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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
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
2
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
3
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
Human Clinical Studies in Progress:
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
4
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
5
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
6
washout or
Treatment-naïve
Baseline 1 2 3 4 5
Months
US Phase IIb Early DR/ PVD (PACIFIC) Study
7
 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
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
8
9
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
Thank You
Confidential: Allegro Ophthalmics, LLC
10

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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 2
  • 3. Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved 3 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 4
  • 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 5
  • 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 6 washout or Treatment-naïve Baseline 1 2 3 4 5 Months
  • 7. US Phase IIb Early DR/ PVD (PACIFIC) Study 7  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 8
  • 9. 9 Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved Thank You