automated microneedle injector for intravitreal or...
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KMG PHARMA LLC
Automated Microneedle Injector
for Intravitreal or Subconjunctival
Drug Delivery
2015
2015 KMG Pharma LLC
Automated Microneedle Injector
Key Features
Delivery of drugs into the intravitreal or subconjunctival spaces using low pressure jet injection equipped with a micro-needle that only penetrates into the sclera
Designed to be easily and precisely placed on the conjunctiva, particularly on the pars plana
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2015 KMG Pharma LLC
Automated Microneedle Injector
Advantages
Fast and precise positioning of the device on the conjunctiva, particularly on the pars plana, the area of predilection for intravitreal injection
Low risk of damage to the eye because the microneedle only penetrates into the sclera and because of precise positioning and stabilization of the device
Low risk of infection due to lack of direct penetration by the needle into the vitreous cavity
Short time required to execute the procedure because of the ease of use of the device
Potential improved user acceptance resulting from a shorter needle and the the reduced risk of ocular damage as compared to classic injection techniques
Potential to deliver a wide variety of conventional drugs, biopharmaceuticals, and microparticles
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2015 KMG Pharma LLC
Automated Microneedle Injector
Specs
Microneedle Length 0.1 – 1 mm. Gauge ≥ 27
Partial penetration into the sclera
Guide for the jet stream
Platform Made of soft elastomeric materials. 6 mm in diameter
Allows precise positioning on the pars plana
Adhesion and stabilization of the device on the conjunctiva
Drug reservoir Refillable cartridge
Disposable cartridge integrated with microneedle and platform
Jet injector Pressure ≤ 1000 psi
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2015 KMG Pharma LLC
Automated Microneedle Injector
Schematic View 5
2015 KMG Pharma LLC
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Intravitreal Automated Microneedle Injector
Application to the Pars Plana (Artist View)
Fluid flow
Micro-needle
Fluid flow
Microneedle
Pars plana
2015 KMG Pharma LLC
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Subconjunctival Automated Microneedle Injector
Application to the Conjunctiva (Artist View)
2015 KMG Pharma LLC
Automated Microneedle Injector
Activities Completed to Date
Lab prototype manufactured
Initial in vitro tests conducted in gelatin gels to
evaluate performance
Second series of tests conducted in
enucleated albino rabbit eyes
Study conducted ex vivo in albino rabbits
Study conducted in vivo in albino rabbits
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2015 KMG Pharma LLC
Automated Microneedle Injector
Lab Prototype 9
2015 KMG Pharma LLC
Ex Vivo Intraocular Injection of a Dye using an
Automated Microneedle Injector 10
Pressure Injection time Energy
psi s j Intravitreal Subconjunctival Wet
974 0.04 0.34 8 0 0
657 0.05 0.23 2 4 0
156 0.11 0.05 0 6 0
74 0.16 0.03 0 6 0
29 0.25 0.01 0 2 4
Number of injections
2015 KMG Pharma LLC
Representative Example of an Intravitreal Injection in an
Enucleated Rabbit Eye using an Automated Microneedle
Injector 11
f d
c b
e
a
Injection point
Injection point
Pre-injection Post-injection Post-injection
Post-dissection Post-dissection Post-dissection
Vitreous side Vitreous side Vitreous side
2015 KMG Pharma LLC
Representative Example of a Subconjunctival Injection in an
Enucleated Rabbit Eye using an Automated Microneedle
Injector 12
Post-injection Post-dissection
Vitreous side
2015 KMG Pharma LLC
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In Vivo Intraocular Injection of a Dye using an
Automated Microneedle Injector
Pressure Injection time Energy
psi s j Intravitreal Subconjunctival Wet
974 0.04 0.34 3 0 0
657 0.05 0.23 3 0 0
156 0.11 0.05 0 3 0
Number of injections
2015 KMG Pharma LLC
Rabbit Eye Following In Vivo Intravitreal Injection
of a Dye using an Automated Microneedle Injector
Control intravitreal injection using a 27 gauge
needle and syringe Cross section of frozen eye. Insert
shows the bluish injection area and a
black mark indicating the 12:00 o’clock
orientation
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2015 KMG Pharma LLC
Rabbit Eye Following In Vivo Subconjunctival Injection
of a Dye using an Automated Microneedle Injector
Control subconjunctival injection using a 27
gauge needle and syringe Cross section of frozen eye. Insert
shows the bluish injection area
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2015 KMG Pharma LLC
Histology (H&E) of Rabbit Eyes Following In Vivo
Intravitreal or Subconjunctival Injection using an
Microneedle Automated Injector 16
Microneedle
injector
(974 psi)
Microneedle
injector (156 psi)
Control (Syringe/27 g needle)
Control (Syringe/27 g needle)
Intravitreal injection Subconjunctival injection
2015 KMG Pharma LLC
Automated Microneedle Injector
Conclusions
Placement of the edge of the platform at the location of the corneoscleral limbus allows precise positioning and application of the microneedle to the pars plana area
A microneedle that penetrates partly through the sclera allows use of relatively low pressures for intravitreal delivery (1000 vs. 4000 psi for conventional jet injection).
Subconjunctival delivery can be achieved successfully with the same device using lower pressures (100 psi)
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2015 KMG Pharma LLC
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Automated Microneedle Injector
Intellectual Property
Issued US patent 7,678,078 (WO2010047753) gives KMG
Pharma exclusive right for an intraocular automated
injector (injection pressures between 50–1000 psi)
comprising a microneedle (0.1-1 mm) and a positioning
platform.
2015 KMG Pharma LLC
Automated Microneedle Injector
Competitive Landscape
So far, no specific devices for intravitreal injection have
been developed and vitreoretinal specialists rely on
conventional syringes and needles.
No devices have been patented/developed for
subconjunctival injection.
A number of companies are attempting to develop
intraocular implants (Bausch &Lomb) or controlled
release formulations (SurModics) for the long term
delivery of drugs into the intravitreal cavity. So far, no
implants or CR formulations have been developed for
biopharmaceuticals.
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2015 KMG Pharma LLC
Automated Microneedle Injector
Market Potential
Large and growing patient population with ocular diseases susceptible
to anti-VEGF therapy (anti-VEGF antibodies, VEGF trap, anti-VEGF
aptamer) that may require intraocular injections.
a http://www.nei.nih.gov/eyedata/
b CMRO, 26, 1587, 2010
c Arch Ophthalmol 126, 513 2008
d Frost and Sullivan: US Leading Ophthalmic Diseases Report
e Diabetic Macular Edema Review Article on the the Digital Journal of Ophthalmology from Harvard University and the
American Diabetes Association
f RBC Capital Markets
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Prevalence
(million)
Incidence
(000 per year)
Growth Rate
(% per year)
Advanced Age-related Macular Degeneration 1.8a 240d 1.6d
Diabetic Macular Edema 1.5b 190e 5e
Central Retinal Vein Occlusion 1.5c 95f TBD
U.S. Population Data
Disease
2015 KMG Pharma LLC
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Automated Microneedle Injector
Drug Device Potential
Rights for US Patent 7083802 secured by KMG Pharma.
This issued US patent claims intraocular (intravitreal and
subconjunctival) injection of Rapamycin or Ascomycin or
Cyclosporin A or Tacrolimus for the treatment of diabetic
retinopathy, retinitis pigmentosa, and age related
macular degeneration. These drugs can be developed
by KMG Pharma for conventional intraocular injection or
in conjunction with KMG Pharma devices.
Other biopharmaceutical drugs of interest can be
developed with KMG Pharma devices.
KMG PHARMA LLC
An expert ophthalmic incubator company