will sustained release ocular formations revolutionise the retinal therapeutics market? ·...
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WILL SUSTAINED RELEASE OCULAR FORMULATIONS REVOLUTIONISE THE
RETINAL THERAPEUTICS MARKET?
GROUP 12
DARA BELL
ARRON COLEMAN
LARA GIBNEY
MIKEY O’CONNOR
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RETINAL THERAPEUTICS MARKET VALUED AT OVER $3 BILLION IN 2013.
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DIABETIC RETINOPATHY (DR)/ DIABETIC MACULAR EDEMA (DME)
• Leading cause of blindness in working-aged population affecting over 8 million
people living in the U.S.
• Abnormal growth of blood vessels in attempt to restore normal bloodflow to
ischemic retina.
• Leads to development of diabetic macular edema (DME).
• Poorly developed blood vessels cause leakage of water, blood cells and proteins
into surrounding retinal tissue.
• Results in dysfunction of macula and decreased vision.
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AGE RELATED MACULAR DEGENERATION (AMD)
• Degenerative retinal disease causing progressive loss of central vision.
• Leading cause of irreversible vision loss in individuals over the age of 50
affecting 11 million people in the U.S.
• Promotes the growth of new, weak blood vessels behind the retina that leak lipids
and serum into macular cells
• Leads to progressive death of macular cells.
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CURRENT PHARMACOLOGICAL TREATMENTS
• Growth of immature endothelial blood vessel in DR and AMD promoted by
vascular endothelial growth factor (VEGF).
• Current treatments aimed at inhibiting VEGF and reducing blood vessel formation.
• All current anti-VEGF treatments are in the form of intra-vitreal injections.
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PROBLEMS WITH CURRENT PRODUCTS ON THE MARKET ?
• Risks associated with intra-vitreal injections.
• Administration requires an opthalmologist.
• Dosage frequency.
• Cost effectiveness.
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CANDIDATES FOR SRDF:
• Have neither a very long (>8 hours) nor a very
short half life (<2 hours)
• Possess a therapeutic index
• Contain desirable absorption and solubility
characteristics
• Administered in relatively small doses
• Used for treating chronic instead of acute
conditions.
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POSTERIOR SOLUTIONS:
Figure1. Intra-vitreal implants, biodegradable
or non-biodegradable
Figure 2. Sustained Release of an Anti-
Glaucoma Drug: Demonstration of Efficacy of
a Liposomal Formulation in the Rabbit Eye
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ADVANTAGES OF SRDF OVER OTHER CONVENTIONAL
FORMS:
• Decreased local and systemic side effects which results in reduced gastrointestinal irritation
• Reduction in cost
• Reduction in dosing frequency
• Reduction of fluctuations in circulating drug levels
• Improvement in patient compliance and reduced patient care time
Figure 1. Plasma Drug Concentration Profile for Conventional Release, a Sustained Release and Zero Order Controlled Release
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DISADVANTAGES OF SRDF:
• Dose dumping.
• Poor systemic availability in
general.
• Reduction in the potential for
dosage adjustment.
• It is unpredictable for in-vitro
and in-vivo correlation.
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CURRENT SUSTAIN RELEASE THERAPIES FOR DME/ AMD
OZURDEX (DEXAMETHASONE IMPLANT)
• A sustain release biodegradable implant
• FDA approved since 2014
• A corticosteroid that blocks chemical pathways which leads to inflammation, leakage from the
retinal blood vessels and swelling of the retina.
• Advantages: long duration (4-6 months)
Small injection, no stitches needed
• Disadvantages: can cause increased I.O.P, therefore regular monitoring is necessary.
Can potentially result in cataracts
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OZURDEX: HOW IT WORKS?
• Ozurdex is an implant which gets injected into the
vitreous humour of the eye.
• The biodegradable material of the implant mixes
with the dexamethasone (the active drug) forming
the rod shaped implant.
• Once injected into the eye, the vitreous gel causes
the implant to slowly dissolve, releasing the drug
dexamethasone.
