Panel Discussion by Alimera Sciences at OIS@ASRS 2016.
Participant:
Dan Myers, CEO- Alimera Sciences
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RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
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Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
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Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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Public Device & Biopharma Ophthalmology Company Showcase - Aerie PharmaceuticalsHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Aerie Pharmaceuticals at OIS@AAO 2016.
Presenter:
Vicente Anido Jr., PhD, CEO & Chairman
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Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Masters of the Industry at OIS@AAO 2016.
Moderated By:
Jim Mazzo, Global President Ophthalmic Devices - Carl Zeiss Meditec
Participants:
Flemming Ornskov, MD, CEO - Shire
Mike Ball, CEO - Alcon
Ashley McEvoy, Company Group Chairman - Johnson & Johnson Vision Care
William J. Link, PhD, Managing Director - Versant Ventures
Ludwin Monz, PhD, President & CEO - Carl Zeiss Meditec
William Meury, Chief Commercial Officer - Allergan
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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - OptheaHealthegy
Panel Discussion by Opthea at OIS@ASRS 2016.
Participant:
Megan Baldwin, PhD, CEO & Managing Director - Opthea
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
Posterior Segment Company Showcase - Allegro Ophthalmics at OIS@AAO 2016.
Presenter:
Vicken Karageozian, MD, President & Chief Medical Officer
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Public Device & Biopharma Ophthalmology Company Showcase - Aerie PharmaceuticalsHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Aerie Pharmaceuticals at OIS@AAO 2016.
Presenter:
Vicente Anido Jr., PhD, CEO & Chairman
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Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Masters of the Industry at OIS@AAO 2016.
Moderated By:
Jim Mazzo, Global President Ophthalmic Devices - Carl Zeiss Meditec
Participants:
Flemming Ornskov, MD, CEO - Shire
Mike Ball, CEO - Alcon
Ashley McEvoy, Company Group Chairman - Johnson & Johnson Vision Care
William J. Link, PhD, Managing Director - Versant Ventures
Ludwin Monz, PhD, President & CEO - Carl Zeiss Meditec
William Meury, Chief Commercial Officer - Allergan
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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - OptheaHealthegy
Panel Discussion by Opthea at OIS@ASRS 2016.
Participant:
Megan Baldwin, PhD, CEO & Managing Director - Opthea
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
Posterior Segment Company Showcase - Allegro Ophthalmics at OIS@AAO 2016.
Presenter:
Vicken Karageozian, MD, President & Chief Medical Officer
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Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Richard's entangled aventures in wonderlandRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
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.
14. 14
Supplemental Growth with
License Deals
Canada
Australia
Israel &
Middle East
Creating additional revenue sources through global licensing agreements
Italy
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
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.
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.
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
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.
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
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.