Automated Needleless Injector for Intravitreal or Subconjunctival Drug Delivery KMG PHARMA LLC

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1 Automated Needleless Injector for Intravitreal or Subconjunctival Drug Delivery KMG PHARMA LLC

2 Automated Needleless Injector Key Features 2 Delivery of drugs into the intravitreal or subconjunctival spaces using low pressure jet injection Designed to be easily and precisely placed on the conjunctiva, particularly on the pars plana

3 Automated Needleless Injector Advantages 3 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 of the absence of a needle and because of precise positioning and stabilization of the device Low risk of infection because there is no direct ocular penetration by a needle Short time required to execute the procedure because of the ease of use of the device Potential improved user acceptance resulting from the needleless feature and the reduced risk of ocular damage as compared to classic injection techniques Potential to deliver a wide variety of conventional drugs, biopharmaceuticals, and microparticles

4 Automated Needleless Injector Specs 4 Platform Made of soft elastomeric materials. About 6 mm in diameter Adhesion and stabilization of the device Optimal contact with the surface of the eye Drug reservoir Refillable cartridge Disposable cartridge integrated with microneedle and platform Jet injector Pressure 1000 psi

5 5 Intravitreal Injection using an Automated Needleless Injector (Artist View) Pars plana Fluid flow Fluid flow

6 Subconjunctival Injection using an Automated Needleless Injector (Artist View) 6

7 Automated Needleless Injector Activities Completed to Date 7 Lab prototype manufactured Initial in vitro tests conducted in gelatin gels to evaluate performance Second series of tests conducted in enucleated albino rabbit eyes

8 8 Automated Needleless Injector Lab Prototype

9 Injection of a Dye in Enucleated Rabbit Eyes using an Automated Needleless Injector 9 Pressure Injection time Energy Number of injections (psi) (s) (J) Intravitreal Subconjunctival Wet

10 Automated Needleless Injector Conclusions 10 Intravitreal and subconjunctival injection can be achieved with a needleless jet injector using pressures higher than with a jet injector equipped with a microneedle Intravitreal jet injection can be achieved reproducibly with a needleless jet injector using pressure of about 1000 psi Subconjunctival jet injection can be achieved reproducibly with a needleless jet injector using intermediate pressures ( psi)

11 11 Automated Needleless Injector Intellectual Property Issued US Patent 8,430,862 protects the use of an automated needleless injector device equipped with a positioning platform for subconjunctival injection

12 12 Automated Needleless 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.

13 13 Automated Needleless 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. U.S. Population Data Disease Prevalence (million) Incidence (000 per year) Growth Rate (% per year) Advanced Age-related Macular Degeneration 1.8 a 240 d 1.6 d Diabetic Macular Edema 1.5 b 190 e 5 e Central Retinal Vein Occlusion 1.5 c 95 f TBD a b CMRO, 26, 1587, 2010 c Arch Ophthalmol 126, 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

14 14 Automated Needleless Injector Drug Device Potential Rights for US 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.

15 KMG PHARMA LLC An expert ophthalmic incubator company