Anamed has developed PermaVisionr intracorneal implants for the correction of refractive errors, specifically, hyperopia from +1D to +6D. These implants are made from a selected proprietary Nutraporer micro-porous hydrogel that allows transport of fluid and nutrients satisfying the needs of the human cornea. There is no permanent solution for hyperopia today. Implantation is done using a procedure to be called Sutureless Synthetic Keratophakia (SSKTM). This involves lamellar dissection to generate a flap (like in LASIK surgery), placing the lens on the stromal bed and closing the flap without sutures. Rehabilitation is quick. The power of the lens is predefined and pre-tested during manufacturing so the surgeon can accurately correct the power in one sitting. The procedure is reversible and adjustable. Improper power correction/lens placement can easily be corrected by re-lifting the flap and replacing/repositioning the lens. During Phase II we propose to develop final lens design(s), manufacture clinical supplies, conduct a Phase I clinical trial under an approved USFDA-IDE, develop commercial packaging and sterilization process, determine shelf life and photo-stability, select a marking material/method to confirm proper lens placement/orientation which was found difficult during the one year GLP swine study (completed), develop commercial manufacturing process(es), and perform validations.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44EY013031-02
Application #
6549370
Study Section
Special Emphasis Panel (ZRG1-SSS-R (10))
Program Officer
Fisher, Richard S
Project Start
2002-09-30
Project End
2004-08-31
Budget Start
2002-09-30
Budget End
2003-08-31
Support Year
2
Fiscal Year
2002
Total Cost
$984,000
Indirect Cost
Name
Anamed, Inc.
Department
Type
DUNS #
City
Lake Forest
State
CA
Country
United States
Zip Code
92630