Posterior Segment Company Showcase - Allegro Ophthalmics

Luminate® for the Treatment of Retinal Diseases

Ophthalmology Innovation SummitOctober 13, 2016

Vicken Karageozian, MDPresident and Chief Medical Officer

Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.1

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What Does Allegro Offer?First in class anti-integrin product (Luminate®) with novel MOA for anti-angiogenesis and vitreolysis

Top line results of Phase 2b DME (Stage 1) monotherapy study released today

~400 human subjects treated with well-tolerated safety

Most programs significantly de-risked Composition of matter IP, solid PK, Tox, and CMC packages

Late stage development with multiple programs in phase 2b or laterDME phase 2b DEL MAR Stage 2 Q2 2017PVD phase 2b PACIFIC data lock Q1 2017VMT phase 3 ready

Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.

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Anti-Angiogenesis

DME Wet AMD

BenefitsIncreased durability

Better safety

New MOA with new treatment options

Vitreolysis

PVD VMT

BenefitsVitreolysis and PVD induction

Better safety

New MOA with new treatment options


Human Clinical Studies Update:DEL MAR DME Phase 2b –

(Stage 1) Top Line

4Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.

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136 subjects enrolled across 32 US sites1.0, 2.0, and 3.0 mg Luminate (3 injections) compared to Avastin (6 injections)Luminate vs. Avastin in monotherapyPrimary endpoint was 12 weeks off Luminate treatment; efficacy in mean BCVA and OCT improvementsQ3 data lock for Stage 1 study

DEL MAR US Phase IIb DME Study (Stage 1)

Phase 2b – Stage 1: 6 months follow up

washout or treatment naïve

Baseline 1 2 3 4 5 6Months


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Change in BCVA Letters Read Over Time With 95% Confidence Interval


Study Met Primary EndpointMean BCVA non-inferiority at study week 20 (≤3 letters BCVA)7.0 letters vs 5.2 letters12 weeks off Luminate vs 4 weeks off Avastin

0 4 8 12 16 20 24-10

-5

0

5

10

15

20

2.8 2.9 1.84.7 5.2

2.6

3.55.8 6.1 6.4 7.0 6.3

Luminate 1.0 mgAvastin 1.25 mg

Mai

n C

hang

e

Week from Baseline


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Change in Central Retinal Thickness Over Time With 95% Confidence Interval


0 4 8 12 16 20 24-250

-200

-150

-100

-50

0

50

100

-28.0 -25.0 -28.0-67.0 -77.0 -97.0

-77.0 -85.0-104.0 -120.0 -104.0 -106.0

Luminate 1.0 mgAvastin 1.25 mg

Mai

n C

hang

e

Study Met Secondary EndpointMean OCT CMT non-inferiority at study week 20 (≤30µ)

-104µ vs -77µ at study week 20, 12 weeks post Luminate load-106µ vs -97µ at study week 24, 16 weeks post Luminate load

Week from Baseline




Baseline

Study Week 16(8 weeks post load)


Example #1: Luminate



Baseline


Example #2: Luminate



DEL MAR US Phase IIb DME Study (Stage 1)Example #3:

LuminateBaseline



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Non-inferiority to anti-VEGF with half the number of injections

Met secondary endpoint by OCT central macular thickness

Met primary endpoint by best corrected visual acuity

Data confirms 12 week monotherapy durability

Top line data demonstrates Luminate with

non-inferiority to Avastin at the

primary endpoint of study week 20

Robust activity with new MOA of this new anti-integrin class of drugs in DME

Very comparable safety reporting between treatment and control groups

No drug related SAEs reported for the Luminate arms


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Moving Forward With Luminate®

Excellent safety profile ~400 subjects treated to date

In multiple Phase 2 US studies in DME (stage 2) & PVD that will readout in next ~9 months

Differentiated mechanisms of action with unique benefits

New MOA – Anti-integrin vs. anti-VEGFSimilar potency to Anti-VEGFPotent enough for monotherapy12 weeks durability in DMENew treatment optionsShort term path to commercial availability

Phase 2 DME monotherapy study: met primary endpoint


Anticipate Phase 3 studies to be conducted with pre-filled, disposable syringes developed by Allegro

Thank You



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Posterior Segment Company Showcase - Allegro Ophthalmics