MIGS is Growing Up: How MIGS Procedures are Revolutionizing Glaucoma Treatment
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This document discusses microinvasive glaucoma surgery (MIGS) and the growing market potential for MIGS devices. It provides an overview of current glaucoma treatment options and their limitations. The author estimates that there are currently around 250,000 glaucoma surgeries performed annually in the US, but that the potential market for MIGS devices could be much larger given the number of glaucoma patients on multiple medications who could be candidates for MIGS. Financial data is presented for one company demonstrating the growth in the MIGS market.
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MIGS is Growing Up: How MIGS Procedures are Revolutionizing Glaucoma Treatment
- 1. MIGS is Growing Up Ike K Ahmed MD University of Toronto
- 2. IK Ahmed MD Disclosures AdeTherapeutics: C Accelerated Vision: C ACE Vision Group: C Alcon: C, R AMO: C, R, S Aerie: C Allergan: C, R Aquesys: C, R Bausch & Lomb: C Carl Zeiss: C, R, S Clarity Medical Systems: C Croma Pharma: C Envisia Therapeutics: C Eyelight: C ForSight Labs: C Glaukos: C, R, S InnFocus: C Iridex: C, R Ivantis: C, R, S LayerBio: C New World Medical: R Omega Ophthalmics: C ONO Pharma: C PolyActiva: C Sanoculis: C Science Based Health: C SOLX: C, R Stroma: C Transcend: C, R TrueVision: C C = Consultant R = Research Support S = Speakers Honorarium
- 4. IK Ahmed MD Interventional Glaucoma Medications Lasers Trabeculectomy / Tubes MicroInvasive Glaucoma Surgery
- 5. Cardiovascular Medicine Coronary Stents CABGMeds
- 6. IK Ahmed MD Defining MIGS • Ab-interno approach • Minimally traumatic • At least modest efficacy • Extremely high safety profile • Rapid recovery
- 7. IK Ahmed MD Outcome Measures Lower IOP & eliminate/reduce meds
- 8. IK Ahmed MD 3 MIGS Outflow Targets Schlemm’s Canal Conventional Outflow iStent iStent inject Hydrus Trabectome Goniotomy Suprachoroidal Space Non-conventional Outflow Cypass + Cypass Vx iStent Supra Scleral/Subconjunctival Xen MMC
- 9. IK Ahmed MD
- 10. IK Ahmed MD
- 12. GKOS (NYSE): Financial Strength to Support Continued Global Growth TOTAL NET SALES (in millions) $0 $6 $11 $17 $22 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 $91.1as of 12/31/15 CASH, CASH EQUIVALENTS & SHORT-TERM INVESTMENTS (in millions) $21.0M $45.6M $71.7M
- 13. IK Ahmed MD How Big is the Market? Current? Potential?
- 14. IK Ahmed MD Understanding the Market Combo cataract surgery 700K / year Standalone procedures ?2+M / year
- 15. IK Ahmed MD 80% 21% Comorbid Cataract & Glaucoma • 15-20% of patients undergoing cataract surgery have glaucoma • 3.7 million cataract surgeries in the US per year • 500-700,000 comorbid with glaucoma Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File. Baltimore, MD. 2007 Tseng, V. L., Yu, F., Lum, F., & Coleman, A. L. JAMA. 2012;308:493–501.
- 17. IK Ahmed MD US Glaucoma Prevalence 2% over 40yo 3M —> 6M
- 18. 3Million US Glaucoma Patients 140K Trabs/ Tubes 500K Lasers Potential MIGS Large Treatment Gap and Opportunity in Glaucoma Intervention
- 19. >=2meds, 1,011,408 SLT/ALT Laser, 541,998 Trab/Tube, 110,000 MIGS/Other s, 123,200 Glaucoma Treatment Methods Potential MIGS Patients Marketscope >=2meds, 5,085,230 SLT/ALT Laser, 1,902,897 Trab/Tube, 371,300 MIGS/Other s, 197,734 US Patients Global
- 20. <0.65 >-6dB 0.7-0.85 -6 to -12dB 0.9+ <-12dB/10° Fixn Glaucoma Disease & Prevalence Mild Moderate Advanced 0.3 OHT 2million 1.5million 750,0003million Marketscope
- 21. IK Ahmed MD The Glaucoma Pyramid: Target IOP Guides Therapy Safety Highest Priority Safety and IOP lowering needed Max IOP lowering needed 1.5M 2.0M 750K 3.0M USPopulation 12 15 18 21 TargetIOP(mmHg)
- 22. IK Ahmed MD What is the Incidence of Glaucoma?
- 23. IK Ahmed MD The Cycle of Glaucoma Therapy • Glaucoma is a life-long chronic disease • Re-treatment rates are high • Multiple drops and interventions over a lifetime ~ 200K newly diagnosed glaucoma per year
- 24. IK Ahmed MD
- 25. IK Ahmed MD Glaucoma Treatment Algorithm 1 Med Multiple Meds SLT Multiple Meds Trab 2nd Trab or Tube 1 Med SLT Drug Delivery MIGS MIGS Plus Trab or Tube Phaco + MIGS Now & Potentially in 5 years Level of Invasiveness
Editor's Notes
- 60million people worldwide with glaucoma (US 3-4M) —> 80MM in 2020. 2nd leading cause of blindness worldwide $6billion dollar market currently and growing (US $2.5B) … but our current therapies are suboptimal…. Br J Ophthalmol. Mar 2006; 90(3): 262–267. doi: 10.1136/bjo.2005.081224 PMCID: PMC1856963 The number of people with glaucoma worldwide in 2010 and 2020 H A Quigley and A T Broman Marketscope
- The gap in current glaucoma care is very evident (BTW, if u google images for “Gap”….) Adherence, side effects, costs with topical meds 50-60% don't take their drops properly! associated with vision loss Surgery: blebs — early and long-term complications…. a reason why we don’t rush off to do traditional GL sx!!??
