Luminate® for the
Treatment of Retinal Diseases
Ophthalmology Innovation Summit
November 12, 2015
Vicken Karageozian, MD
Chief Technical Officer
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Allegro Ophthalmics: Integrin Peptide
Therapy for Vitreo-Retinal Eye Diseases
2
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
 Mid-stage biotechnology company
 In multiple Phase 2b US Studies in DME &
PVD
 Phase 2b VMT – met primary endpoint
 Differentiated mechanisms of action with
unique benefits
 Anti-integrin vs. anti-VEGF
 3+ months durability in DME and wAMD
 Robust vitreolysis
 Strong safety and efficacy profile with
>400 human injections to date
 Collaboration with strategic partners
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
• 1st in class anti-integrin peptide
• Potency comparable to anti-VEGF in mono-therapy
• 3+ months durability off-treatment
• Robust vitreolysis with an excellent safety profile
Anti-angiogenesis Vitreolysis
DME
US Phase 2b
Data Q3 16
Wet AMD
US Phase 2
Start mid 2016
VMT
US Phase 2b
Met 1º Endpoint
PVD for NPDR
US Phase 2b
Data Q3 16
3
4
Vitreolysis
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Key Market Differentiators for Luminate®
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
5
Jetrea
Safety
Serious neurotoxicity
Retinal tears and
detachment
Very well-tolerated; no
significant safety issues
Efficacy
26% efficacy rate in phase
3 studies
65% efficacy rate in latest
phase 2 study
No competition in PVD
Vitreolysis: VMT and PVD
 At least 100 subjects in 4 arms with VMT with or without MH
 Double masked, placebo-controlled, randomized, multi-center study in the
US and Eastern Europe
 2.0, 2.5 and 3.2mg Luminate® vs BSS
 3-month study with evaluation after 1, 2 and 3 monthly injections
 Primary endpoint: resolution of VMT by OCT by end of study (day 90)
 Enrollment and endpoint determinations made by Duke Reading Center
Phase IIb VMT Study: Design
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
6
45 day washout or
treatment naïve
Baseline 1 2 3
Months
Phase IIb VMT Study: Safety
 106 subjects enrolled from US and E. European sites
 Excellent Safety Profile:
 No study subjects in any of the three groups
experienced:
 Significant intraocular inflammation
 Cataract changes
 IOP changes
 Retinal tears
 Retinal detachments
 Neurotoxicity - afferent pupillary defects
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
7
Phase IIb VMT Study: Topline Efficacy
8Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Baseline Day 90
Phase IIb VMT Study: Statistical Analysis
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
• Phase 2 study met its primary endpoint with 65%
efficacy rate of VMT release vs 10% for BSS control
• 3.2mg Luminate® vs BSS
• This result was statistically significant at a 95%
confidence level at p=0.0129
• Data suggests pathway to phase 3
• Data confirms Luminate® robust vitreolytic activity
in human subjects
9
US Phase IIb PVD (PACIFIC) Study
10
 100 subjects with non-proliferative DR without PVD
 Up to 3 intravitreal monthly injections - 1.0, 2.0, and 3.0 mg
Luminate vs BSS
 PVD induction in diabetics closely associated with protection
against PDR progression
 New indication with novel endpoint
 Duke reading center for endpoint grading
 First patient enrolled 09/15
 Top line data Q3 2016
90 day washout
Baseline 1 2 3
Months
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
11
Anti-angiogenesis
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Key Market Differentiators for Luminate®
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
12
Avastin
Lucentis
Eylea
Frequency of
injections
Injections every
4-8 weeks
Injections every
12 weeks
Target patient
population
40-50% of current disease
population (all 3 drugs in
anti-VEGF)
Expanded treatment
population (new MOA)
Anti-angiogenesis: DME & Wet AMD
• End-stage patients,
many not responding
to anti-VEGF
• Mean peak BCVA
improvement: 10 letters
(or ~2 lines) 3 months
off-treatment
