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ForSight Vision5 presentation presented at OIS@AAO 2014
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ForSight Vision-5
1.
© ForSight VISION5
2014 1 Ophthalmology Innovation Summit 16 October 2014
2.
© ForSight VISION5
2014 2 n 5th Company Launched by ForSight Labs n VC Syndicate with Significant Ophthalmic Experience STRONG FOUNDATION Who We Are: ForSight VISION5 CLINICAL RESULTS n 70+ Patient Open- Label Efficacy Data n Excellent Patient Comfort & Retention n Phase 2 is Enrolled; Final Data in Q4:14 n Goal of Non- Invasive 3 to 6 Month Therapy = First in Class n Lead Product in Phase 2 n Robust Pipeline INNOVATION & EXECUTION MARKET NEED n Goal: Improve Ophthalmic Medication Adherence n Non-Invasive, Sustained Release Drug Delivery System
3.
© ForSight VISION5
2014 3 Initial Target Market Novel Non-Invasive Insert System to Deliver Sustained Therapy to the Ocular Surface Sources: 1Adapted from IMS data and Friedman et al. Invest Ophthalmol Vis Sci. 2007;48:5052– 5057. 2Adapted from: http://www.ncbi.nlm.nih.gov/pubmed/12888056 and http://www.ncbi.nlm.nih.gov/pubmed/19506195 3NPA, data from Q3: 2010 for Pataday, Patanol, Bepreve, Elestat, Optivar, and others as quoted by ISTA pharmaceuticals and Red Book data pricing for Pataday. 2MM Patients GLAUCOMA 1 § PGA has Demonstrated Efficacy § Long Duration (180 day target) 5MM Patients DRY EYE 2 300k Patients ALLERGY 3
4.
© ForSight VISION5
2014 4 VISION5 Target Market: Glaucoma / OHT Patients who are Non-Compliant or Unable to Take Drops 1NICE Guidelines: http://www.nice.org.uk/nicemedia/live/12145/43888/43888.pdf; Appendix F, p.246 2Calculated as follows: IMS data shows 14.25MM Rx’s in 2012 for PGAs in USA. Mean medication possession ratio = 0.64 (Friedman et al. (Invest Ophthalmol Vis Sci. 2007;48:5052–5057). ((14.25MM)/12 months)/0.64 Rx/Pt/Month= 1.9MM patients 3Nordstrom, et al. “Persistence and Adherence with Topical Glaucoma Therapy.” Am J Ophthalmol 2005;140:598-606. 4Hennessy AL, Katz J, Covert D, Kelly CA, Suan EP, Speicher MA, Sund NJ, Robin AL. A video study of drop instillation in both glaucoma and retina patients with visual impairment. Am J Ophthalmol. 2011 Dec;152(6):982-8 Highly-Effective Treatments Exist n Prostaglandin Drops Reduce the Likelihood of Progression by 34-42% / Year1 n 2 Million Patients in USA Use PGA as First Line Treatment2 n PGAs Approved by FDA in 1990s; Excellent Safety Profile n Of Glaucoma Patients, ~60% Cannot Administer Drops Properly4 Yet <50% Use Them After One Year3
5.
© ForSight VISION5
2014 5 16% 14% 17% 26% 1 or More Difficulties, 56% None, 44% Returns with Uncontrolled IOP Requires a Caregiver to Administer Eye Drops Frequently Runs Out of Eye Drops before Insurance Covers Refill Forgets to Regularly Administer Eye Drops Difficulties with Drop Administration Glaucoma Patients Experience Difficulty Taking Drops Source: Third party survey of 75 ophthalmologists, 2014. Data on file. n Non-Compliant Patients Present a Key Unmet Need and Sustained Release Addresses Treatment Burden Q: “What Percentage of Your Patients…?”
6.
© ForSight VISION5
2014 6 Strong Market Demand for Product that Solves Compliance Appear to be Non-Compliant Appear to be Compliant Similar Efficacy as Timolol 70% 46% Similar Efficacy as Latanoprost 72% 57% Q: “If this Product Reduced IOP Similar to (Timolol or Latanoprost), While Guaranteeing 100% Compliance, in What Percentage of Your Patients Would You Use It?” AAO 2012—ForSight VISION5 Market Research (N = 101), conducted by an independent 3rd party Conclusion: Simple, Effective Product would have Wide Market Adoption Appear to be Non-Compliant Similar Efficacy as Timolol 70% Similar Efficacy as Latanoprost 72%
7.
© ForSight VISION5
2014 7 ForSight HeliosTM Insert and Compliant Dosing IOP CONTROL n Continuous Control of Intraocular Pressure (IOP) n Highly Effective PGA, (Approved Eye Drop) n Addresses Compliance n Preservative Free INTUITIVE & DURABLE n Designed to Eliminate Daily Drops n Reapplication During Existing, Established Visit Schedule for Patients NON-INVASIVE n Simple Application by Eye Care Professional on Ocular Surface n Comfortable to Wear – 90-95% Patient Acceptance* n High Product Retention Rates Source: *95% (37 of 39) of patients in Study 305 found Insert acceptably comfortable.
