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OIS Meeting Presentation
August 8, 2016
2
Safe Harbor Statement
This presentation contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding,
among other things, that sales are escalating as practices are being reimbursed regularly and on a timely basis, the opportunity for significant
growth and market penetration of ILUVEN and that the data on ILUVIEN will drive growth, Alimera’s belief that only one Phase 3 clinical trial
will be able to establish adequate evidence of safety and efficacy for ILUVIEN and obtain FDA approval for additional indications of ILUVIEN.
Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay,
divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Words such
as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplate,” “predict,” “project,” “target,” “likely,” “potential,”
“continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions are intended to identify forward-
looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause
actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to
differ include, but are not limited to, Alimera’s ability to close on additional or alternative debt or equity financing in an appropriate fashion,
Alimera failing to meet its financial covenants under its amended loan facility with Hercules Capital, Inc., which could materially affect Alimera’s
commercialization of ILUVIEN, market acceptance of ILUVIEN in the U.S. and Europe, including physicians’ ability to obtain reimbursement and
seasonality, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form
10-Q for the quarter ended March 31, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s
website at http://www.sec.gov. Additional factors may also be set forth in those sections of Alimera’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2016, to be filed with the SEC in the third quarter of 2016. In addition to the risks described above and in Alimera’s Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or
unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera
will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance
can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained
in this presentation are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too
heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the
date of this presentation (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly
update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
22 © 2016 Alimera Sciences, All Rights Reserved2
3
Persistent Disease Requires
Persistent Therapy
4
Full instructions can be found in the ILUVIEN Summary of Product Characteristics
Tight
junctions
Antioxidant
capacity
of RPE
Taurine
transport
of RPE
Leukostais
Chronic
inflammation
Capillary
nonperfusion
Pericyte
loss
Hypoxia
Thickened
basement
membrane
DME
Occludin
Cytokines
ICAM-1
VEGF
Stromal-derived
factor-1
Endothelin 1
PEDF
PKC
HIF-1α
AGE & RAGE
DAG
Aldose
reductase
NOS
DME
Diabetic Macular Edema Contributing
Anatomical/Physiological Changes & Biochemical Factors
xAffected by
anti-VEGF
x
?
A&P Changes Biochemical Factors
Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79.
Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp
Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS.
Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al.
Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701.
AGE, advanced glycation end products; DAG, diacylglycerol; HIF,
hypoxia-inducible factor; ICAM, intercellular adhesion molecule;
NOS, nitric oxide synthase; PEDF, pigment epithelium-derived
factor; PKC, protein kinase C; RAGE, receptor for AGE; RPE, retinal
pigment epithelium; VEGF, vascular endothelial growth factor.
5
Full instructions can be found in the ILUVIEN Summary of Product Characteristics
Tight
junctions
Antioxidant
capacity
of RPE
Taurine
transport
of RPE
Leukostais
Chronic
inflammation
Capillary
nonperfusion
Pericyte
loss
Hypoxia
Thickened
basement
membrane
DME
x
x
x
xx
Occludin
Cytokines
ICAM-1
VEGF
Stromal-derived
factor-1
Endothelin 1
PEDF
PKC
HIF-1α
AGE & RAGE
DAG
Aldose
reductase
NOS
x
x
xx
DME
xAffected by
corticosteroids
Diabetic Macular Edema Contributing
Anatomical/Physiological Changes & Biochemical Factors
A&P Changes Biochemical Factors
x
AGE, advanced glycation end products; DAG, diacylglycerol; HIF,
hypoxia-inducible factor; ICAM, intercellular adhesion molecule;
NOS, nitric oxide synthase; PEDF, pigment epithelium-derived
factor; PKC, protein kinase C; RAGE, receptor for AGE; RPE, retinal
pigment epithelium; VEGF, vascular endothelial growth factor.
Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79.
Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp
Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS.
Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al.
Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701.