• 8 patients improved
3+ lines
• Improvements held 3+
months off-treatment
• Corresponding
improvement of BCVA
and CMT
• No patients lost vision
Phase Ib/IIa DME Study: BCVA in All Subjects
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
13
9.7
9.3
11.0 11.0 9.1
0
4
8
12
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
0.0
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Improvement in BCVA (ETDRS
letters converted from Snellen)
• Mean peak
improvement in
OCT CMT: 31%
for all subjects
• Improvement
held until Day 150
(3 months off-
treatment)
• Improvements
ranged from 20-
80% reduction in
CMT
Phase Ib/IIa DME Study: OCT CMT in All Subjects
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
14
461
439
390 359
387
350
450
550
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
519
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Central Macular Thickness
(microns)
US Phase IIb DME (DEL MAR) Study
 DME study comparing 1.0, 2.0, and 3.0 mg Luminate to
Avastin for extended durability
 Modeled after phase 1 POC DME study that showed 3+
months durability in monotherapy
 105 of 135 subjects enrolled thus far
 Efficacy endpoints focused on:
 BCVA and OCT central subfield thickness
 Increased durability: efficacy 3 or 4 months off tx in monotherapy
vs Avastin
 Study completion targeted for Q3 2016
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
15
Moving Forward With Luminate®
 Differentiated mechanisms of action with
unique benefits
 Anti-integrin vs. anti-VEGF platform
 Increased durability in anti-angiogenesis
 Robust vitreolysis
 Strong safety profile with >400 human
injections
 Top line data in Phase 2b VMT, met primary
endpoint
 In multiple Phase 2b US Studies in DME &
PVD ongoing
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
16
17
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Thank You

Allegro

  • 1.
    Luminate® for the Treatmentof Retinal Diseases Ophthalmology Innovation Summit November 12, 2015 Vicken Karageozian, MD Chief Technical Officer Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
  • 2.
    Allegro Ophthalmics: IntegrinPeptide Therapy for Vitreo-Retinal Eye Diseases 2 Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved  Mid-stage biotechnology company  In multiple Phase 2b US Studies in DME & PVD  Phase 2b VMT – met primary endpoint  Differentiated mechanisms of action with unique benefits  Anti-integrin vs. anti-VEGF  3+ months durability in DME and wAMD  Robust vitreolysis  Strong safety and efficacy profile with >400 human injections to date  Collaboration with strategic partners
  • 3.
    Copyright 2015 byAllegro Ophthalmics, LLC, All Rights Reserved • 1st in class anti-integrin peptide • Potency comparable to anti-VEGF in mono-therapy • 3+ months durability off-treatment • Robust vitreolysis with an excellent safety profile Anti-angiogenesis Vitreolysis DME US Phase 2b Data Q3 16 Wet AMD US Phase 2 Start mid 2016 VMT US Phase 2b Met 1º Endpoint PVD for NPDR US Phase 2b Data Q3 16 3
  • 4.
    4 Vitreolysis Copyright 2015 byAllegro Ophthalmics, LLC, All Rights Reserved
  • 5.
    Key Market Differentiatorsfor Luminate® Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 5 Jetrea Safety Serious neurotoxicity Retinal tears and detachment Very well-tolerated; no significant safety issues Efficacy 26% efficacy rate in phase 3 studies 65% efficacy rate in latest phase 2 study No competition in PVD Vitreolysis: VMT and PVD
  • 6.
     At least100 subjects in 4 arms with VMT with or without MH  Double masked, placebo-controlled, randomized, multi-center study in the US and Eastern Europe  2.0, 2.5 and 3.2mg Luminate® vs BSS  3-month study with evaluation after 1, 2 and 3 monthly injections  Primary endpoint: resolution of VMT by OCT by end of study (day 90)  Enrollment and endpoint determinations made by Duke Reading Center Phase IIb VMT Study: Design Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 6 45 day washout or treatment naïve Baseline 1 2 3 Months
  • 7.
