Ivantis
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Ivantis is developing the Hydrus Microstent, a minimally invasive implant designed to dilate and scaffold the natural outflow path of the eye to treat glaucoma. It has raised $107 million and conducted clinical trials involving over 2,000 patients in 21 countries. A recent randomized controlled trial found that 74% of patients who received the Hydrus Microstent in addition to cataract surgery experienced at least a 20% reduction in eye pressure without medication, compared to 46% for cataract surgery alone, demonstrating the Hydrus' increasing treatment effect over time. Ivantis is pursuing US FDA approval for the Hydrus Microstent based on these promising clinical results.
Ivantis
- 1. Ivantis Overview David Van Meter OIS @ ASCRS April 16, 2015 Investigational Device Only in US 1
- 2. Ivantis Overview • Founded 2007 by top coronary stent inventors • Developing a minimally invasive microstent for glaucoma that dilates and scaffolds the natural outflow path of the eye • 27 FTE’s; based in Irvine, CA • $107 MM raised to date ($71 MM B round closed last year) • Global investor syndicate lead by NEA and Delphi • Over 2,000 patients treated globally • 21 countries and 75 surgeons • All patients either in Level One RCT’s or Global “Real World” Registry • Just completed recruitment in 558 subject US pivotal trial Investigational Device Only in US 2
- 3. The Hydrus™ Microstent Flexible, biocompatible Schlemm’s canal “scaffold” Scalloped and open design allows aqueous flow 3 clock-hour length targets multiple collector channels ** Investigational Device Only in USA 3
- 4. Hydrus Surgical Video Investigational Device Only in US 4
- 5. Commitment to Basic Science 5 Toris, Samuelson, Ahmed et al Outflow IOVS 2013:54:1698-1704 Grierson, Kahook, et al 3 month Monkey Biocompatibility Study J Glaucoma Nov 2013 ePub ahead of printGong, Johnstone, et al. Fluorescent Dye Intensity Study (AGS Paper 2013) Johnstone, Samuelson, et al Collector Channel Preservation Study Experimental Eye Research 2014;119:70-76 Investigational Device Only in US
- 6. Investigational Device Only in US 6 HYDRUS II Study A Prospective, Multicenter, Controlled, Randomized Trial Comparing Hydrus + Cataract to Cataract Alone In Press: Ophthalmology Top 10 Paper: AGS 2015
- 7. HYDRUS II: Level One Clinical Evidence • Trial was designed to closely simulate US pivotal trial – Utilizes the “state of the art” study design standards utilized in current FDA MIGS trials – Medications removed (“washout”) prior to surgery and 1 and 2 year follow-ups to remove confounding effect of medications on IOP • 7 top EU academic centers (Norbert Pfeiffer, PI) • 100 eyes with mild to moderate OAG undergoing cataract surgery • 1:1 randomization day of surgery • Average patient entered study at IOP of 19 on 2 meds; washout IOP was 26.5 77Investigational Device Only in US
- 8. HYDRUS II: Results 100.0% 84.0% 83.7% 77.1% 83.3% 72.9% 47.9% 46.9% 50.0% 37.8% 0% 20% 40% 60% 80% 100% Baseline 1M 6M 12M 18M 24M %ofPatients Medication Free Patients Hydrus+CS CS 3 of 4 of Hydrus patients vs. 1 of 3 cataract surgery remain medication free at 2 years P=0.0008 Investigational Device Only in US 8
- 9. T R E AT M E N T R E S P O N S E Investigational Device Only in US 9 88% 80% 74% 46% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 12 Months 24 Months HYDRUS II: 20% Drop in Washed Out Diurnal IOP Hydrus Control Analysis conducted on intention-to-treat basis. (N=50) (N=50) (N=50) (N=50) = 34% P = 0.0008 Hydrus increases response by 74% compared to cataract surgery alone HYDRUS II: Results
- 10. Ivantis Summary • Strong pre-clinical foundation through extensive basic science • Emphasis on Level One Clinical Evidence (multi center RCT’s) • Demonstrating an increasing effect over time relative to control group in Level One Clinical Trial • Global clinical experience in wide array of indications (not just mild glaucoma with cataract) • Well funded and now pursuing US FDA approval Investigational Device Only in US 10