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Forsight Vision 5 company presentation from OIS@AAO 2015
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ForSight Vision-5
1.
Proprietary & Confidential
© ForSight VISION5 2015 Ophthalmology Innovation Summit @ AAO November 2015
2.
Proprietary © ForSight
VISION5 2015 2 The Helios InsertTM is limited by United States Law to Investigational Use Only. Non-Adherence: The Great Frontier of Ophthalmology 1Nordstrom, et al. AJO 2005;140:598-606.; 2Hennessy AL, et al. AJO. 2011 Dec;152(6):982-8 <50% of Patients Use Their Drops1 ~60% Cannot Administer Drops2 Durable Effect Non-invasive, Retained Simple, In-Office Placement Solution: V5 Sustained Release Ring Great Frontier $2B Market Everyone Loses: Patients, Physicians, Drop Providers
3.
Proprietary © ForSight
VISION5 2015 3 The Helios InsertTM is limited by United States Law to Investigational Use Only. Consistent Performance in Clinical Trials: Four Phase 1 (N=73) & Four Phase 2 (N=251) Topical, Comfortable (90%), Well-retained (90% at 6 months)1 Durable Efficacy One ring provides clinically significant IOP reduction for 6 months2 Safety & Benefits Uneventful safety profile Regulatory pathway: NDA in 2019 Patient Acceptance Market Value 85% of patients recommend insert3 80% of doctors prefer insert to drops4 Future Validated Platform for Fixed Combination Glaucoma, Allergy, Dry Eye, Other Pipeline 1FSV5-002, 2Goldberg et al. WGC 2015; 3Study 20150706; 4GLG Survey
4.
Proprietary © ForSight
VISION5 2015 4 The Helios InsertTM is limited by United States Law to Investigational Use Only. Patient Acceptance: Simple, Comfortable, Well-Retained Filmed at the Sall Research Medical Center; Artesia, CA 90% of Patients are Comfortable Wearing Non-medicated Ring1 90% of Patients Retain Inserts (OU) for 6 Months2 1Study 305, FSV5-002 & FSV5-004 (washout); 1FSV5-002
5.
Proprietary © ForSight
VISION5 2015 5 The Helios InsertTM is limited by United States Law to Investigational Use Only. Phase 1 Efficacy Results1 Mean Diurnal Intraocular Pressure (IOP) with Bimatoprost Insert (N = 27 subjects) Mean IOP reduction: 4.7 to 6.5 mmHg from washout 1Goldberg, I. et al. (2015, June). Poster presented at World Glaucoma Congress 2015. 5.1 mmHg
6.
Proprietary © ForSight
VISION5 2015 6 The Helios InsertTM is limited by United States Law to Investigational Use Only. Phase 2: Two Efficacy Studies with Open-Label Extension Studies Data will be presented by Dr. James Brandt on Tuesday @ 9:03 am (Venetian D) Bimatoprost Insert demonstrated clinically significant IOP-Lowering for 6 Months1 ~90% of subjects had unassisted retention of inserts through 6 months Safety was uneventful and consistent with earlier data Second Phase 2 Study FSV5-004: Dose-Ranging: Full Data in Q4:15 Screening N=169 Randomized (1:1) N=130 PGA Insert + Artificial Tears Placebo Insert + 0.5% Timolol 6 months 6 months First Phase 2 Study: FSV5-002 1Presentation abstract: mean diurnal IOP; available on AAO website
7.
Proprietary © ForSight
VISION5 2015 7 The Helios InsertTM is limited by United States Law to Investigational Use Only. Regulatory Pathway Identified Pathway Identified; NDA Filing In 2019 FDA Guidance On Approach Precedent For Products With Similar Efficacy-Safety Profile Regulatory Pathway Durable Efficacy Safety
8.
Proprietary © ForSight
VISION5 2015 8 The Helios InsertTM is limited by United States Law to Investigational Use Only. Voice of Customer: Patients Recommend Insert 1Study 20150706 (N=92) 55% 30% 11% 1% 1% 1% Strongly Agree Agree Neutral Disagree Strongly Disagree No Response • 85% of Our Patients Would Recommend Product to Friend or Family with Adherence Challenges1 85%
9.
Proprietary © ForSight
VISION5 2015 9 The Helios InsertTM is limited by United States Law to Investigational Use Only. Voice of Customer: Physicians Prefer Insert 1GLG Survey, Q45.; 2Leerink Survey, Q13; S2N Market Research Survey, M3 Market Research Data 83% 10% 8% Prefer Insert to Drops Insert ≈ Drops Prefer Drops to Insert >80% of Physicians Prefer Helios Product Profile to PGA Eye Drop1 When available, expect to use in >50% of Glaucoma Patients2
10.
Proprietary © ForSight
VISION5 2015 10 The Helios InsertTM is limited by United States Law to Investigational Use Only. Imagine a Future without Drops… Proprietary, Validated Platform Continues to Deliver Opportunity Life Cycle Management: Generic & Proprietary Compounds The Future is Here Today for Glaucoma Glaucoma Fixed-Combo Glaucoma Allergy Dry Eye
11.
Proprietary © ForSight
VISION5 2015 11 The Helios InsertTM is limited by United States Law to Investigational Use Only. Investment Highlights Innovative company developing non-invasive sustained therapy for major eye diseases First product candidate (HeliosTM Insert) expected to start Phase 3 in 2016. – Significant opportunity to address unmet adherence need in $6+ billion1 WW glaucoma market Ocular insert validated as delivery system: – Applications to dry eye, allergy, research collaborations Blue Chip Investors: 1Estimates from Allergan investor presentation, 30 Jun 2014.
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