FDA Fast Tracks DRY Macular Degenerations Drug Test

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd.,announced that they have received Fast Track designation from the US Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD). The FDA’s Fast Track programmes are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated programs may be eligible for priority regulatory review by the FDA.

ACU-4429 is administered to patients as an oral, daily pill rather than by injection into the eye, which is typical of many current eye therapeutics.

http://www.pharmabiz.com/article/detnews.asp?articleid=54608

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