Forsight Vision5

© ForSight VISION5 2015 1

OIS@ASCRSApril 16, 2015

John Maroney, CEO


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


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


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


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.


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.


Clinical Results


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.


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



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



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 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


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


Unique Value

HUGE UNMET NEED in One of Largest

Ophthalmic Markets

COMPELLING RESPONSE in Clinical Feasibility

FIRST-IN-CLASS Product Profile

Drug Component has ESTABLISHED

EFFICACY

Platform for SEVERAL MAJOR Ophthalmic

MARKETS

Healthcare

Forsight Vision5