Visiogen is reporting significant progress in the development of the Synchrony IOL, including the completion of the US phase III study, the formation of Visiogen Europe GmbH and the commencement of commercialization in Europe. Furthermore, a number of clinical investigators have published encouraging results from multiple comparative randomized double-masked trials as well as objective proof of mechanism of accommodation at up to five years. $40 million of equity finance raised recently should help secure the global commercialization of the Synchrony IOL.
The proprietary Synchrony accommodating IOL is intended for use in cataract and refractive patients and has a mechanism of accommodation that has been validated in multiple studies by multiple objective measures. The Synchrony lens is supplied in a proprietary pre-loaded injector to facilitate ease of implantation and to eliminate lens handling. The lens has been implanted in over 1,000 patients to date, and is the subject of multiple comparative clinical studies in the U.S., Europe and South America. Visiogen has completed its U.S. IDE study and will submit the results to the FDA in 2009, with premarket approval (PMA) anticipated in 2010.
"The funds we have raised will give us the flexibility and resources necessary to maximize the commercial impact of the Synchrony IOL," said Reza Zadno, CEO and Founder of Visiogen, Inc. "Our ability to raise capital from world-class investors in the current difficult economic climate is a testament to the significant market opportunity that exists for a next-generation accommodating IOL," Zadno added.
"We are excited at the opportunity to collaborate with Visiogen," said Steven Weinstein, managing director of the Novartis Venture Fund. "Their commitment to clinical science is impressive, as evidenced by their significant investment in clinically rigorous, double-masked, long-term trials of the Synchrony lens."