OIS@ASCRS
April 16, 2015
John Maroney, CEO
© ForSight VISION5 2015
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TM
Helios Ocular Insert is Designed to Improve Adherence
for IOP-Lowering Medication

Problem:
–
–

Our Goal:
–
–

~50% of Patients on PGAs Have Poor Adherence / Challenges Taking Drops
Inadequate Adherence  High/Variable IOP  Visual Field Loss
Clinically Relevant IOP-Lowering for 6 Months from a Single PhysicianAdministered, Non-Invasive Ocular Insert
Target NDA submission in 2018.
• Final Data Available from Phase 2 Study
• Phase 3 Program starts Q1-2016
Financing / Pipeline:
–
–
Raised $38.3MM to date from Well-Known VCs
Additional Product Candidates in Pipeline
© ForSight VISION5 2015
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VISION5 Target Market: Glaucoma / OHT Patients who
are Non-Adherent or Unable to Take Drops
Highly-Effective Treatments Exist


PGA Drops are Standard of Care
>2 Million Patients in USA Use PGAs
Yet <50% Use Them After
One Year1 and are at High
Risk for Vision Loss
Of Glaucoma Patients,
~60% Cannot Administer
Drops Properly2
1Nordstrom,
et al. “Persistence and Adherence with Topical Glaucoma Therapy.” Am J Ophthalmol 2005;140:598-606.
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
© ForSight VISION5 2015
The Helios Insert is limited by United States Law to Investigational Use.
2Hennessy
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Strong Market Demand for Product that Addresses
Compliance
Q: What Percentage of Your Patients Would Benefit from
Using the Ocular Insert?
Appear to be
Non-Compliant
Appear to be
Compliant
Similar Efficacy as
Timolol
69%
53%
Slightly Less
Similar Efficacy as
Efficacy than
Prostaglandin
Timolol
65%
52%
N=50 ophthalmologists and 50 optometrists
Conclusion:
• Simple, Safe & Effective Product would likely have Wide Market
Adoption
Source: Online survey conducted by Leerink in January 2015. Percentages are mean of answers for “Glaucoma patients” and
“OHT patients,” which were similar in all cases. Assumes product is applied every 6 months.
© ForSight VISION5 2015
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Goal: Provide More Consistent Care
1. Potential to Enhance Adherence to Follow up Visits: Cannot Get
Refills by Phone and Miss Appointments with Helios
 Patient must return to physician for new Insert and evidence
suggests that surveillance at appropriate intervals improves
patient outcomes
2. Sustained Release has Opportunity to Lower Mean IOP and
Reduce IOP Variability due to Intermittent or Poor Compliance
 Scenario: Two patients have mean medicated IOP of 19.5
mmHg at a given time point. Which patient would you prefer:
– Patient A: 19.5 mmHg* every day at that time or
– Patient B: 17 mmHg* when they are taking their
medication half of the time or 22 mmHg when they are
missing a dose at 50% of visits?
• Can Discuss scenario during Panel
*Scenario Criteria: Assumes unmedicated IOP of 24 mmHg. 19.5 mmHg (4.5 mmHg IOP reduction) = slightly less efficacy than timolol
with near-perfect adherence. 17 mmHg (7 mmHg IOP reduction) = PGA-like. 22 mmHg = somewhat washed out of medication /
inconsistent dosing.
© ForSight VISION5 2015
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Lead Product Candidate: ForSight HeliosTM Insert
IOP CONTROL

Continuous Release
of Bimatoprost

Ensures Compliance

Preservative Free
NON-INVASIVE


Simple, Topical InOffice Placement

Comfortable to Wear:


