A biodegradable intravitreal implant, the Brimonidine drug delivery system (Brimo DDS), had a “favorable safety profile” in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration, according to a study published in Retina. The drug-eluting device reduced GA lesion area growth at 3 months and at 12 months in patients with baseline GA lesion area that were at least 6 mm2.
These results support phase 3 development, the research says.
This study was the phase 2 stage, conducted as a randomized, multicenter, double-masked, 24-month study. Study eyes were treated (day 1; month 6 retreatment) as follows: with Brimo DDS 132 µg (n=49), Brimo DDS 264 µg (n=41), or sham procedure (n=23). Efficacy analysis was conducted with month 12 as the primary timepoint.
Researchers found that mean GA area growth at month 12 was 1.78 mm2, 1.59 mm2, and 2.19 mm2 in the Brimo DDS 132 µg, 264 µg, and sham groups, respectively.
“Geographic atrophy area growth was consistently smaller with Brimo DDS 132 µg and 264 µg than sham; between-group differences were significant (P ≤.032) at month 3,” the report shows. “In patients with baseline lesion area ≥6 mm2 (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 µg and 264 µg at Month 12 (P ≤.050 vs sham).”
Most treatment-related adverse events were injection procedure-related (16 in the 132 µg group), (10 in the 264 µg group), and sham group (2).
The study’s main limitation was its small sample size.
The investigators add that the “treatment was well tolerated and seemed to have beneficial effects on GA lesion growth in patients with GA secondary to AMD, particularly in patients with GA lesions 6 mm2 or larger at baseline.”
Kuppermann BD, Patel SS, Boyer DS, et al. Phase 2 study of the safety and efficacy of Brimonidine drug delivery system (Brimo DDS) generation 1 in patients with geographic atrophy secondary to age-related macular degeneration. Retina. 2021;41(1):144-155. doi:10.1097/IAE.0000000000002789