One company that is starting to earn attention within the pharmaceutical sector is Alimera Sciences, Inc. Located in Alpharetta, Georgia, Alimera is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Today, Alimera took a major step towards enhancing its future with the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien.
Iluvien is Alimera’s investigational sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 2010.
Leading the team at Alimera is Dan Myers who serves as the company’s president and CEO. When asked what this NDA meant to the future of Alimera, Myers was quoted as saying, “This is a significant milestone for all of us at Alimera, and represents a major advance toward a rapid and sustained visual acuity benefit for DME sufferers. We believe that Iluvien(R), if approved, will provide a needed alternative to the multiple injections of corticosteroids and anti-VEGF therapies used off-label for extended efficacy in DME. We believe this would be the first ophthalmic drug therapy to be approved for DME and the only DME treatment that works in terms of years, not months.”
Alimera is currently conducting two Phase 3 pivotal clinical trials which are known as the FAME Study. The study for Iluvien will involve 956 patients in sites across the United States, Europe, Canada and India and will allow Alimera to access the safety of Lluvien for the treatment of DME with both high and low doses.
To learn more about Alimera, visit the company website at: www.alimerasciences.com.