pSivida Corp. announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF production and protected retinal cells and function. These findings support expanding the treatment indications for the company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is licensed to Alimera Sciences, of Alpharetta, Georgia and is in Phase III clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of the year, with an NDA filing scheduled for early 2010.
The results of these two studies, showed for the first time that FA acted as both a VEGF (vascular endothelial growth factor) inhibitor as well as a neuroprotective, explained Dr. Ashton, CEO of pSivida and a co-author of these papers. These properties support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase II trials are currently underway; and other degenerative conditions such as retinitis pigmentosa. Dr. Ashton noted that no currently approved treatment for these conditions provide both VEGF inhibitive and neuroprotective qualities.
The first study, Fluocinolone inhibits VEGF expression via glucocorticoid receptor in human retinal pigment epithelial (ARPE-19) cells and TNF-alpha-induced angiogenesis in chick chorioallantoic membrane (CAM) was published in the April . In the paper, Dr. Ashton, and colleagues Surya P. Ayalasomayajula and Uday B. Kompella, of the University of Nebraska Medical Center in Omaha, reported that they found that Fluocinolone inhibited VEGF expression in ARPE-19 cells via its glucorcorticoid receptor activity. In addition, flucinolone inhibited proliferation of ARPE-19 cells and TNF-a-induced angiogenesis in chorioallantoic membranes. VEGF inhibition is one method of treating wet-AMD and is the mechanism of action for currently the most effective FDAapproved treatment for this disease, said Dr. Ashton.
The second study, Photoreceptor neuroprotection in RCS rats via low-dose intravitreal
sustained-delivery of flucinolone acetonide studied the neuroprotective effects of FA delivered through a Medidur-device in RCS. Authors Dr. Ashton and Inna V. Glybina, Alexander Kennedy, Gary Abrams and Raymond Iezzi, of the Kresge Eye Institute in Detroit, found that chronic intravitreal infusion of FA preserves both the structure of the retina and retinal function. These findings suggest Iluvien may have a therapeutic role in human degenerative eye diseases including dry-AMD and retinitis pigmentosa.