Alimera Sciences has released data from the first head-to-head clinical trial comparing its Iluvien implant (fluocinolone acetonide 0.19 mg) to anti-VEGF therapy in patients with early diabetic macular edema (DME), showing that Iluvien achieved similar visual outcomes while cutting the number of injections by more than half.

The results from the NEW DAY trial were presented at the Euretina Innovation Spotlight in Paris by Charles Wykoff, MD, of Retina Consultants of Texas. The phase 4 study enrolled 306 eyes across 42 centers in the United States and followed patients for 18 months, assessing efficacy, safety, and treatment burden. Patients were randomized to receive either a single Iluvien implant followed by supplemental aflibercept 2 mg (Eylea; Regeneron) as needed, or aflibercept loading doses with continued supplemental dosing as required. The Iluvien group required an average of 3.4 total injections over 18 months, compared with 7.5 in the aflibercept-only group. One-third of patients in the Iluvien arm required no supplemental injections. The trial also found that the mean time from last injection to the first supplemental injection was significantly longer with Iluvien (185.4 days vs 132.8 days).

Researchers said the findings support earlier use of long-acting corticosteroid implants in the DME treatment pathway.