Fluocinolone Acetonide Approved for Diabetic Macular Edema


Fluocinolone AcetonideAs the leading cause of blindness in the United States Diabetic Macular Edema {DME} is a serious concern for the growing aging population, affecting roughly one million Americans. The recent announcement from pSivida Corp. regarding the marketing authorization in the EU of their DME treatment Fluocinolone is hopeful for U.S. supporters of this formidable drug. Known as the brand name Iluvien, Fluocinolone gleaned marketing authorizations in the United Kingdom, Spain, France, Germany, Austria, Italy and Portugal at the end of June 2014. Numerous studies of this effectual corticosteroid have demonstrated positive results for the treatment of ocular diseases.

What is DME

A successful global study of Fluocinolone Acetonide, coined FAME {Fluocinolone Acetonide in Diabetic Macular Edema}, involved two comprehensive multi-center trials. A total of 956 patients from the United States, India, Canada and Europe were enrolled in the trials, and these studies were both masked and randomized. As a three year study data will still be gathered and analyzed, however, 24 month data has proven the efficacy of Fluocinolone with top line results revealing primary study goals are being met. Patients involved in the studies thus far received one of two doses of Fluocinolone of approximately 0.45 micrograms (µg) per day or exactly 0.23 µg per day. Patients received Fluocinolone Acetonide as an injection, which is designed to be effective for up to three years. The injection is done via the back of the eye with a 25 gauge needle which creates a self-sealing hole, similar to intravitreal injection, which is a common procedure done by retinal specialists.

Diabetic Macular Edema occurs most often in patients who have diabetic retinopathy. Damaged blood vessels in the eye leak fluid into the macula, causing swelling with blurry vision. Clinical presentation of DME often includes a retinal thickening within 500 µm of the center of the fovea and at least 1 disc area of retinal thickening. The need for timely treatments for patients with DME is imperative, with research and development teams actively seeking safe and novel medications.

LGM Pharma is a provider of Fluocinolone Acetonide, CAS # 67-73-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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