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Luminate Treatment for Retinal Diseases
1. Luminate® for the
Treatment of Retinal Eye Diseases
Ophthalmology Innovation Summit – October 2014
Vicken Karageozian, MD
Chief Technical Officer
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
2. Allegro Ophthalmics: Integrin Peptide Therapy
for Vitreo-Retinal Eye Diseases
ü Mid-stage biotechnology company
ü In multiple Phase 2 US Studies in DME &
VMT
ü First in class anti-integrin MoA to treat neo-
vascular eye diseases and induce
vitreolysis
ü Clearly defined clinical and regulatory
endpoints
ü Strong safety profile
ü Solid efficacy data in multiple indications
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 2
3. Allegro Ophthalmics: Integrin Peptide Therapy
for Vitreo-Retinal Eye Diseases
ü Differentiated from existing anti-VEGF therapy
— Unprecedented durability, benefits last
3-4 months off treatment
— Ability to treat anti-VEGF plateaued patients
ü Composition of matter patents pending
ü Commercial opportunities validated by third
party market research
ü Collaboration with strategic partners
ü Experienced management team
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 3
4. Luminate® Mechanisms of
Action & Indications
Anti-angiogenesis Vitreolysis
Diabetic
Macular Edema
Wet Age-Related
Macular Degeneration
Vitreomacular
Traction
PVD for Diabetic
Retinopathy
4.0MM patients in US
today – largest cause of
blindness under 55
1.5MM patients in US as of 2010;
projected 3MM by 2020 – largest
cause of blindness over 65
Rate of occurrence between
0.30 and 0.35 per 100 over
the age of 40
More than 8 million diabetics
in the US develop DR,
increasing 6% each year
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 4
5. Luminate® Human Clinical Trial Results
— Excellent safety profile with more than 350 human intravitreal
injections
— Robust clinical response in DME, wet AMD, and VMT/PVD
— Potent enough for monotherapy
— Extended durability: 3-4 months off treatment
— Anti-VEGF levels of BCVA and OCT improvements
— Improvements seen in anti-VEGF plateaued subjects
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 5
6. Luminate® Clinical Pipeline
In ProgressCompleted Planned
Phase I Phase II Phase III
Anti-angiogenesis
Diabetic Macular Edema
Wet Age-Related Macuclar Degeneration
Vitreolysis
Vitreomacular Traction
Posterior Vitreous Detachment for DR
Clinical
Pre-Clinical Commercial
Phase&Ib/IIa&
Phase&Ib&&
Phase&II&
Phase&I&
Phase&I& 2016.2018&Phase&IIb&
2016.2019&
2015.2017&
2015.2019&Phase&IIb&
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 6
Anti-angiogenesis
Diabetic Macular Edema
Wet Age-Related Macular Degeneration
Vitreolysis
Vitreomacular Traction
Posterior Vitreous Detachment for DR
7. Luminate® Clinical Trial Status
7Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
161 patients enrolled in clinical trials to date
150 additional patients expected to complete DME Phase 2 protocol in 2014-15
Study Details Initiated
Enrollment
Complete
Readout Efficacy
P1 DME + PVD
n=15
E. Europe
Q1 2011 Q4 2011 Oct 2011
8 of 15 subjects improved 3-5 lines
3 months off-treatment
6 of 11 patients developed total
PVD by day 90
P2b DME + PVD
n=150
US (30 sites)
Q4 2014 Sept 2015 Q1 2016
P1b/2a DME Combo
n=40
Mexico, E. Europe
Sep 2013 Q4 2014 H1 2015
P1b/2a Wet AMD
n=22
Mexico, E. Europe
Dec 2012 Q4 2013 Jun 2014
Peak avg. BCVA improvement for
3.2 mg: 5.1 letters 60 days
off-treatment, holding 120 days
off-treatment
P2 VMT
n=84
US, E. Europe
Nov 2013 Jun 2014 Oct 2014
8. US Phase IIb DME + PVD Study
— Randomized, controlled, double masked study
— Study designed to minimize risk and increase repeatability
— Built upon design and results of Phase I DME Study
— Replicates dosage, formulation and dosing schedule
— Efficacy endpoints focused on:
— OCT central subfield thickness and BCVA
— Increased durability: efficacy 3 and 4 months off tx in monotherapy
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 8
— Study initiated October 2014
9. US Phase IIb DME Study + PVD Study
9Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
washout or
treatment naïve
Baseline 1 2 3 4 5 6
Months
● 150 subjects in 5 arms
● 1.0, 2.0, 3.0mg Luminate®
● Avastin®
● Focal Laser
● 3 monthly loading doses, followed monthly
● Luminate® readouts at three and four months off tx
● Duke University Reading Center
10. • Excellent Safety Profile
• No patients lost vision
• No SAEs and AEs were mild
and typically injection related
• Mean peak BCVA improvement:
11 letters (or ~2 lines)
2 months off treatment
• 8 patients improved
3-5 lines
• Improvements held
3+ months off treatment
• Corresponding improvement
of BCVA and CMT
Phase I DME Study: BCVA Improvement
10Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
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 logMAR)
11. • Mean peak
improvement in OCT
CMT: 31% for all
subjects
• Improvement held until
Day 150 (3 months off
treatment)
Phase I DME Study: Change in OCT CMT
11Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
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)
12. Phase Ib/IIa Wet AMD Study
— 6-month, dose-ranging study in Wet AMD
— 3 monthly injections, monotherapy
— 4 months of off-treatment follow-up
— No SAEs reported
— 7 of 7 subjects in 3.2mg dose improved ~4-5 letters in BCVA
measured up to 4 months off-treatment in monotherapy
45 day washout or
treatment naïve
Baseline 1 2 3 4 5 6
Months
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 12
13. Phase II VMT Study (In Progress)
— 3-month study in US and E. Europe
— Double masked, randomized,
placebo-controlled
— Primary endpoint: resolution of VMT
— Duke University Reading Center
— Fully enrolled
— 84 subjects in 3 arms
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 13
14. Moving Forward With Luminate®
ü Differentiated mechanisms of action with
unique benefits
— Anti-integrin vs. ant-VEGF
— Increased durability: 3-4 months off tx
— Ability to tx anti-VEGF plateaued pts
ü Strong safety profile with ~350 human tx
ü Solid efficacy data in multiple vitreo-retinal
indications
ü Moving beyond PoC/Phase 2 studies toward
Phase 3 in multiple indications
ü Strong commitment from world class SAB
ü Leveraging strategic partnerships & financial
investments to execute to commercialization
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 14