- stents billion dollar market
- Invasiveness = not just incision size. Level of disruption of normal anatomy/physiology/integrity of eye - Typically corneal approach into angle, no conj incisions - Negligible disruption of normal anatomy/physiology Excellent biocompatibility mostly micro-stenting (cardiac, neuro, pulmonary, urological, vascular STENTING) Keep door open for more aggressive surgery
- All differ on risk/reward/effort Common hallmark of MIGS has been micro-stenting (but that is not exclusive).
- Era of microstenting Transcend $80M Ivantis $107M AQS $77M GKOS $150 InnFocus $35M = $450M <almost half a billion $> …15 years ago was pretty well nothing…
- Allergan $300M + milestones Alcon $241M + milestones to $359M “2016 Alcon – Acquisition of Transcend Medical, Inc. On February 17, 2016, Alcon entered into an agreement to acquire Transcend Medical, Inc. (Transcend), a privately-held, US-based company focused on developing minimally-invasive surgical devices to treat glaucoma. The transaction closed on March 23, 2016, and the fair value of the total purchase consideration was USD 352 million. The amount consisted of an initial cash payment of USD 241 million and the net present value of the contingent consideration of USD 111 million due to the Transcend shareholders, which they are eligible to receive upon achievement of specified development and commercialization milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 326 million and goodwill of USD 26 million. Results of operations since the date of acquisition were not material.”
- reimbursement .. successful CPT code … and regulatory approval
- And how do the devices differentiate from each other?
- “Cataract plus”..while the initial market is MIGS/phaco —(already in the eye, minimal additional risk of MIGS)…. the eventual market will include both MIGS/phaco and MIGS as “standalone” (3-5x the phaco market) Standalone may be 3-5X greater than combo cataract The dominant device in phaco must be highly safe; the dominant device in “standalone” must be safe but also effective
- (US incidence GL = 2-3million) Large market
- Annual (140K traditional) c.f. glaucoma lasers: 550,000. Cataract: 3.7MM
- Let’s look at prevalence to get some idea about market size… (BTW: TWO eyes per patient) In 2010, glaucoma affected about 1.9 percent of people in the U.S. age 40 and older. Black Americans had the highest prevalence rate (3.4 percent) followed by Americans of other races (2.1 percent), whites (1.7 percent) and Hispanics (1.5 percent). The prevalence of glaucoma increases with advancing age. Black Americans age 40 and older are at the highest risk of developing the disease compared with people of other races. By age 69, nearly six percent of black Americans have glaucoma; their risk rises to nearly 12 percent after age 80. From 2010 to 2050, the number of people in the U.S. with glaucoma is expected to increase by more than double, from 2.7 million to 6.3 million. NEI
- These are patients… most have glaucoma in both eyes… x2 re: potential market… Laser surgery provides marginal and temporary IOP lowering. Trabeculectomy gold standard but saved for the most advanced patients due to it’s safety profile MIGS represents the largest opportunity. Technology with best risk/benefit profile will appeal to the most providers
- Annual (140K traditional) c.f. glaucoma lasers: 550,000. Cataract: 3.7MM
- Hodapp Anderson Parrish criteria
- Most MIGS devices play in the middle (and large) area…. drops primarily for OHT… If doing cat sx, could be anywhere on spectrum if can reach target IOP Surgeons will accept more risk to get to lower targets; they will accept little to no risk for mild patients
- if prevalence is 3-4M, what is the incidence… after all, once you operate on all these patients, what’s left? Incidence in phaco/glc is clear…..we know the volume of phacos each year…..so extrapolating MIGS there is doable – its clearly somewhere between 10% and 20%. Standalone is more challenging….on the face, it seems much bigger – but that 3.5 MM glaucoma population in US today is a prevalence number (BTW, GKOS quotes standalone in US as 5 MM, not 3.5 MM)….fair to say screening will be more commonplace in future, as will early detection, so standalone number will grow and be bigger…. But point is….one the initial pool is worked through, what is the ongoing annual number of new glaucoma diagnosis, because that is what “replenishes the pool.” In the William Blair report, they say over 100,000 new diagnoses per year….which is actually smaller than the possible US cataract/MIGS annual number of 20%x 3.7 MM (740,000). That annual standalone is tough to peg…even Kuldev, who has all the data, said its a guess, but he estimates 100,000 new glc patients enter pool per year….I believe William Blair report here estimates about 150,000 per year. I am not sure if I would say this from podium, but, just so you understand, while everyone says standalone will be WAY bigger (and while I love it when Jane Rady tells me that – she says 3x the phaco/MIGS market), the reality is that is comparing prevalence (3-4 MM pool now) to incidence (740K possible MIGS phacos per year).
- Surgical decision making.. each MIGS has their often set of characteristics — namely potency, risk, and ease of use — that will determine where they will fit in the glaucoma treatment paradigm
- Now vs 5-years MIGS allows us to intervene early safely. Combo with phaco