Russ Trenary President & CEO.

Transcription

1 Russ Trenary President & CEO

2 InnFocus Goals! Provide a safe, effective and easy treatment for early-stage to latestage POAG patients!! First randomized controlled study against trabeculectomy, the gold standard!! Implant over 150 patients by over 20 doctors in 6 countries, followed for up to 3 years, by early 2015.!! Leverage the technology to treat Normal Tension and Closed Angle Glaucoma.!! Covers all major glaucomas in all countries!! Conclude C Round in early 2015!! B round led by a $5 billion ophthalmic company 2

3 Global Glaucoma Market: 2 nd leading cause of blindness affecting 78.5 MM patients worldwide Other Glaucomas (WW) 8 MM (10%) Patients with Open-Angle Glaucoma 51.7 MM WW (66%) 3.5 MM in the U.S. Angle-Closure Glaucoma (WW) MM (24%) CAGR for glaucoma surgical devices estimated at 41% for the next 5- years, representing one of the largest growth opportunities in medical devices! Market Scope 2014: Comprehensive Report on the Global Glaucoma Surgical Device Market 3

4 InnFocus MicroShunt Benefits; Results, Material, Market Size, and Study Format and Labeling!! Proven in OUS trials; achieving mean post op IOP below 14 mm Hg, and 80% med reduction.!! Durable surgical results uniquely not temporary. IOP reduction at 3 months is similar to 3 year results.!! Revolutionary SIBS material is ultra-stable, won t degrade, with a 13-year proven history on drug eluting coronary stents (TAXUS); the eye doesn t know this material is in the eye, Dr. Paul Palmberg, MD, PhD.!! We address the largest patient segment by far - in a large and growing market. Glaucoma is the second leading cause of blindness affecting over 100 M eyes worldwide.!! Our US FDA trial is the only randomization against the gold standard trabeculectomy procedure. 4

5 InnFocus MicroShunt ; Procedural Benefits! Short and simple procedure.!! Uses the time-tested gold standard drainage pathway to achieve low IOP without a scleral flap!! Successful with or without cataract surgery!! Safe, with little required follow-up!! Repeatable in all quadrants 5

6 The InnFocus MicroShunt Made from SIBS 6

7 Implanting the InnFocus MicroShunt Conjunctiva Tenons 2.8 7

8 Implanting the InnFocus MicroShunt 2.8 8

9 Implanting the InnFocus MicroShunt 2.8 9

10 Implanting the InnFocus MicroShunt

11 Dominican Republic and France Baseline Characteristics Characteristics Both Groups Patients (n=) 59 Age -Years (mean ± sd) 62.8 ± 14.2 (Range 27-83) Ancestral Heritage 22 mixed*/37 Caucasian Mean Visual Field MD ± 12.4 db Phakic/Pseudophakic/Cataract 12/16/18 Baseline IOP (mmhg) (mean ± sd) 23.1 ± 5.2 (Range 18 38) Mean Visual Acuity (Snellen) 20/50 (LP-20/20) Glaucoma Diagnosis 59 POAG Glaucoma Meds/patient (mean ± sd) 2.8 ± 1.2 (1-5) *Afro-Caribbean, Hispanic, Arawak Indian, Caucasian, or combination. Courtesy Juan Batlle et al and Isabelle Riss 11

12 Dominican Republic and France Mean change in IOP with InnFocus MicroShunt Intraocular Pressure (mmhg) n=59 Baseline IOP = 23.1 ± 5.2 mmhg Average IOP = 11.6 ± 0.4 mmhg n=45 n=42 n=22 n=34 n=22 AGIS zone of no progression of vision loss Months Post-Op Courtesy Juan Batlle, Isabelle Riss, et al. 12

13 Dominican Republic and France: Change in IOP with time for the InnFocus MicroShunt with and without Cataract Surgery ):767)) )9567)) )9767)) )8567)) )8767)) )567)) C3<$"ID#,%)J.",&) L)M);8) C3<$"ID#,%)K3%D)!+%+$+<%)I#$A&$() L)M)8N) )4)) 767)) 567)) 8767)) 8567)) 9767)) 9567)) :767)) :567)) ;767)) C",%D')="'%4EF&$+GH&)!"#$%&'()*#+,)-+%..&)!"#$%)+,/)0'+1&..&)23''## 13

