Post on 13-Apr-2017
© ForSight VISION5 2015 2
HeliosTM
Ocular Insert is Designed to Improve Adherence for IOP-Lowering Medication
Problem:
– ~50% of Patients on PGAs Have Poor Adherence / Challenges Taking Drops
– Inadequate Adherence High/Variable IOP Visual Field Loss
Our Goal:
– Clinically Relevant IOP-Lowering for 6 Months from a Single Physician-Administered, 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 3
VISION5 Target Market: Glaucoma / OHT Patients who are Non-Adherent or Unable to Take Drops
1Nordstrom, et al. “Persistence and Adherence with Topical Glaucoma Therapy.” Am J Ophthalmol 2005;140:598-606.2Hennessy 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):982-8The Helios Insert is limited by United States Law to Investigational Use.
Highly-Effective Treatments Exist
PGA Drops are Standard of Care >2 Million Patients in USA Use PGAs
Of Glaucoma Patients, ~60% Cannot Administer Drops Properly2
Yet <50% Use Them After One Year1 and are at High Risk for Vision Loss
© ForSight VISION5 2015 4
Strong Market Demand for Product that Addresses Compliance
Appear to be
Non-Compliant
Appear to be
Compliant
Similar Efficacy as
Timolol69% 53%
Similar Efficacy as
Prostaglandin65% 52%
Q: What Percentage of Your Patients Would Benefit from
Using the Ocular Insert?
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.
Conclusion:
• Simple, Safe & Effective Product would likely have Wide Market
Adoption
Appear to be
Non-Compliant
Similar Efficacy as
Timolol69%
Slightly Less
Efficacy than
Timolol65%
N=50 ophthalmologists and 50 optometrists
© ForSight VISION5 2015 5
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 andReduce 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 6
Lead Product Candidate: ForSight HeliosTM Insert
IOP CONTROL
Continuous Release of Bimatoprost
Ensures Compliance
Preservative Free
INTUITIVE & DURABLE
Goal: Eliminate Daily Drops for Patients on IOP-Lowering Drops
Replacement During Existing, Established Visit Schedule (~6 Months)
NON-INVASIVE
Simple, Topical In-Office Placement
Comfortable to Wear:
90-95% Patient Acceptance*
High Retention Rates for Insert
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 8
Phase 1b Pooled Studies 501/502 – Mid DoseSustained IOP-reduction for 3-months Observed (N=36 Subjects)
Source: Goldberg, I. et al, American Academy of Ophthalmology (2014)
3-month duration with Mid Dose:
6.7 mmHg reduction
• 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 9
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 10
Phase 2 Study (FSV5-002)
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
Screening
N=169
Randomized
(1:1)
N=130
PGA
Insert
+
Artificial Tears
Placebo
Insert
+
0.5% Timolol
6 months
6 months
The Helios Insert is limited by United States Law to Investigational Use.
© ForSight VISION5 2015 11
Lead Product Candidate Development Pathway
Ph 2 EfficacyLPONov
Ph 2 Extension Study #1
Ph 2 Dose-Ranging
Ph 2 Extension Study #2
Ph 3 ProgramFDA review
NDA Filing
2015 2016 2017 20182014
The Helios Insert (Lead Product Candidate) is limited by United States Law to Investigational Use.
2019
© ForSight VISION5 2015 12
ForSight VISION5 is Actively Developing Products forThree 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
2MM
Patients(USA)
GLAUCOMA
5MM
Patients(USA)
DRY EYE
300kPatients
(USA)
ALLERGY
© ForSight VISION5 2015 13
Team of Leaders and Experts
ForSight VISION5 Team
John MaroneyChief 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 Eye Associates, Sydney, AUS; Phase 1 Principal Investigator
Prof. Kuldev Singh Stanford University
Prof. James Brandt University of California, Davis; Phase 2 Principal Investigator