Luminate is a first-in-class anti-integrin product in late stage development for the treatment of retinal diseases like diabetic macular edema (DME) and proliferative vitreoretinopathy (PVD). It works through novel mechanisms of action for anti-angiogenesis and vitreolysis. Phase 2b clinical trial data for DME and PVD are expected to be available in Q1 2017. Luminate has been administered to over 400 subjects safely and could offer increased durability, better safety, and new treatment options compared to existing anti-VEGF drugs.
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics
1. Luminate® for the
Treatment of Retinal Diseases
Ophthalmology Innovation Summit
August 8, 2016
Vicken Karageozian, MD
President
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
2. Luminate® - What does Allegro Offer?
First in class anti-integrin product (Luminate®) with
novel MOA for anti-angiogenesis and vitreolysis
Late stage development with multiple programs in
phase 2b or later
DME phase 2b DEL MAR (mono, combo, treat and maintain therapy)
data lock Q1 2017
PVD phase 2b PACIFIC data lock Q1 2017
VMT phase 3 ready
~ 400 human subjects treated with well-tolerated
safety
Non-clinical aspects of program de-risked
Composition of matter IP, solid PK, Tox, and CMC packages
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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3. Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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Anti-Angiogenesis
Benefits
Increased durability
Better safety
New MOA with new
treatment options
Benefits
Vitreolysis and PVD
induction
Better safety
New MOA with new
treatment options
DME Wet AMD PVD
Vitreolysis
VMT
4. Human Clinical Studies in Progress:
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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5. US Phase IIb DME (DEL MAR) Study
Stage 1 – 6 months, 148 subjects completed enrollment
3 monthly loading injections
Efficacy endpoints mean change in BCVA and OCT
CRT at Weeks 16 & 20
1.0, 2.0, and 3.0 mg Luminate compared to Avastin
Final readout Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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6. US Phase IIb DME (DEL MAR) Study
Stage 2 – 5 months, 75 subjects targeted
3 monthly loading injections
Testing additional treatment schemes:
Adjunct therapy (baseline anti-VEGF then Luminate
monotherapy) added
Combination therapy with Avastin added
Final readout Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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washout or
Treatment-naïve
Baseline 1 2 3 4 5
Months
7. US Phase IIb Early DR/ PVD (PACIFIC) Study
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100 subjects with NPDR without PVD
Up to 3 intravitreal monthly injections - 1.0, 2.0, 3.0, 4.0 mg
Luminate vs BSS
New indication with novel endpoint - PVD induction based on
B-scan and/or OCT
Duke reading center for endpoint grading
Study completion targeted for Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
washout or
treatment naïve
Baseline 1 2 3 4 5
Months
8. Moving Forward With Luminate®
Differentiated mechanisms of action
with unique benefits
Anti-integrin vs. anti-VEGF platform
Increased durability in anti-
angiogenesis
New treatment options
Evaluating mono-therapy, combo
therapy, and treat/maintain therapy
Better safety profile ~400 subjects
treated
In multiple Phase 2 US studies in
DME & PVD
All Phase 2 studies readout in next 6-
9 months
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
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