You are here

Antifungal-containing Solution for Corneal Tissue Storage and Transport

Description:

Fast-Track proposals will not be accepted.
Number of anticipated awards: 1
Budget (total costs):
Phase I: up to $150,000 for up to 12 months
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Background
Endophthalmitis is a rare, but severe infectious complication of corneal transplant surgery (keratoplasty) that requires prolonged treatment with intraocular antimicrobial drugs and results in vision loss for over half of patients. Post-keratoplasty endophthalmitis incidence has more than doubled from 2007 to 2014 according to adverse event surveillance conducted by the Eye Bank Association of America, and fungi (primarily Candida yeast) caused the majority of cases. Moreover, the proportion of post-keratoplasty fungal endophthalmitis is increasing and CDC has received several recent reports of fungal endophthalmitis clusters associated with corneal tissue banks and corneal surgery centers. The predominant Candida yeast etiology among post-keratoplasty fungal endophthalmitis cases suggests that donor skin and gastrointestinal flora are a possible source of contamination, and that corneal tissue handling and storage after donor extraction might allow transmission of fungal contaminants to recipients. Currently, the main corneal tissue storage and transport solution used in the United States does not contain an antifungal drug, and may provide a permissive environment for donor contaminant fungi to grow.
Project Goals
The specific research aim is to develop a liquid solution for corneal tissue storage and transport that contains an antifungal drug that inhibits growth of contaminant fungi for at least 14 days following donor tissue extraction. The solution must be usable in compliance with current corneal tissue storage, evaluation and transport procedure guidance and regulations.
Phase I Activities and Expected Deliverables
The primary activity is formulation of a liquid solution that serves the purpose of currently available products, and that contains an effective antifungal that is safe for use and non-damaging to corneal tissue.
Monthly Deliverables:
 Assemble list of viable antifungals (e.g., Amphotericin B) and design in vitro and in vivo studies to
demonstrate effectiveness against Candida and other fungi, optimize antifungal concentration, and
demonstrate that the product does not adversely affect corneal tissue quality and health.
 Present preliminary data on efficacy and safety, showing effective antifungal properties without compromise
of corneal tissue health and quality.
 Present data supporting optimized antifungal and ingredient concentrations, and advanced evidence of
product suitability for further development and ultimate regulatory evaluation.

Impact
A corneal storage and transport solution containing safe and effective antifungals could reduce morbidity, vision loss and healthcare expenditures due to post-keratoplasty fungal endophthalmitis, and could reduce the recent increase in fungal endophthalmitis incidence. Previously, a product currently on the market was reformulated to include antibiotics effective against bacteria, and surveillance data indicated a subsequent decrease in bacterial endophthalmitis although causality was not established. We speculate that adding an antifungal may result in similar effects for fungal endophthalmitis, preventing these devastating and sight-threatening eye infections. We expect many stakeholders will benefit from this product going to market. Eye banks, which harvest donor corneas where contamination might occur, will have an added layer of security by storing tissue in antifungal-containing media immediately after harvest, which will prevent pathogenic fungi from growing. In addition, the Eye Bank Association of America, which collects and reports on adverse events linked to corneal transplants, has been advocating for a product like this for several years in an effort to reduce the increasing trend in fungal endophthalmitis. Finally, this product would be a straightforward win for a small business; corneal storage solution is universally used and required by those who work with and transplant corneal tissue and the urgent need for reduced risk of fungal contamination during the corneal harvest-storage-transplant process is currently unmet by any other product on the market.
Commercialization Potential
Successfully developed and marketed to surgeons, this product will have significant commercial potential as there is currently no similar competing product available to corneal surgeons in the United States. The primary target market for this product will be corneal surgeons who perform corneal transplants (keratoplasties), as well as eye banks who procure corneal storage media and must respond to the demands of their clients (corneal surgeons).

US Flag An Official Website of the United States Government