate it!  CPT 92250, Fundus Photos: $90.31

 Step #3: Don’t be afraid to binge test  CPT 76514, Pachymetry: $17.00  Do not let glaucoma walk out the door

 Step #4: Repeat tests as necessary  One full glaucoma work-up: $259.23  Do not make decisions based on unreliable data

Typical Glaucoma Management Cycle Who To Refer To? 2016 Medicare Reimbursement, Los Angeles Area

 Schedule every three months!  What is the reimbursement?  Your friendly local glaucoma-certified optometrist!

 Many of us are well-qualified and eager to manage glaucoma

 January: Full exam + OCT  92014 + 92133 = $187.64  Referring solely to ophthalmology damages our efforts to expand scope

 April: Office visit + Visual Field  92012 + 92083 = $168.67

 July: Dilated exam + Disc Photos  92014 + 92250 = $228.63

 October: Office visit + Gonioscopy  92012 + 92020 = $125.23

 Rinse and Repeat!  Total: $710.17/year

5 3/11/2017

When To Refer To OMD Questions? (Softballs Only)

 Angle closure (after IOP is controlled)

 Narrow angles (LPI)

 Surgical candidate

 Poor compliance with medication

 Progression despite maximum medication

 Cannot afford medications

 SLT, MIGS, trabeculectomy all possible

Thank You!

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