Synthetic corneas prove successful

An experimental synthetic cornea implanted in 10 patients may be a potential alternative to cadaver corneas for curing vision loss due to corneal inflammation and scarring, researchers said Wednesday.

Eye surgeons currently use primarily cadaver corneas for transplants, but that requires the use of anti-rejection drugs and presents a risk of infection. Plastic corneas can also be used, but they present other problems and are generally tried only when tissue transplants have failed.

The new artificial corneas use collagen produced in yeast as a scaffolding that allows cells from the recipient to grow into the graft so that it mimics the original tissue. The two-year preliminary test showed that the biosynthetic corneas restored vision as effectively as cadaver corneas, did not require anti-rejection drugs and allowed normal tears to form.

"This is a huge breakthrough," said Dr. Francis W. Price Jr., founder and president of the board of the Cornea Research Foundation, who was not involved in the research. "It still has to go through additional studies … but it shows a lot of promise."

The new study, reported Wednesday in the journal Science Translational Medicine, used biosynthetic collagen produced by FibroGen Inc. of San Francisco. A team headed by Dr. May Griffith of the Ottawa Hospital Research Institute in Canada molded the collagen into an artificial cornea and demonstrated that it worked in animals.

FibroGen, Inc., today announced that its investigational oral anemia therapy, FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People's Republic of China. FG-4592 is a first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) entering Phase 2b clinical development in the US and Europe for the treatment of CKD anemia. SFDA approved protocols for both Phase 1 and 2 studies. The first of these studies of FG-4592 in China will begin in the fourth quarter of 2010.

“This is a significant milestone in the global expansion of our development program for FG-4592,” said Thomas B. Neff, CEO of FibroGen. “With the support of SFDA, we are committed to bringing safe, effective and accessible oral anemia therapy to the people of China.”