emerging approaches to combination therapies in amd & dme - allegro ophthalmics

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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

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Page 1: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

Luminate® for the Treatment of Retinal Diseases

Ophthalmology Innovation SummitAugust 8, 2016

Vicken Karageozian, MDPresident

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved

Page 2: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

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-riskedComposition of matter IP, solid PK, Tox, and CMC packages

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved2

Page 3: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved3

Anti-Angiogenesis

Benefits

Increased durability Better safetyNew MOA with new treatment options

Benefits

Vitreolysis and PVD inductionBetter safetyNew MOA with new treatment options

DME Wet AMD PVD

Vitreolysis

VMT

Page 4: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

Human Clinical Studies in Progress:

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved4

Page 5: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

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

Page 6: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

US Phase IIb DME (DEL MAR) Study

Stage 2 – 5 months, 75 subjects targeted3 monthly loading injectionsTesting additional treatment schemes:

Adjunct therapy (baseline anti-VEGF then Luminate monotherapy) added

Combination therapy with Avastin addedFinal readout Q1 2017

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved 6

washout or Treatment-naïve

Baseline 1 2 3 4 5Months

Page 7: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

US Phase IIb Early DR/ PVD (PACIFIC) Study

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100 subjects with NPDR without PVDUp to 3 intravitreal monthly injections - 1.0, 2.0, 3.0, 4.0 mg

Luminate vs BSSNew indication with novel endpoint - PVD induction based on

B-scan and/or OCTDuke reading center for endpoint gradingStudy completion targeted for Q1 2017

Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved

washout or treatment naïve

Baseline 1 2 3 4 5Months

Page 8: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

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 Reserved8

Page 9: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

9Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved

Thank You

Page 10: EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro Ophthalmics

Confidential: Allegro Ophthalmics, LLC10