CorneaGen -Amphotericin B

Our work, along with recent published work, discovered that corneas can be safely stored in corneal storage media containing Amphotericin B for up to two weeks at a dose of 4 µg/ml or lower.

Evidence supports that a concentration of 2.5 µg/ml of Amphotericin B in corneal storage media to be the best balance between safety and efficacy.

Investigations sponsored by the Eye Bank Associations of America have reported an increase in the incident of graft transmitted fungal infections from its member eye banks than observed in previous years.

The Candida species of fungus has been shown in serval studies to be the most common fungal species isolated from these infections. Amphotericin B has shown to be highly efficacious and long lasting when compared to other antifungals. For 40 years Ampho B has been known as the “gold standard” for treating invasive fungal infections by physicians.

• 40% of European eye banks use a storage media that contains Ampho B at a 0.255 µg/ml concentration.
• Previous studies have shown the 0.255 µg/ml concentration to eliminate a starting inoculum infection of 2.5 x 10 103 colony forming units of Candia within 48 hours of cold storage.
• While results with the 0.255 µg/ml concentration have been encouraging, efficacy against higher inoculum sizes or shorter exposures times could not be determined.
• CorneaGen initiated studies to improve the efficacy of our Amphotericin B offering.
• CorneaGen has decided to increase the concentration from 0.255 µg/ml to 2.50 µg/ml. Study results have shown it to be safe and highly effective.

29 Scientific Publications Referenced19 peer-reviewed scientific publications were primary references for:

• Efficacy
• Safety
• Shelf life
• Case studies
• Infection treatment profiles

10 peer-reviewed scientific publications were secondary references for:

• Toxicity of topical antifungal agents
• Empirical therapy for invasive fungal infections
• Warm versus cold storage
• Safety of Moxifloxacin and Voriconazole in corneal storage media
• Test conditions on antifungal time-kill curve results