The first phase of this SBIR project focused on demonstrating the feasibility of a delivery vehicle for topically applied anti-infectives to achieve extended duration of pharmacologically active drug concentrations in the tear film, cornea, and conjunctiva. During this phase of the investigation, a tobramycin formulation (TobraSite) using InSite's proprietary insoluble polymer vehicle (DuraSiteTM) was developed that had similar bioavailability to a marketed tobramycin ointment product, TobrexR. The second phase of this SBIR project has two major objectives. One focuses on optimization of the formulation of ophthalmic use by addition of other components or manipulation of the physico-chemical parameters. The formulations that prove to be most beneficial in terms of product stability, safety, and efficacy will then be tested for safety in studies on animals. The second objective focuses on studies of the safety and efficacy of the primary formulation in humans.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44EY008784-03
Application #
2162481
Study Section
Visual Sciences A Study Section (VISA)
Project Start
1990-09-30
Project End
1994-08-31
Budget Start
1993-09-01
Budget End
1994-08-31
Support Year
3
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Insite Vision, Inc.
Department
Type
DUNS #
City
Alameda
State
CA
Country
United States
Zip Code
94501