INTUITIVE & DURABLE
90-95% Patient
Acceptance*
High Retention Rates
for Insert

Goal: Eliminate Daily
Drops for Patients on
IOP-Lowering Drops
Replacement During
Existing, Established
Visit Schedule (~6
Months)
Source: *95% (37 of 39) of patients in Study 305 found Insert acceptably comfortable. 90% in FSV5-002 washout period.
The Helios Insert is limited by United States Law to Investigational Use.
© ForSight VISION5 2015
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Clinical Results
© ForSight VISION5 2015
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Phase 1b Pooled Studies 501/502 – Mid Dose
Sustained IOP-reduction for 3-months Observed (N=36 Subjects)
3-month duration with Mid Dose:
6.7 mmHg reduction
Source: Goldberg, I. et al, American Academy of Ophthalmology (2014)
•
Phase 1 High Dose (6 Month) Data Accepted for World Glaucoma Congress 2015
The Helios Insert is limited by United States Law to Investigational Use.
© ForSight VISION5 2015
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Summary: Phase 1 Results


Supports proof-of-concept that a single High Duration Insert can
provide sustained, clinically relevant IOP-lowering for up to 6 months
No unanticipated adverse events
– Most frequent AEs:
• Hyperemia appears similar to or better than daily PGA drops
• Mucus slightly elevated

Provided scientific rationale for primary Phase 2 study (FSV5-002)
evaluating the High Duration ocular insert
The Helios Insert is limited by United States Law to Investigational Use.
© ForSight VISION5 2015
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Phase 2 Study (FSV5-002)
Screening
N=169
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




Randomized
(1:1)
N=130
PGA
Insert
+
Artificial Tears
6 months
Placebo
Insert
+
0.5% Timolol
6 months
Demonstrated Sustained IOP-Lowering for 6 Months
93% of subjects: bilateral primary ocular insert retention through first 3 months
90% of subjects were comfortable wearing inserts prior to randomization
Most frequent AEs: Ocular Discharge and Hyperemia
No reported ocular SAEs in PGA Insert arm
Data Submitted for Peer Reviewed Presentation / Publication in 2015
The Helios Insert is limited by United States Law to Investigational Use.
© ForSight VISION5 2015
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Lead Product Candidate Development Pathway
2015
2014
2016
2017
2019
2018
Ph 2 Efficacy
LPO
Nov
Ph 2 Extension Study #1
Ph 2 Dose-Ranging
Ph 2 Extension Study #2
Ph 3 Program
NDA Filing
FDA review
The Helios Insert (Lead Product Candidate) is limited by United States Law to Investigational Use.
© ForSight VISION5 2015
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ForSight VISION5 is Actively Developing Products for
Three Major Indications

Completed Recruiting Dose-Ranging Study for Lead Product Candidate

Lead Product Candidate Expected to Start Phase 3 in early 2016

Programs also Active in Glaucoma (Fixed Combination), Dry Eye, Allergy
GLAUCOMA
DRY EYE
ALLERGY
2MM
Patients
5MM
Patients
300k
Patients
(USA)
(USA)
(USA)
© ForSight VISION5 2015
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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, Baxter, Calhoun Vision and Chiron Vision;
>50 US Patents
Charles Semba, M.D.
Chief Medical Officer. Shire, SARcode, Genentech, Stanford
Anne Rubin, MBA
Vice President, Marketing. ForSight VISION4, Corventis, Medtronic
Carlos Schuler, Ph.D.
Vice President, Technical Operations. S.E.A. Medical Systems, Incline
Therapeutics, Talima, Anesiva, Nektar Therapeutics; 10 US Patents
Judy Gordon, DVM
Lead Regulatory Advisor. Owner, ClinReg Consulting
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
Prof. Kuldev Singh
Prof. James Brandt
Eye Associates, Sydney, AUS; Phase 1 Principal Investigator
Stanford University
University of California, Davis; Phase 2 Principal Investigator
© ForSight VISION5 2015
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Unique Value
HUGE UNMET NEED in One of Largest
Ophthalmic Markets
Drug Component has ESTABLISHED
EFFICACY
FIRST-IN-CLASS Product Profile
COMPELLING RESPONSE in Clinical Feasibility
Platform for SEVERAL MAJOR Ophthalmic
MARKETS
© ForSight VISION5 2014
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