Isotechnika's lead drug, ISA247, receives fast track designation from FDA for the treatment of uveitis

09-Aug-2007

Isotechnika announced that the food and Drug Administration (FDA) of the United States granted fast track designation for the Company's lead drug, ISA247 under section 506 of the Federal Food, Drug and Cosmetic Act. The FDA based its decision on the following reasons: ISA247 is intended for the treatment of a serious or life-threatening condition, namely non-infectious posterior, intermediate and panuveitis, and ISA247 demonstrates the potential to address medical needs unmet by available treatments for non-infectious posterior, intermediate and panuveitis.

"Thanks to the FDA's approval for Fast-Track designation, we have the potential to more rapidly deliver to patients a much needed drug for uveitis," comments Ulrich Grau, PhD, president and chief executive officer of Lux Biosciences. "If successful, LX211 (referred to as ISA247 by Isotechnika) would be the first thoroughly tested and approved steroid-sparing therapy for the treatment of uveitis."

Lux Biosciences began enrolling patients in pivotal clinical trials for ISA247 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. Enrollment for the LUMINATE trial program is expected to be completed by early 2008 and, if successful, Lux plans to seek regulatory approval for LX211 in late 2008. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis.

https://www.bionity.com/en/news/66925/isotechnika-s-lead-drug-isa247-receives-fast-track-designation-from-fda-for-the-treatment-of-uveitis.html