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An in vitro model for screening penetration of ocular drug products

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43EY034422-01
Agency Tracking Number: R43EY034422
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NEI
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-01
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Huntsville, AL 35806-2923
United States
DUNS: 185169620
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (256) 726-4500
Business Contact
Phone: (256) 361-0817
Research Institution

Project Summary/Abstract:
The overall objective of this study is to develop a novel, predictive in vitro platform for studying physiological
responses of the cellular layers of the anterior eye for therapeutics. Current in vitro models mostly rely on a single
cellular architecture of the corneal epithelium and do not mimic the in vivo physiological relevance of cell-cell
and cell-ECM interactions. In addition, they lack the capability for real-time visualization and quantitation of
cellular interactions. Animal models do not accurately represent the anatomy and physiology of the human eye.
We propose to develop and demonstrate a microfluidic-based multicellular architecture of the human cornea
based on in vivo morphological and structural parameters. Phase I will culminate with a clear demonstration on
the ability of the model to match drug penetration profiles with detailed functional characterization of the cellular
interactions and matrix development. During Phase II, we will expand the platform to incorporate additional tissue
layers such as the conjunctiva and integration with well plates for a multiplexed assay followed by further
validation against in vivo studies. A multi-disciplinary, partnership with expertise in microfluidic cell-based
assays, eye physiology and therapeutic screening with clinical relevance has been assembled to successfully
meet the research objectives. The end-product will be commercialized to pharmaceutical firms, drug research
labs and universities/non-profit centers engaged in precision therapeutics, drug discovery, and drug delivery in
the ophthalmic space.

* Information listed above is at the time of submission. *

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