A Santen company InnFocus mission

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Presentation transcript:

A Santen company InnFocus mission Develop the first, FDA-approved, minimally invasive standalone procedure for the treatment of mild-, moderate-, and severe-stage open-angle glaucoma, that lowers and sustains intraocular pressure under 15 mmHg, and eliminates eye drop medications in most patients

InnFocus MicroShunt® differentiation The MicroShunt® is the first and only surgical device/procedure to provide treatment for mild-, moderate-, and severe-stage standalone POAG No requirement to remove the cataract (but this can be done) Standalone procedure allows treatment of the largest population of patients with POAG Clinical outcomes meet AGIS1 objective (IOP <15 mmHg) It is the only device undergoing FDA randomized clinical study vs trabeculectomy The intellectual property of the MicroShunt® is protected AGIS, Advanced Glaucoma Intervention Study; FDA, Food and Drug Administration; IOP, intraocular pressure; POAG, primary open-angle glaucoma 1. Ederer F et al. Control Clin Trials. 1994;15(4):299–325

Poly(styrene-block-isobutylene-block-styrene) The SIBS material Poly(styrene-block-isobutylene-block-styrene) “SIBS” There is current, real-world experience with SIBS SIBS has been used for over 15 years in >1 million patients as a cardiac-stent coating (TAXUS®)1 It has also been used as an investigational product for over 8 years in the eye2 SIBS is a stretchy biomaterial that will not provoke scar tissue formation in the eye3 SIBS has proven biocompatibility4 SIBS is an ultra-stable material and will not degrade in the body5 No degradation means no chronic inflammation and minimal scarring6 SIBS, poly(styrene-block-isobutylene-block-styrene) 1. Silber S et al. Circulation. 2009;120(15):1498–1504; 2. InnFocus data on file; 3. Acosta AC et al. Arch Ophthalmol. 2006;124(12):1742–1749; 4. Pinchuk L et al. Biomaterials 2008;29(4):448–460; 5. Strickler F et al. J Biomed Mater Res A. 2010;92(2):773–782; 6. Pinchuk L et al. J Biomed Mater Res A. 2017;105(1):211–221

MicroShunt® design Soft to conform to the curvature of the eye Lumen sufficiently large to allow cells to pass; yet, small and long enough to prevent hypotony1 Fin to prevent migration and leakage around the outside of the tube2 1. Arrieta EA et al. Ophthalmic Surg Lasers Imaging. 2011;42(4):338–345; 2. Batlle JF et al. J Glaucoma. 2016;25(2):e58–65

Benefits to the glaucoma surgeon Potential replacement product for trabeculectomy and tubes Advantage in safety and operating time Potential advantage in post-operative patient follow up compared with trabeculectomy A potential replacement for some laser procedures that only deliver temporary relief1 May reduce or remove the need for patients to administer multiple eye drops sooner compared with other procedures2 A procedure that may halt the progression of the patient towards blindness2,3 1. Lam D et al. Asia Pac J Ophthalmol (Phila). 2016;5(1):2–4; 2. Batlle JF et al. J Glaucoma. 2016;25(2):e58–65; 3. Ederer F et al. Control Clin Trials. 1994;15(4):299–325

Change in mean IOP over time IOP, intraocular pressure

Mean visual acuity over time Data from studies: INN003, INN004, INN007, INN009, and Toronto

Mean change in visual acuity from screening Visual acuity is restored back to baseline in 1 week Data from studies: INN003, INN004, INN007, INN009, and Toronto

Mean change in IOP over time by pre-operative IOP The MicroShunt® has shown efficacy in both high- and low-IOP eyes Data to 11/02/2016; data from studies: INN003, INN004, INN007, INN009, and Toronto close to limbus T-test indicates that only the IOP values at 24 months are significantly different in high- vs low-IOP eyes (P=0.03) Medication/patient is the same in both groups up to 3 years IOP, intraocular pressure

Mean change in IOP over time by Mitomycin C dose 35 0.2 mg/mL MMC 30 0.4 mg/mL MMC 25 169 126 20 IOP (mmHg) 15 88 63 57 23 130 71 68 129 63 146 26 83 10 145 98 77 162 93 168 126 114 5 N Day 0 Day 1 Day 7 Day 21 Day 30 Day 42 Mon 3 Mon 6 Mon 9 Year 1 Year 2 Medications/patient Higher MMC concentration results in lower IOP and fewer medications/patient (P <0.05 from Day 21 to Year 1) IOP, intraocular pressure; MMC, Mitomycin C

US glaucoma surgical market InnFocus have focused on the total glaucoma surgical market Competitors1 have mainly focused only on niche cataract with glaucoma (~10%) US potential procedure market was estimated to be 7 million USD in 20142 Projected >40% CAGR for glaucoma surgical procedures from 2015 to 20202 This represents the largest growth opportunity in ophthalmology InnFocus provides 5 times the market opportunity vs the competitors CAGR, compound annual growth rate; USD, United States dollars 1. Glaukos, Transcend, Ivantis; 2. Market Scope 2014

MicroShunt® competitive advantage Bio-inert material with real world use SIBS material is ultra-stable; no evidence of degradation1 >1 million in-patient device implants (TAXUS® Stent)2 Over 15 years in-human use – 8 years in eyes Dr. Paul Palmberg3 – “The eye doesn’t know this material is in the eye” Design shown to prevent chronic hypotony4,5 Outer diameter (350 µm), lumen diameter (70 µm), length (8.5 mm) SIBS, poly(styrene-block-isobutylene-block-styrene) 1. Strickler F et al. J Biomed Mater Res A. 2010;92(2):773–782; 2. Silber S et al. Circulation. 2009;120(15):1498–1504; 3. University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute, Miami, FL; 4. Arrieta EA et al. Ophthalmic Surg Lasers Imaging. 2011;42(4):338–345; 5. Batlle JF et al. J Glaucoma. 2016;25(2):e58–65

InnFocus MicroShunt® summary Standalone procedure allows access to largest patient population First and only surgical device/procedure to provide treatment for mild-, moderate-, and severe-stage standalone POAG Clinical data shows IOP lowering capabilities with acceptable safety and tolerability profile MicroShunt® is the only device undergoing FDA randomized clinical study vs trabeculectomy Unique patented material as a glaucoma product with long-term material biocompatibility FDA, Food and Drug Administration; IOP, intraocular pressure; POAG, primary open-angle glaucoma

Thank you