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

Purpose: To evaluate the safety and efficacy of Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant, in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Methods: Phase 2, randomized, multicenter, double-masked, 24-month study. Study eyes were treated (Day 1; Month 6 retreatment) with Brimo DDS 132 mu g (n = 49), Brimo DDS 264 mu g (n = 41), or sham procedure (n = 23). The primary timepoint for efficacy analysis was Month 12. Results: Mean GA area growth at Month 12 was 1.78 mm(2), 1.59 mm(2), and 2.19 mm(2) in the Brimo DDS 132 mu g, 264 mu g, and sham groups, respectively. Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 mu g than sham; between-group differences were significant (P <= 0.032) at Month 3. In patients with baseline lesion area >= 6 mm(2) (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 and 264 mu g at Month 12 (P <= 0.050 vs. sham). Treatment-related adverse events were usually injection procedure-related. Conclusion: Brimo DDS demonstrated a favorable safety profile and reduced GA lesion area growth at Month 3. Lesion growth at Month 12 was reduced in patients with baseline GA lesion area >= 6 mm(2). The results support Phase 3 development.

Automated summary

The Brinidine drug delivery system showed favorable safety and efficacy in treating geographic atrophy secondary to age-related macular degeneration, with reduced lesion growth.