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NOVEL METHOD FOR THE OCULAR IONTOPHORETIC DELIVERY OF AVASTIN AND LUCENTIS

Award Number: R43EY020791
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2010
PERIOD OF PERFORMANCE END DATE: 06/30/2011

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NOVEL METHOD FOR THE OCULAR IONTOPHORETIC DELIVERY OF AVASTIN AND LUCENTIS - DESCRIPTION (provided by applicant): Iontophoresis is a method of using a mild electrical current to enhance the penetration of a drug through tissue. Our long term goal is to develop the Visulex(r) ocular iontophoresis device capable of delivering large molecule anti-VEGF agents to the posterior segment of the eye: * A safe, noninvasive ocular drug delivery method, thereby improving patient compliance. * A system operated by nurses, paraprofessionals, or even patient themselves, making anti- VEGF therapy more accessible to AMD patients thereby improving vision and quality of life for a greater portion of our population. * Cost effective for our health c are system by minimizing the need for complicated procedures (i.e. laser or surgical procedures) handled by retinal specialists. * Dosing of anti-VEGF therapy can be adjusted by incorporating or varying iontophoresis parameters (e.g. current density or treatment duration); drug formulations (e.g. incorporation of electroosmosis enhancers); or electroporation methods. * Changing a treatment paradigm for AMD both in terms of addressing acute conditions and those borderline cases such as early stages of the dry form of AMD where only prevention treatment measures to inhibit AMD are warranted. * The risks associated with frequent treatments addressing chronic AMD therapy would be less than IVT injections. To achieve proof of concept of this goal, we will conduct this project under three specific aims: 1) To optimize the iontophoretic parameters for an ocular delivery system of both Avastin(r) and Lucentis(r) in vitro. 2) To study the pharmacokinetics and assess the local tolerance of the eye following iontophoretic administration of the drugs in vivo in rabbit. 3) To establish transscleral iontophoresis of Avastin(r) and Lucentis(r) for the treatment of choroidal neovascularization in a disease treatment model. PUBLIC HEALTH RELEVANCE: Our phase I business catalyst grant proposes to develop a non-invasive, topical ocular drug delivery system using a mild electrical current methodology allowing for a timely application procedure in the doctor's office of a device (resembling a scleral lens) which eventually can be performed by a nurse or paraprofessional. Age-related macular degeneration (AMD) is a leading cause of blindness in the United States. While anti-VEGF compounds Avastin(r) and Lucentis(r) are effective in the treatment of the wet (acute, sight threatening) form of AMD, they must be administered frequently by intravitreal (IVT) injections. IVT injections involve a number of serious risks including retinal detachment, endophthalmitis, increased IOP and cataractogenesis. Frequent intraocular injections are not patient friendly and burdens our health care system with expensive procedures as they also take up a great deal of time out of the schedules of retinal specialists who are limited in numbers in the United States (less than 2500).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2010 ( Subtotal = $214,000 )
2010	2010	ACIONT INC	350 WEST 800 NORTH	SALT LAKE CITY	UT	84103	SALT LAKE	USA	Trans-NIH Recovery Act Research Support	000	1	5/26/2010	NEW	$214,000
														Subtotal = $214,000

Grand Total All Awards = $214,000

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NOVEL METHOD FOR THE OCULAR IONTOPHORETIC DELIVERY OF AVASTIN AND LUCENTIS

Award Number: R43EY020791

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2010

PERIOD OF PERFORMANCE END DATE: 06/30/2011

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