Intravitreal Steroid Exposure Between
FAc, IVTA and DEX
IVTA in Rabbit
Vitreous1
DEX in Monkey
Vitreous2
1. Kamppeter BA, et al. Ophthalmology. 2008;115:1372-1375. 2. Chang-Lin JE, et al. Invest Ophthalmol Vis Sci. 2011;52:4605-4609.
TriamcinoloneConcentration
(±SD),ng/mL
Days
0.0001
0.001
0.01
0.1
1
10
100
1000
10000
100000
1000000
0 60 120 180 240
0.2 μg/d FAc
0.5 μg/d FAc
MeanFAcConcentration
(±SD),ng/g
Days
FAc in Rabbit
Vitreous
• FAc implants release consistent, low dose of corticosteroid
1
10
100
1000
10000
100000
1000000
10000000
0 30 60 90 120
IVTA 4 mg IVTA 8mg
Dexamethasone
Concentration(ng/mLorng/g) Days
1000000
100000
10000
1000
100
10
1
0.1
0.01
0.001
0.0001
0 60 120 180 240
Vitreous
(implant)
Vitreous
(no implant)
Retina
Plasma
6
7
0
5
10
15
20
25
30
35
40
0 3 6 9 12 15 18 21 24 27 30 33 36
Control (n = 185)
0.2 µg/d FAc (n = 376)
0.5 µg/d FAc (n = 395)
0
5
10
15
20
25
30
35
40
0 3 6 9 12 15 18 21 24 27 30 33 36
Control (n = 185)
0.2 µg/d FAc (n = 376)
0.5 µg/d FAc (n = 395)
Months
PatientsWith≥15-LetterImprovement
inBCVAFromBaseline,%
The 0.2 µg/d dose of FAc has been submitted for regulatory approval.
27.8%
28.7%
18.9%
P = .018
Primary readout
28.6%
28.7%
16.2%
P = .002
The FAME Study Met its Primary Endpoint
(ITT Population)
8
Indication and Usage
ILUVIEN® (fluocinolone acetonide intravitreal implant)
0.19 mg is indicated for the treatment of diabetic
macular edema (DME) in patients who have been
previously treated with a course of corticosteroids and
did not have a clinically significant rise in intraocular
pressure.
See Full Prescribing Information.
9
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
• ILUVIEN is contraindicated in patients with active or
suspected ocular or periocular infections including most viral
diseases of the cornea and conjunctiva including active
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
varicella, mycobacterial infections and fungal diseases.
• ILUVIEN is contraindicated in patients with glaucoma, who
have cup to disc ratios of greater than 0.8.
• ILUVIEN is contraindicated in patients with known
hypersensitivity to any components of this product.
10
IMPORTANT SAFETY INFORMATION (cont.)
WARNINGS AND PRECAUTIONS
• Intravitreal injections, including those with ILUVIEN, have been associated with
endophthalmitis, eye inflammation, increased intraocular pressure, and retinal
detachments. Patients should be monitored following the intravitreal injection.
• Use of corticosteroids including ILUVIEN may produce posterior subcapsular
cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may
enhance the establishment of secondary ocular infections due to bacteria, fungi, or
viruses. Corticosteroids are not recommended to be used in patients with a history
of ocular herpes simplex because of the potential for reactivation of the viral
infection.
• Patients in whom the posterior capsule of the lens is absent or has a tear are at risk
of implant migration into the anterior chamber.
ADVERSE REACTIONS
• In controlled studies, the most common adverse reactions reported were cataract
development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of ≥ 10
mm Hg (ILUVIEN 34%; sham 10%).
11
Association of Prior Intravitreal Steroid Injection and IOP-
Lowering Surgery
• Of the 72 patients who received prior ocular steroid
injection (0.2 μg/d FAc group), 0 required surgery for
elevated IOP
Data on File. Alimera Sciences.
NS, not significant.
a Includes trabeculectomy, glaucoma surgery, and vitrectomy for elevated IOP.
b P values based on Fisher's exact test comparing proportions within each treatment group.
