Ampho B

CorneaGen offers surgeons the option of requesting Amphotericin B (Ampho B) additive to corneal storage media.
 

Background

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.
 

28 Scientific Publications Referenced

18 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
 

Research

Bennie H. Jeng, MD, along with CorneaGen co-investigators, performed scientific research projects regarding Ampho B safety.
  • The studies investigated the effect on endothelial cells of Ampho B at a concentration of 0.255 μg/mL in corneal storage media; they found that it was safe.
  • The studies corroborated published results.
 

Validations

Two separate process validations were performed.
  • The first validation demonstrated that Ampho B had a negligible effect to the corneal endothelial cells.
  • The second validation demonstrated that the process for adding Ampho B to the storage media had effective environmental controls with no detectable microbiological contamination.
 

Published References on Ampho B Safety and Efficacy (Partial List)

N. Layer, V. Cevallos, A. Maxwell, B. Jeng MD, Efficacy and Safety of Antifungal Additives in Optisol-GS Corneal Storage Medium. Article, May 2014, JAMA Ophthalmology.

K. Duncan, J. Parker, C. Hoover, B. Jeng, MD, The Effect of Light Exposure on the Efficacy and Safety of Amphotericin B in Corneal Storage Media. Article, May 2014, Jama Ophthalmology.

J. Deswal,S. K. Arya, Intracorneal Amphotericin B Injection in a Case of Indolent Candidal Keratitis. Article, May 2017, Journal of Clinical and Diagnostic Research. 

E. Garcia-Valenzuela, C. Diane Song, Intracorneal Injection of Amphotericin B for Recurrent Fungal Keratitis. Article, December 2005, Arch Ophthalmol.