Presentation by Graybug Vision at OIS@ASRS 2016.
Participant:
Graybug Vision | Jeffrey Cleland, President & CEO
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2. 2
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potentially superiority to Eylea® and reduced injection frequency)
• On track for IND in 2017 for wet AMD indication (pre-IND completed)
Graybug Vision’s Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
• Injection with small gauge needle – no surgical procedure
• Minimal side-effects, no interference with visual axis
• Tunable approach – release rate and duration
• No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
• Age-related macular degeneration (wet & dry), glaucoma, neuroprotection, etc
• NCEs for glaucoma and neuroprotection for 6 month dosing regimen
• Potential for Product Specific Partnerships
Experienced and Knowledgeable Team
• Ophthalmology & Drug Delivery Experts
3. 3
GB-102 (Sunitinib):
Dual VEGFR/PDGFR tyrosine kinase inhibitor (TKI)
Sunitinib is the active ingredient in GB-102 and SUTENT®
• Oral dosing of SUTENT leads to higher ocular levels than GB-102 without ocular
toxicity
• Oral dosing of SUTENT is effective in mouse CNV model and a patient treated for
RCC with anti-VEGF refractory wet AMD (visual acuity improved)
• Oral doses of SUTENT required for ocular disease leads to systemic adverse events
GB-102 provides sustained intravitreal delivery minimizing systemic exposure
• A twice per year (or longer) dose interval may increase compliance and sustained
levels may increase durability of response
• Targeting VEGF & PDGF at the receptor level may increase response rates
• Opportunity for superiority compared to Eylea® (see Fovista® results) from a
single agent
GB-102 (Sunitinib) may become “Best in Class” Therapy to treat wet AMD
4. 4
Injectable High Capacity Reservoir and
Localization of Microparticles
Biodegradability
Biocompatibility
Bioabsorbability
Polymer
Modified to
Reduce
Inflammation
ENCAPSULATED DRUG INTRAVITREAL INJECTION
WITH SMALL GAUGE
NEEDLE
Microparticle
Localization
Designed to Aggregate
and Remain Outside
Visual Axis
FUNDUS PHOTOS, DAY 7
5. 5
Toxicokinetics & Safety after Single GB-102
IVT Injection in Pigmented Rabbits
10 mg GB-102 (1 mg sunitinib)
50 µL
Data Supports Twice Per Year Dosing
With Comparable Safety to Current Products
(Selected tissues)
6
Toxicokinetics Safety
• Single dose, 6 month non-GLP
study in rabbits
• Examination by slit-lamp &
histology at multiple time points
• No evidence of inflammation or
toxicity seen in any eyes treated
with GB-102 or placebo
microparticles
6. 6
Long Term Efficacy of GB-102 (Single Dose):
Potential for Superiority over Aflibercept
GB-102 is potentially better
than Eylea with a duration of
greater than 3 months
Lowest GB-102 dose is 1/20 Maximum
Feasible Dose (1 mg Sunitinib)
GB-102 Dose Groups
0.5 mg GB-102 (0.05 mg Sunitinib)
1 mg GB-102 (0.1 mg Sunitinib)
3 mg GB-102 (0.3 mg Sunitinib)
3 months
3 wk
3 wk
Aflibercept (Eylea®)
0.7 mg same day as laser
Fluorescein
Angiograms
(CNV area)
LaserDosing
GB-102 Dose 0.5 mg 1.0 mg 3 mg
Sunitinib Dose 0.05 mg 0.10 mg 0.30 mg Aflibercept Placebo
p < 0.01
Rabbit CNV
Model
Poster Presentation at AAO 2016
7. 7
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potential for superiority to Eylea® and reduced injection frequency)
• On track for IND in 2017 for wet AMD indication (pre-IND completed)
Graybug Vision’s Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
• Injection with small gauge needle – no surgical procedure
• Minimal side-effects, no interference with visual axis
• Tunable approach – release rate and duration
• No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
• Age-related macular degeneration (wet & dry), glaucoma, neuroprotection, etc
• NCEs for glaucoma and neuroprotection for 6 month dosing regimen
• Potential for Product Specific Partnerships
Experienced and Knowledgeable Team
• Ophthalmology & Drug Delivery Experts