Prior Intravitreal Steroid
Treatment
No Prior Intravitreal Steroid
Treatment
0.2 µg/d FAc
(n = 72)
0.2 µg/d FAc
(n = 294)
IOP-Lowering Surgerya in
Study Eye, n (%)
0 18 (6.1)
P valueb for prior vs no prior .030
Location
N° of eyes
(pts)
Follow-up
Baseline BCVA
ETDRS Score (change)
Baseline CFT,
microns
(change)
IOP Change and management
Medisoft 2nd
data extract
results (13 sites in the UK)1
290 eyes
(258 pts)
Up to 722
days
52.8 (less than 5 letters
with stable vision up to
18 months)
517.7
(-148.5 µm at last
observation)
a. IOP elevation >30 mmHg, 6.6%
b. Emergent IOP-lowering drops, 14.8%
c. Rate of trabeculoplasty, 0%
d. Rate of incisional surgery, 0%
IRISS 2nd
data extract
(37 units in UK, DE, PT)2
328 eyes
(292 pts)
Up to 763
days
50.9 (~5 letters with
stable vision up to 18
months)
NN
a. IOP elevation >30 mmHg, 8.2%
b. Emergent IOP-lowering drops, 18.4%
c. Rate of laser trabeculoplasty, 0%
d. Rate of incisional surgery, 0.6%
ILUVIEN Real-world Data Studies
1. Bailey C. Alimera Sciences symposium at EURETINA 2015.
2. Chakravarthy U. Alimera Sciences Advisory Board held on March 12 2016 in Paris, France.
13
Global Commercialization Status
ILUVIEN®’s Commercialization Footprint is Large, and
we are Making Inroads to New Territory
14
Supplemental Growth with
License Deals
Canada
Australia
Israel &
Middle East
Creating additional revenue sources through global licensing agreements
Italy
• Second quarter sequential growth of 66% to $9.6
million
• Strong U.S. account growth continues
• Comfort with reimbursement process improving
EYES TREATED WITH
ILUVIEN® TO DATE
6,000
Q2 2016 Highlights
1Q16 2Q16
1515 © 2016 Alimera Sciences, All Rights Reserved15
$9.6M
$5.8M
Revenue growth
OVER
+66%
1616 © 2016 Alimera Sciences, All Rights Reserved16
New U.S.
Accounts in
Q2 2016
50
US Account Growth Continues
Continued Market Penetration Driven by Salesforce Execution
3/31/2016 6/30/2016
363U.S. Accounts
413U.S. Accounts
1717 © 2016 Alimera Sciences, All Rights Reserved17
United States
Rapid Growth and Account Penetration
Record Quarterly
Revenue
Driven by growth in new accounts as well as
increased penetration into historical accounts
Customer Confidence
Building
As evidenced by some accounts skipping BI
process
1Q16 2Q16
US Revenue Growth
$7.2M
$4.1M
+76%
1818 © 2016 Alimera Sciences, All Rights Reserved18
Europe
Back on Track
German Unit Volume
Increases
5th consecutive quarter
UK Returns to Year-
Over-Year Growth
New quarterly revenue record set
1Q16 2Q16
Europe Revenue Growth
$2.3M
$1.7M
+35%
FDA Meetings
Real world experience mimicking FAME pivotal trials
Engaged in
discussions with the
FDA regarding two
potential new
indications:
• Retinal Vein Occlusion
• Non-proliferative diabetic
retinopathy
20
ILUVIEN®: Unique DME Treatment
Continuous Microdosing for Patients Who Require
Persistent Treatment
21

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RETINA COMPANY SHOWCASE- Alimera Sciences

  • 2. 2 Safe Harbor Statement This presentation contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, that sales are escalating as practices are being reimbursed regularly and on a timely basis, the opportunity for significant growth and market penetration of ILUVEN and that the data on ILUVIEN will drive growth, Alimera’s belief that only one Phase 3 clinical trial will be able to establish adequate evidence of safety and efficacy for ILUVIEN and obtain FDA approval for additional indications of ILUVIEN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplate,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions are intended to identify forward- looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Alimera’s ability to close on additional or alternative debt or equity financing in an appropriate fashion, Alimera failing to meet its financial covenants under its amended loan facility with Hercules Capital, Inc., which could materially affect Alimera’s commercialization of ILUVIEN, market acceptance of ILUVIEN in the U.S. and Europe, including physicians’ ability to obtain reimbursement and seasonality, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at http://www.sec.gov. Additional factors may also be set forth in those sections of Alimera’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, to be filed with the SEC in the third quarter of 2016. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in this presentation are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this presentation (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. 22 © 2016 Alimera Sciences, All Rights Reserved2
