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Small Incision Artificial Cornea

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44EY021664-02
Agency Tracking Number: R44EY021664
Amount: $1,425,133.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NEI
Solicitation Number: PA10-050
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): 2018-09-29
Small Business Information
1270 Lawrence Station
Sunnyvale, CA 94089-
United States
DUNS: 186952748
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (408) 887-4856
Business Contact
Phone: (408) 887-4856
Research Institution

DESCRIPTION (provided by applicant): The objective of this grant proposal is to perform a clinical study which will allow the first foldable and injectable artificial cornea, the KeraKlear, to be used in the United States market for treatment of corneal blindness. This device may be implanted through an incision size that is approximately 1/10th the size of the incision that is required for the most popular artificial cornea available in the U.S. The smaller incision size is expected to allow a much quickersurgery for patients and a more accelerated recovery as compared to the currently available artificial corneas. In addition, the KeraKlear artificial cornea may be implanted in many patients with cornea blindness without penetration into the anterior chamber. This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye (endophthalmitis) and severe bleeding (expulsive hemorrhage). The use of the KeraKlear artificial cornea also avoids the commoncomplications of corneal transplantation including high astigmatism, corneal graft failure and corneal graft rejection. Finally, the KeraKlear would enable the treatment of cornea blindness in a much larger number of patients. Currently, corneal transplantation is limited to about 100,000 per year worldwide because of the lack of suitable donor corneas. This represents only 1% of the 10 million people worldwide who have cornea blindness in both eyes. By making the KeraKlear artificial cornea available a significantly larger percentage of the cornea blind patients around the world could be treated. PUBLIC HEALTH RELEVANCE A new type of foldable and injectable artificial cornea has been developed for placement through a small incision (3 mm). In thisproject, we will perform clinical studies to determine the safety and efficacy of this new device. Successful completion of the study will lead to the availability of this less invasive artificial to cornea blind patients in the U.S.

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

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