Latest data will be submitted to FDA as requested in CRL issued in December 2010.
pSivida and its licensee Alimera Sciences reported positive three-year data from the two-trial Phase III FAME® program evaluating Iluvien® for the treatment of diabetic macular edema (DME). Iluvien is an extended-release intravitreal insert designed to release submicrogram levels of fluocinolon acetonide (FA). A low-dose formulation of the product was filed with FDA back in June 2010, based on two-year data from FAME. However, in December 2010 FDA issued Alimera a Complete Response Letter stating it couldn’t consider approving the treatment until it had assessed the full 36-month safety and efficacy data package.
The firms now report that the 36-month results from both FAME studies confirm that treatment using the Iluvien insert continues to provide improvements in visual acuity over the whole three years. These results will be submitted to FDA by Alimera in support of the existing NDA filing. If approved, pSivida will be eligible for a $25 million milestone payment from Alimera, and 20% of profits on sales of the product.
Overall results from the two FAME studies demonstrated that patients receiving low-dose Iluvien exhibited benefits in visual acuity as early as week three, and this effect was maintained throughout the 36 months. On a combined basis, 28.7% of Iluvien patients demonstrated best corrected visual acuity (BCVA) improvements of 15 letters or more from baseline at 24 months, compared with 16.2% of controls. At 30 months the figures were 31.4% of Iluvien patients and 15.1% of control patients. At 36 months, 28.7% of Iluvien patients and 18.9% of control patients had a BCVA of 15 letters or more over baseline. “This consistent response rate at month 24 and month 36, with a peak rate of 31.4% at month 30, is encouraging, and we believe demonstrates Iluvien can provide a long-term option for the treatment of DME for up to three years,” comments Dan Myers, president and CEO at Alimera.