RESPOND study: Iluvien effective at 6 months in DME patients
Iluvien was effective and well tolerated in reducing retinal thickness and improving visual acuity in patients with chronic diabetic macular edema, Alimera Sciences announced in a press release.
Alimera Sciences Limited, the company’s European subsidiary, announced the interim 6-month results of the RESPOND study at the Euretina congress in Nice, France.
The nonrandomized, open-label, multicenter phase 4 pilot study is focusing on the efficacy and safety of Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) in patients with chronic DME that is insufficiently responsive to available therapies. The study is being conducted at four sites in Portugal.
Twelve patients received a single injection of Iluvien. Eleven patients completed 6 months of follow-up, and nine of those patients had maintained or improved best corrected visual acuity compared with baseline. Central subfield thickness decreased in 10 patients. BCVA improved an average of 7.1 letters in the 11 patients, with an average decrease in central subfield thickness of 300.6 µm, according to the release.
Patients will be followed out to 12 months, and IOP increases and cataract progression will also be monitored.