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Biosynthetic corneas formulated with recombinant collagen restore vision and nerve growth
Date:8/25/2010

mote tissue regrowth and restore vision."

"These clinical results suggest that our collagen could potentially provide an important option for patients by reducing risk of disease transmission and increasing supply of corneal implant material in the face of the worldwide shortage of human donor corneas," said Thomas B. Neff, Chief Executive Officer of FibroGen. "This product concept continues to be improved and additional studies are planned."

About the Phase 1 Study

In the clinical study, 10 patients with corneal disease underwent resection, followed by surgical implantation with rhCIII-based biosynthetic corneas. Two-year post-surgery results demonstrated that 100% of the transplanted corneas remain viable at two years, cells from the patients' own corneas had grown into the implant, and nerves that had been severed during surgery regrew. In addition, the blink reflex and tear film were restored. In terms of visual acuity, at 24 months, best spectacle-corrected visual acuity improved in six patients, remained unchanged in two patients and decreased in two. None of the patients experienced any rejection reaction or required long-term immunosuppressive therapy, serious issues associated with the use of human donor tissue.

Unmet medical need for a biosynthetic corneal implant

Loss of vision due to corneal disease or trauma affects over 10 million individuals worldwide, but lack of access to good quality donor tissue severely limits the number of transplant procedures that can be done, particularly in the developing world. In the US, an estimated 42,000 corneal grafts are performed annually using optical tissue from cadavers; however, graft rejection can occur, and failure rates are significant. In addition, the mandatory use of steroids with cadaver-sourced corneal material limits their successful use to certain patient populations. Fully synthetic prostheses (without biological activity) have been developed, but t
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Contact: Laura Hansen
lhansen@fibrogen.com
415-978-1433
FibroGen, Inc.
Source:Eurekalert

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