14 Qualified Success Rate, Change in IOP, and Percent of Patients! 18 and 14 mmhg over the 3 Years Studied *Qualified success = (< 21mm Hg result, > 20% decline in IOP, and reduced meds usage) Time N Qualified Success (%)* IOP mmhg Mean Drop in IOP (%) % Patients w/iop! 18 mmhg % patients w/iop! 14 mmhg Pre-Op 59 N/A 23.1±5.2 N/A N/A N/A Yr % 11.4±3.1 51% 100% 85% Yr % 11.9±3.7 49% 91% 82% Yr % 10.7±3.5 54% 100% 82% 14

15 Change in Glaucoma Medication and Patients off Glaucoma Medication with Time Time N Glaucoma Meds/Patient Reduction in Med use from baseline (%) Patients off Meds (%) Pre-Op ± 1.2 N/A 0% Yr ± % 82% Yr ± % 86% Yr ± % 73% 15

16 Adverse Events!! IOP < 5 mmhg after day 1 = 10% All resolved spontaneously!! Choroidal Effusion = 5% All resolved spontaneously!! No Long-term sight threatening adverse events No endophthalmitis, chronic hypotony No progression of cataract in phakic patients 16

17 Conclusions from Studies in Dominican Republic and France; Data to 3 Years!! IOP reduction over 50% from baseline (on full meds) to under 14 mmhg!! More than 80% of eyes with IOP! 14 mmhg!! 84% reduction in glaucoma meds to 0.5 med/ patient!! Over 70% of patients entirely off eye drops at 3 years!! No long-term sight-threatening adverse events 17

18 The US IDE Study Design!! THE ONLY prospective, randomized controlled clinical study!! MicroShunt with MMC versus Trabeculectomy with MMC!! Major Inclusion Criteria:!! Trabeculectomy-stage patients uncontrolled by medication!! Phakic and pseudophakic (no combined cataract cases)!! Two Phases with two year follow-up!! Phase 1 (safety) 75 patients, in progress!! Phase II (safety and effectiveness) Begin early 2015, 412 patients. 18

19 US Clinical Trial Physicians Medical Monitor Paul Palmberg, MD, Ph.D. Bascom Palmer Eye Institute, Miami, FL Data Safety Monitoring Board David Musch, PhD U Michigan, Ann Arbor, MI Dale Heuer, MD Medical College of Wisconsin, Milwaukee, WI Wallace L. Alward, MD Univ. of Iowa, Iowa City, IA North American Investigators Steven Vold, MD Vold Vision, Fayetteville, AR Rob Feldman, MD Robert Cizik Eye Clinic, Houston, TX Adam Reynolds, MD Inter-Mountain Eye, Boise, ID Mahmoud Khaimi, MD Dean McGee Eye Institute, Oklahoma City, OK Michael Stiles, MD Stiles Eyecare, Overland Park, KS Lou Cantor, MD Glick Eye Institute, Indianapolis, IN Howard Barnebey, MD Specialty Eye Care, Bellevue, WA Robert Noecker, MD Ophthalmic Consultants of CT, Fairfield, CT Richard Lehrer, MD Ohio Eye Alliance, Alliance, OH Ken Schwartz, MD Washington Eye, Chevy Chase, MD Ron Fellman, MD Glaucoma Associates of Texas, Dallas, TX Chris Cruz, MD Baptist Hospital, Miami, FL 19

20 Americas Medical Advisory Board and Other Consultants North American Medical Advisory Board! Ike Ahmed, MD University of Toronto! Brad Shingleton, MD OCB Boston, MA! Steven Vold, MD Fayetteville, AR! Richard Parrish, MD Bascom Palmer, Univ. of Miami! Steven Sarkisian, MD Dean McGee, Univ. of Oklahoma! Howard Barnebey, MD Bellevue, WA! Kuldev Singh, MD Stanford University Advisors, and Consultants! Jean-Marie Parel, Ph.D., Bascom Palmer, Miami, FL! Eliot Lazar, MD, ElCon Medical (Buffalo, NY) 20

21 Thank you and please provide questions