forsight vision-5
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© ForSight VISION5 2014 1
Ophthalmology Innovation Summit 16 October 2014
© 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
© 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
© 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
© 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…?”
© 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%
© 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.
© 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
© 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
Elut
ion
Rate
(m
cg
/da
y)
Time (Days)
Low Duration Mid Duration High Duration
© 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
© 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
% S
ubje
cts
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
© 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
© 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
© 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)
© 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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