  • 4. 4 Full instructions can be found in the ILUVIEN Summary of Product Characteristics Tight junctions Antioxidant capacity of RPE Taurine transport of RPE Leukostais Chronic inflammation Capillary nonperfusion Pericyte loss Hypoxia Thickened basement membrane DME Occludin Cytokines ICAM-1 VEGF Stromal-derived factor-1 Endothelin 1 PEDF PKC HIF-1α AGE & RAGE DAG Aldose reductase NOS DME Diabetic Macular Edema Contributing Anatomical/Physiological Changes & Biochemical Factors xAffected by anti-VEGF x ? A&P Changes Biochemical Factors Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79. Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS. Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al. Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701. AGE, advanced glycation end products; DAG, diacylglycerol; HIF, hypoxia-inducible factor; ICAM, intercellular adhesion molecule; NOS, nitric oxide synthase; PEDF, pigment epithelium-derived factor; PKC, protein kinase C; RAGE, receptor for AGE; RPE, retinal pigment epithelium; VEGF, vascular endothelial growth factor.
  • 5. 5 Full instructions can be found in the ILUVIEN Summary of Product Characteristics Tight junctions Antioxidant capacity of RPE Taurine transport of RPE Leukostais Chronic inflammation Capillary nonperfusion Pericyte loss Hypoxia Thickened basement membrane DME x x x xx Occludin Cytokines ICAM-1 VEGF Stromal-derived factor-1 Endothelin 1 PEDF PKC HIF-1α AGE & RAGE DAG Aldose reductase NOS x x xx DME xAffected by corticosteroids Diabetic Macular Edema Contributing Anatomical/Physiological Changes & Biochemical Factors A&P Changes Biochemical Factors x AGE, advanced glycation end products; DAG, diacylglycerol; HIF, hypoxia-inducible factor; ICAM, intercellular adhesion molecule; NOS, nitric oxide synthase; PEDF, pigment epithelium-derived factor; PKC, protein kinase C; RAGE, receptor for AGE; RPE, retinal pigment epithelium; VEGF, vascular endothelial growth factor. Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79. Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS. Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al. Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701.
  • 6. Intravitreal Steroid Exposure Between FAc, IVTA and DEX IVTA in Rabbit Vitreous1 DEX in Monkey Vitreous2 1. Kamppeter BA, et al. Ophthalmology. 2008;115:1372-1375. 2. Chang-Lin JE, et al. Invest Ophthalmol Vis Sci. 2011;52:4605-4609. TriamcinoloneConcentration (±SD),ng/mL Days 0.0001 0.001 0.01 0.1 1 10 100 1000 10000 100000 1000000 0 60 120 180 240 0.2 μg/d FAc 0.5 μg/d FAc MeanFAcConcentration (±SD),ng/g Days FAc in Rabbit Vitreous • FAc implants release consistent, low dose of corticosteroid 1 10 100 1000 10000 100000 1000000 10000000 0 30 60 90 120 IVTA 4 mg IVTA 8mg Dexamethasone Concentration(ng/mLorng/g) Days 1000000 100000 10000 1000 100 10 1 0.1 0.01 0.001 0.0001 0 60 120 180 240 Vitreous (implant) Vitreous (no implant) Retina Plasma 6
  • 7. 7 0 5 10 15 20 25 30 35 40 0 3 6 9 12 15 18 21 24 27 30 33 36 Control (n = 185) 0.2 µg/d FAc (n = 376) 0.5 µg/d FAc (n = 395) 0 5 10 15 20 25 30 35 40 0 3 6 9 12 15 18 21 24 27 30 33 36 Control (n = 185) 0.2 µg/d FAc (n = 376) 0.5 µg/d FAc (n = 395) Months PatientsWith≥15-LetterImprovement inBCVAFromBaseline,% The 0.2 µg/d dose of FAc has been submitted for regulatory approval. 27.8% 28.7% 18.9% P = .018 Primary readout 28.6% 28.7% 16.2% P = .002 The FAME Study Met its Primary Endpoint (ITT Population)
  • 8. 8 Indication and Usage ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. See Full Prescribing Information.
