INTRACORNEAL LENS FOR THE CORRECTION OF HYPEROPIA

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44EY013031-02
Agency Tracking Number: EY013031
Amount: $1,444,100.00
Phase: Phase II
Program: SBIR
Awards Year: 2002
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
ANAMED, INC.
ANAMED, INC., 7700 IRVINE CENTER DR, STE 800, IRVINE, CA, 92610
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 ALOK NIGAM
 (949) 707-2740
 ALOKN@ANAMEDINC.COM
Business Contact
 ALOK NIGAM
Phone: (714) 753-2845
Email: ALOKN@ANAMEDINC.COM
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): 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.

* information listed above is at the time of submission.

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