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Sustained Ocular Drug Delivery System for Anti-VEGF Agents

Award Number: R01EY029298
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Sustained Ocular Drug Delivery System for Anti-VEGF Agents - Project Summary Recently employed intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is a promising treatment for the wet form of age-related macular degeneration with choroidal neovascularization (CNV) and diabetic retinopathy. In fact, the anti-VEGF therapy has become a gold standard for these diseases. While the therapeutic effects are positive, a major drawback is that this treatment must be repeated every four to six weeks. The repetitive treatment burden on the patients, family members, and clinicians is substantial. Recently, we have developed a biodegradable microspheres, thermo-responsive hydrogel ocular drug delivery system (DDS). Biodegradable microspheres are produced using our modified double emulsion technique providing a better microenvironment for pharmacological agents. The biodegradable thermo-responsive hydrogel is a safe, effective, and injectable biomaterial that is used to confine the microspheres to a specific delivery site. We have previously demonstrated a controlled sustained release of anti-VEGF for a period of 6 months with excellent safety profiles. The overall goal of this proposal is to quantitatively evaluate the safety and efficacy of our proposed DDS in a non-human primate model and compare to the conventional therapy. Our hypothesis is that a sustained controlled anti-VEGF release over a prolong period of ~6 months, will be as effective, if not more effective, as the conventional therapy. The Specific Aim 1 is to determine ocular pharmacokinetics (PK) of aflibercept released from DDS in a non-human primate (NHP) model. The Specific Aim 2 to determine biocompatibility of DDS in a NHP model. The Specific Aim 3 is to quantitatively compare the efficacy and bioactivity of the proposed DDS to the conventional therapy in its ability to suppress angiogenic responses in CNV model. The Specific Aim 4 is to measure long-term potential side effects, if any, of the proposed DDS and exposure of anti-VEGF in a rodent model. The Specific Aim 5 is to quantitatively evaluate the drug release kinetics and bioactivity of the dual-drug release DDS. Widespread clinical use of anti-VEGF necessitates a practical and effective delivery method to the posterior segment of the eye. We believe that our drug delivery system will fill this critical clinical need. The knowledge gained in this proposal will bring this technology one step closer to translation into the clinical practice and will have a significant impact on the current healthcare system.


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: 2025 ( Subtotal = $0 )
2025	2023	THE TRUSTEES OF THE STEVENS INSTITUTE OF TECHNOLOGY	ONE CASTLE POINT ON HUDSON	HOBOKEN	NJ	07030	HUDSON	USA	Vision Research	000	6	3/7/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $257,400 )
2023	2023	STEVENS INSTITUTE OF TECHNOLOGY (INC)	1 CASTLE POINT ON HUDSON	HOBOKEN	NJ	07030	HUDSON	USA	Vision Research	001	6	2/13/2023	NON-COMPETING CONTINUATION	$257,400
2023	2022	THE TRUSTEES OF THE STEVENS INSTITUTE OF TECHNOLOGY	1 CASTLEPOINT ON HUDSON	HOBOKEN	NJ	07030	HUDSON	USA	Vision Research	005	5	5/20/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$87,796
2023	2022	STEVENS INSTITUTE OF TECHNOLOGY (INC)	1 CASTLE POINT ON HUDSON	HOBOKEN	NJ	07030	HUDSON	USA	Vision Research	000	5	12/1/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2022	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	004	4	5/20/2023	NON-COMPETING CONTINUATION	-$24,999
2023	2021	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	002	3	5/20/2023	NON-COMPETING CONTINUATION	-$57,643
2023	2021	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	003	3	5/20/2023	SUPPLEMENT FOR EXPANSION	-$5,154
														Subtotal = $257,400

Issue Date FY: 2022 ( Subtotal = $586,277 )
2022	2022	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	001	4	9/21/2022	NON-COMPETING CONTINUATION	-$561,279
2022	2022	STEVENS INSTITUTE OF TECHNOLOGY (INC)	1 CASTLE POINT ON HUDSON	HOBOKEN	NJ	07030	HUDSON	USA	Vision Research	002	5	9/21/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$561,278
2022	2022	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	000	4	4/11/2022	NON-COMPETING CONTINUATION	$586,278
														Subtotal = $586,277

Issue Date FY: 2021 ( Subtotal = $636,596 )
2021	2021	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Vision Research	001	3	9/15/2021	SUPPLEMENT FOR EXPANSION	$52,250
2021	2021	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH STREET	CHICAGO	IL	60616	COOK	USA	Vision Research	000	3	3/3/2021	NON-COMPETING CONTINUATION	$584,346
														Subtotal = $636,596

Issue Date FY: 2020 ( Subtotal = $624,845 )
2020	2020	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH STREET	CHICAGO	IL	60616	COOK	USA	Vision Research	000	2	3/12/2020	NON-COMPETING CONTINUATION	$624,845
														Subtotal = $624,845

Issue Date FY: 2019 ( Subtotal = $637,967 )
2019	2019	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH STREET	CHICAGO	IL	60616	COOK	USA	Vision Research	000	1	4/18/2019	NEW	$637,967
														Subtotal = $637,967

Grand Total All Awards = $2,743,085

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Sustained Ocular Drug Delivery System for Anti-VEGF Agents

Award Number: R01EY029298

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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