  • 9. 9 IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS • ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. • ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. • ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.
  • 10. 10 IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS • Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection. • Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection. • Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber. ADVERSE REACTIONS • In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of ≥ 10 mm Hg (ILUVIEN 34%; sham 10%).
  • 11. 11 Association of Prior Intravitreal Steroid Injection and IOP- Lowering Surgery • Of the 72 patients who received prior ocular steroid injection (0.2 μg/d FAc group), 0 required surgery for elevated IOP Data on File. Alimera Sciences. NS, not significant. a Includes trabeculectomy, glaucoma surgery, and vitrectomy for elevated IOP. b P values based on Fisher's exact test comparing proportions within each treatment group. Prior Intravitreal Steroid Treatment No Prior Intravitreal Steroid Treatment 0.2 µg/d FAc (n = 72) 0.2 µg/d FAc (n = 294) IOP-Lowering Surgerya in Study Eye, n (%) 0 18 (6.1) P valueb for prior vs no prior .030
  • 12. Location N° of eyes (pts) Follow-up Baseline BCVA ETDRS Score (change) Baseline CFT, microns (change) IOP Change and management Medisoft 2nd data extract results (13 sites in the UK)1 290 eyes (258 pts) Up to 722 days 52.8 (less than 5 letters with stable vision up to 18 months) 517.7 (-148.5 µm at last observation) a. IOP elevation >30 mmHg, 6.6% b. Emergent IOP-lowering drops, 14.8% c. Rate of trabeculoplasty, 0% d. Rate of incisional surgery, 0% IRISS 2nd data extract (37 units in UK, DE, PT)2 328 eyes (292 pts) Up to 763 days 50.9 (~5 letters with stable vision up to 18 months) NN a. IOP elevation >30 mmHg, 8.2% b. Emergent IOP-lowering drops, 18.4% c. Rate of laser trabeculoplasty, 0% d. Rate of incisional surgery, 0.6% ILUVIEN Real-world Data Studies 1. Bailey C. Alimera Sciences symposium at EURETINA 2015. 2. Chakravarthy U. Alimera Sciences Advisory Board held on March 12 2016 in Paris, France.