8.
© ForSight VISION5
2014 8 Insert Slowly Releases Medication for Months n Drug Release is Gradual, Controlled, and Predictable n PGA Diffuses through Polymer and Releases into Tear Film n PGA in Tear Film Diffuses through Cornea and Sclera to Effect IOP Day 1: Drug close to surface is released; other drug diffuses closer to surface Diffusion-Mediated Drug Release from Polymer: Day 180: Drug-depleted zones of matrix are present 6 months
9.
© ForSight VISION5
2014 9 Phase 1 Dose-Finding Informed Phase 2 Dose Selection Product Configuration Clinical Locales # of Subjects Low Duration ANZ 15 Mid-Duration ANZ/EU 43 High Duration (V501P) ANZ/EU US Phase II US Extension Study 31 (open-label) ~65 (High Duration Arm) 50+ Mid Duration Efficacy Data to be Presented on Monday at AAO by Prof. Ivan Goldberg (Poster PO390) 0 30 60 90 120 150 180 ElutionRate(mcg/day) Time (Days) Low Duration Mid Duration High Duration
10.
© ForSight VISION5
2014 10 USA Patients find Product Comfortable n Insert was Tested in 39 Patients at 3 Clinical Sites for 2 Months in USA* – Insert Did Not Contain Drug – Tested for Fitting and Comfort n Results: – 37 of 39 Patients (95%) Completed Full Two- Month Study *ForSight VISION5 Clinical Study 305 Completed 2 Month Study 95%, (n = 37) Withdrew Early (Discomfort) 5%, (n = 2) Study Provided Confidence to Start Phase 2 Study in USA
11.
© ForSight VISION5
2014 11 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Washout Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 %Subjects Study Month % of Patients Retaining Inserts in Month Insert Retention in Phase 2 Study is Very High 94% in washout month (learning period) Data as of 19 August 2014; data pooled from both arms of study. N=130 Subjects Randomized. Study in Follow-Up. 98% per month observed on treatment
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© ForSight VISION5
2014 12 Phase 2 Study Design: Randomized Controlled Trial n Primary Endpoint through 3 months; Patients will be followed through 6 months (secondary endpoints) on same inserts n Final Data Expected Q4:14
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© ForSight VISION5
2014 13 ForSight VISION5 is Actively Developing Products for Three Major Indications n Lead Product (PGA) Expected to Start Phase 3 Studies in 2015 n Programs also Active in Dry Eye and Allergy – Stay Tuned! 2MM Patients GLAUCOMA 5MM Patients DRY EYE 300k Patients ALLERGY
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© ForSight VISION5
2014 14 Team of Leaders and Experts ForSight VISION5 Team John Maroney Chief Executive Officer; Delphi Ventures, EndoTex, Boston Scientific; CVIS, Abbott Labs, Oximetrix Cary Reich, Ph.D. Chief Technology Officer; Inamed, Calhoun Vision and Chiron Vision; 25 US Patents Charles Semba, M.D. Chief Medical Officer. SARcode (acquired by Shire), Genentech, Stanford Carlos Schuler, Ph.D. Vice President, Technical Operations. S.E.A. Medical Systems, Incline Therapeutics, Talima, Anesiva, Nektar Therapeutics; 10 US Patents Anne Rubin, MBA Vice President, Marketing. ForSight VISION4, Corventis, Medtronic Judy Gordon, DVM Lead Regulatory Advisor. Owner, ClinReg Consulting Tim Kahlenberg, MBA Acting CFO. Medtronic, Ardian, Xtent, LuMend, AneuRx, DVI Co-Founders Prof. Eugene de Juan, Jr., M.D. ForSight Labs Founder, Distinguished Chair at UCSF, Professor of Ophthalmology at Duke, Johns Hopkins and USC; over 200 publications K. Angela Macfarlane, J.D. CEO, ForSight Labs and ForSight VISION4, The Foundry, TransVascular, AneuRx, VidaMed Medical Advisors / Principal Investigators Prof. Ivan Goldberg (Eye Associates, Sydney, AUS) (Phase 1 Principal Investigator) Prof. Kuldev Singh (Stanford University) Prof. James Brandt (University of California, Davis) (Phase 2 Principal Investigator)
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© ForSight VISION5
2014 15 Unique Value HUGE UNMET NEED in One of Largest Ophthalmic Markets COMPELLING RESPONSE in Clinical Feasibility FIRST-IN-CLASS Product Profile Drug has ESTABLISHED EFFICACY First of THREE MAJOR Anterior Segment MARKETS
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