Implant shows promise for treatment of DME, DR

SAN FRANCISCO — An intravitreal implant for the treatment of diabetic macular edema has shown a statistically significant reduction in macular edema, according to results from a phase 3 trial.

The implant also showed a reduction in the severity of diabetic retinopathy. P. Andrew Pearson, MD, and colleagues reported here during the Retina Congress 2002 on results from an 80-patient clinical trial using an intravitreal fluocinolone acetonide implant. The implant uses proprietary Envision TD technology, which delivers the drug via a reservoir inserted into the back of the eye.

According to Bausch & Lomb, the technology’s developer, the drug may be delivered for up to 3 years. Earlier this year, initial results from the study indicated that patients receiving the implant showed a statistically significant reduction in both DME and diabetic retinopathy as assessed by retinal thickening. A greater proportion of patients with the implant also showed improved or stabilized visual acuity when compared with the standard of care. For the purposes of this study, standard of care was defined as macular grid laser surgery or observation.

According to Dr. Pearson, 36.8% of the patients treated with the 0.5-mg implant improved more than two grades as measured by fundus photographs. Fellow eye comparisons showed a statistically significant difference in retinal thickness for the implanted vs. fellow eye. Dr. Pearson added 37% of patients with the implant demonstrated one unit or greater improvement in their retinopathy scores compared with 15% in the standard of care group.