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Diabetic Macular Edema
February 22, 2010
Regeneron and Bayer released positive results from a phase II trial of VEGF Trap-Eye for diabetic macular edema (DME). This double-blind, randomized, multi-center trial, DA VINCI (DME And VEGF Trap-Eye: INvestigation of Clinical Impact), enrolled 219 subjects with clinically significant DME with central macular involvement. The subjects were randomized to five groups. The control group received standard of care, macular laser therapy, at week one and were eligible for repeat laser treatments, but only at 16 week intervals. Two groups received monthly doses of 0.5 or 2.0 mg of VEGF Trap-Eye throughout a six-month dosing period. Two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks four and eight), followed through week 24 by dosing either every eight weeks or as-needed, with specific repeat dosing criteria. The primary endpoint was a statistically significant improvement in visual acuity over 24 weeks compared to the standard of care. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study. Each of the four VEGF Trap-Eye dosing groups achieved statistically significantly greater mean improvements in visual acuity (8.5 to 11.4 letters of vision gained) compared to subjects receiving macular laser therapy (2.5 letters gained) at week 24 (p< 0.01 for each VEGF Trap-Eye group versus laser). VEGF Trap-Eye was generally well tolerated, and there were no drug-related serious adverse events.
January 11, 2010
Alimera and pSivida issued positive results from two phase III trials of Iluvien, an intravitreal insert for the treatment of diabetic macular edema. These identical multi-center, randomized, double-masked trials, dubbed FAME, enrolled 953 subjects across the United States, Canada, Europe and India. The subjects were placed in one of three groups: high dose Iluvien (an approximate initial 0.45 micrograms per day dose), low dose of Iluvien (an approximate initial 0.23 micrograms per day dose) and placebo. The primary efficacy endpoint was the difference in the percentage of subjects whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and placebo groups. The first trial demonstrated statistical significance with 26.8% (p≡0.029) of the low dose group and 26.0% (p≡0.034) of the high dose group reaching the primary endpoint. The second trial also demonstrated statistical significance at 24 months, with 30.6% (p≡0.030) of the low dose group and 31.2% (p≡0.027) of the high dose group having an improvement in BCVA of 15 letters or greater from baseline. Treatment was generally well tolerated; intraocular pressure was the most commonly reported endpoint.