The
ASP5354 is an optical imaging agent being developed by Astellas' Rx+ business1 as a surgical adjunct to lessen the likelihood of iatrogenic ureteral injury (IUI) during complex abdominal and pelvic surgeries such as colorectal or gynecologic surgeries. IUI can result in long-term complications such as ureteral stricture / obstruction, ureteral-vaginal fistulae, acute or chronic renal failure, or sepsis. A survey of more than 2 million surgical cases in the
ASP5354 is a derivative of indocyanine green (ICG) that fluoresces upon excitation with a particular wavelength of near-infrared light. When administered intravenously, ASP5354 is primarily and rapidly excreted by the kidneys and provides the surgeon with visualization of the ureter(s) during surgery through the use of a near-infrared fluorescence (NIR-F) medical device. ASP5354 is an investigational compound discovered by
In the Phase 1 study ASP5354 was safe and well tolerated at all doses evaluated in healthy volunteers. A Phase 2 study is currently underway to evaluate the safety and efficacy of ASP5354 in patients undergoing colorectal surgery.
Through its Rx+ business, Astellas aims to realize a society where people can live in their own way, both physically and mentally through scientifically based healthcare solutions. Through this venture, Astellas aims to optimize treatment by improving diagnostic accuracy and surgical outcomes. The development of ASP5354 for precision surgery is part of this effort. Going forward, Astellas looks forward to providing various solutions that contribute to more precise and safer surgical methods through the fusion of medical device innovation and pharmaceutical technology.
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In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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