  • 13. 13 Global Commercialization Status ILUVIEN®’s Commercialization Footprint is Large, and we are Making Inroads to New Territory
  • 14. 14 Supplemental Growth with License Deals Canada Australia Israel & Middle East Creating additional revenue sources through global licensing agreements Italy
  • 15. • Second quarter sequential growth of 66% to $9.6 million • Strong U.S. account growth continues • Comfort with reimbursement process improving EYES TREATED WITH ILUVIEN® TO DATE 6,000 Q2 2016 Highlights 1Q16 2Q16 1515 © 2016 Alimera Sciences, All Rights Reserved15 $9.6M $5.8M Revenue growth OVER +66%
  • 16. 1616 © 2016 Alimera Sciences, All Rights Reserved16 New U.S. Accounts in Q2 2016 50 US Account Growth Continues Continued Market Penetration Driven by Salesforce Execution 3/31/2016 6/30/2016 363U.S. Accounts 413U.S. Accounts
  • 17. 1717 © 2016 Alimera Sciences, All Rights Reserved17 United States Rapid Growth and Account Penetration Record Quarterly Revenue Driven by growth in new accounts as well as increased penetration into historical accounts Customer Confidence Building As evidenced by some accounts skipping BI process 1Q16 2Q16 US Revenue Growth $7.2M $4.1M +76%
  • 18. 1818 © 2016 Alimera Sciences, All Rights Reserved18 Europe Back on Track German Unit Volume Increases 5th consecutive quarter UK Returns to Year- Over-Year Growth New quarterly revenue record set 1Q16 2Q16 Europe Revenue Growth $2.3M $1.7M +35%
  • 19. FDA Meetings Real world experience mimicking FAME pivotal trials Engaged in discussions with the FDA regarding two potential new indications: • Retinal Vein Occlusion • Non-proliferative diabetic retinopathy
  • 20. 20 ILUVIEN®: Unique DME Treatment Continuous Microdosing for Patients Who Require Persistent Treatment
  • 21. 21

Editor's Notes

  1. ILUVIEN SPC. http://www.medicines.org.uk/emc/medicine/27636. 2013. Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79. Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS. Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al. Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701. As we know, the effectiveness of steroids have been the mainstay of anti-inflammatory therapy for the past 50 years. Emerging scientific evidence is helping us to better understand the broad array of effects corticosteroids have on both anatomical and biochemical factors associated with DME. (bring in graphics at this point). The following diagrams provide a general snapshot of the current scientific understanding of where steroids work – and as we can see, steroids affect multiple pathways… both anatomically and biochemically.
  2. ILUVIEN SPC. http://www.medicines.org.uk/emc/medicine/27636. 2013. Stewart MW. Curr Diab Rep. 2012;12:364-375. Funatsu H, et al. Ophthalmol. 2009;116:73-79. Yoshimura T, et al. PLoS One. 2009;4:e8158. Funk M, et al. Retina. 2010;30:1412-1419. Kern TS. Exp Diabetes Res. 2007;2007:95103. Ciulla T, et al. Diabetes Care. 2003;26:2653-2664. Tang J and Kern TS. Prog Retin Eye Res. 2011;30:343-358. Bhagat N, et al. Surv Ophthalmol. 2009; 54:1-32. Zhou J, et al. Curr Eye Res. 2012;37:416-420. El-Sherbeny A, et al. Invest Ophthalmol Vis Sci. 2004;45: 694-701. As we know, the effectiveness of steroids have been the mainstay of anti-inflammatory therapy for the past 50 years. Emerging scientific evidence is helping us to better understand the broad array of effects corticosteroids have on both anatomical and biochemical factors associated with DME. (bring in graphics at this point). The following diagrams provide a general snapshot of the current scientific understanding of where steroids work – and as we can see, steroids affect multiple pathways… both anatomically and biochemically.
  3. MENTION that Difference in PK release doesn’t necessarily reflect the therapeutic window IVTA implant is 6 mg Dex is High blue line is fake, it’s what is still in the implant – BK wants to remove the turquoise line
  4. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
  5. DOF #86 S9_7_iop_related Table 9.11 Study Eye P-values based on Fisher's exact test comparing proportions within each treatment group
  6. References 1. Dupas B et al. Alimera Sciences symposium at EURETINA 2015; 2. Figueira J et al ARVO 2016: poster #3257; 3. Bailey C. Alimera Sciences symposium at EURETINA 2015; 4. Bailey et al RCOphth 2016: poster #101. 5. Chakravarthy U. Alimera Sciences advisory board held on March 12 2016 in Paris, France. 6. Taylor et al RCOphth 2016: poster #110. Massin trial treatment groups Two groups were defined in advance: Group 1 included patients having received previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit and no previous treatment with intraocular anti-VEGF therapy (anti-VEGF considered inappropriate); Group 2 included patients previously treated in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and with past history of ≥3 monthly anti-VEGF treatments.