    Phase IIb VMTStudy: Safety  106 subjects enrolled from US and E. European sites  Excellent Safety Profile:  No study subjects in any of the three groups experienced:  Significant intraocular inflammation  Cataract changes  IOP changes  Retinal tears  Retinal detachments  Neurotoxicity - afferent pupillary defects Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 7
  • 8.
    Phase IIb VMTStudy: Topline Efficacy 8Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved Baseline Day 90
  • 9.
    Phase IIb VMTStudy: Statistical Analysis Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved • Phase 2 study met its primary endpoint with 65% efficacy rate of VMT release vs 10% for BSS control • 3.2mg Luminate® vs BSS • This result was statistically significant at a 95% confidence level at p=0.0129 • Data suggests pathway to phase 3 • Data confirms Luminate® robust vitreolytic activity in human subjects 9
  • 10.
    US Phase IIbPVD (PACIFIC) Study 10  100 subjects with non-proliferative DR without PVD  Up to 3 intravitreal monthly injections - 1.0, 2.0, and 3.0 mg Luminate vs BSS  PVD induction in diabetics closely associated with protection against PDR progression  New indication with novel endpoint  Duke reading center for endpoint grading  First patient enrolled 09/15  Top line data Q3 2016 90 day washout Baseline 1 2 3 Months Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
  • 11.
    11 Anti-angiogenesis Copyright 2015 byAllegro Ophthalmics, LLC, All Rights Reserved
  • 12.
    Key Market Differentiatorsfor Luminate® Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 12 Avastin Lucentis Eylea Frequency of injections Injections every 4-8 weeks Injections every 12 weeks Target patient population 40-50% of current disease population (all 3 drugs in anti-VEGF) Expanded treatment population (new MOA) Anti-angiogenesis: DME & Wet AMD
  • 13.
    • End-stage patients, manynot responding to anti-VEGF • Mean peak BCVA improvement: 10 letters (or ~2 lines) 3 months off-treatment • 8 patients improved 3+ lines • Improvements held 3+ months off-treatment • Corresponding improvement of BCVA and CMT • No patients lost vision Phase Ib/IIa DME Study: BCVA in All Subjects Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 13 9.7 9.3 11.0 11.0 9.1 0 4 8 12 0 Days 30 Days 60 Days 90 Days 120 Days 150 Days 0.0 N=15 30 Days Off Treatment 60 Days Off Treatment 90 Days Off Treatment Improvement in BCVA (ETDRS letters converted from Snellen)
  • 14.
    • Mean peak improvementin OCT CMT: 31% for all subjects • Improvement held until Day 150 (3 months off- treatment) • Improvements ranged from 20- 80% reduction in CMT Phase Ib/IIa DME Study: OCT CMT in All Subjects Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 14 461 439 390 359 387 350 450 550 0 Days 30 Days 60 Days 90 Days 120 Days 150 Days 519 N=15 30 Days Off Treatment 60 Days Off Treatment 90 Days Off Treatment Central Macular Thickness (microns)
  • 15.
    US Phase IIbDME (DEL MAR) Study  DME study comparing 1.0, 2.0, and 3.0 mg Luminate to Avastin for extended durability  Modeled after phase 1 POC DME study that showed 3+ months durability in monotherapy  105 of 135 subjects enrolled thus far  Efficacy endpoints focused on:  BCVA and OCT central subfield thickness  Increased durability: efficacy 3 or 4 months off tx in monotherapy vs Avastin  Study completion targeted for Q3 2016 Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 15
  • 16.
    Moving Forward WithLuminate®  Differentiated mechanisms of action with unique benefits  Anti-integrin vs. anti-VEGF platform  Increased durability in anti-angiogenesis  Robust vitreolysis  Strong safety profile with >400 human injections  Top line data in Phase 2b VMT, met primary endpoint  In multiple Phase 2b US Studies in DME & PVD ongoing Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved 16
  • 17.
    17 Copyright 2015 byAllegro Ophthalmics, LLC, All Rights Reserved Thank You