• It works by suppressing inflammation which inhibits
inflammatory cytokines and results in decreased
oedema, capillary leakage, fibrin deposition and
migration of inflammatory cells.
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FLUOCINOLONE ACETONIDE (FA) INTRAVITREAL IMPLANT (ILUVIEN)
• A sustain released non-biodegradable implant
• FDA approved since 2014
• Advantages: long duration (up to 36 months)
• Disadvantages: eye infections, inflammation or
increased IOP and cataracts.
• How it works: iluvien is similar to ozurdex as it is
a small implant injected into the eye. The drug
released from the implant is fluocinolone
acetonide.
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THE FUTURE OF THE RETINAL THERAPEUTICS MARKET
1. Future projected prevalence of key diseases
2. Factors affecting demand for retinal products
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INCREASING DEMAND FOR OCULAR THERAPY AS A RESULT OF A GREYING POPULATION
PROJECTED NO. OF PEOPLE AGED OVER 60 (GLOBAL) UP TO 2050
The over 60 age group will rise from 750 million in 2010 to roughly 1 billion in 2020 and 2 billion in 2050 -
Retinal diseases such as macular degeneration, and Diabetic retinopathy occur at a rate of 7.6%, and 1.9%,
respectively, in populations over 40
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RISE IN RETINAL DISEASE PROMINENCE
AMD - approx. 18 million in 2010-35 million in 2020
-More than 25 companies are currently working on developing sustained release drug delivery systems
Env1305, sustained release treatment of amd. -Long
term studies to assess pharm kinetics starting this year
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RISE IN RETINAL DISEASE PROMINENCE
Diabetic Macular Edema
-Approx. 33 million people worldwide-
-ENV1105 treatment of DME , sustained release,
minimum of 6 months
retinal diseases market –$6500m in 2013 to $12,400m in 2019
Sustained ocular release market-2014 Market research study predicted The overall market is likely to be more
than USD 6 billion in the coming decade. [Smith- 2015].
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38%
43; 43%
12%
7%
Retinal market 2013
DME AMD RVO Other
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References1. http://jamanetwork.com/journals/jamaophthalmology/fullarticle/419278
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3306122/
3. http://www.envisiatherapeutics.com/
4. https://www.slideshare.net/prashantmane01/sustained-release-drug-delivery-system?next_slideshow=1
5. "OZURDEX®". Ozurdex.com. N.p., 2017. Web. 18 Apr. 2017.
6. "ILUVIEN For Diabetic Macular Edema - Iluvien". Iluvien. N.p., 2017. Web. 19 Apr. 2017.
7. Schmit-Eilenberger, Vera. "A Novel Intravitreal Fluocinolone Acetonide Implant (Iluvien&Reg;) In The Treatment of Patients With Chronic
Diabetic Macular Edema That Is Insufficiently Responsive To Other Medical Treatment Options: A Case Series". Clinical Ophthalmology
(2015): 801. Web.
8. Dugel, Pravin U., Francisco Bandello, and Anat Loewenstein. "Dexamethasone Intravitreal Implant In The Treatment Of Diabetic Macular
Edema". Clinical Ophthalmology (2015): 1321. Web.
9. http://www.prnewswire.com/news-releases/sustained-release-ocular-drug-delivery-systems-2015---2025-2nd-edition-300158356.html
10. http://www.envisiatherapeutics.com/overview
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References
11. https://www.reviewofophthalmology.com/article/systemic-drugs-with-ocular-side-effects
12. http://www.ncbiotech.org/article/envisia-raises-165m-advance-eye-therapies/168911
13. http://www.harriswilliams.com/sites/default/files/content/hwco_hcls_vision_industry_updatev2.pdf
14. https://eandv.biomedcentral.com/articles/10.1186/s40662-015-0026-2
15. https://www.visiongain.com/Press_Release/768/Retinal-Disease-Pharmaceutical-Sales-Will-Reach-12-5bn-In-2019-A-New-
Visiongain-Study-Predicts
16. Macular Degeneration (AMD) And Other Retinal Diseases: World Drug Industry And Market 2015-2025 [2015]