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.

Abstract

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 µg (n = 49), Brimo DDS 264 µg (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 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 and 264 µg than sham; between-group differences were significant (P ≤ 0.032) at Month 3. 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 and 264 µg 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 mm2. The results support Phase 3 development.

• Authors: Baruch D Kuppermann, Sunil S Patel, David S Boyer, Albert J Augustin, William R Freeman, Kevin J Kerr, Qiang Guo, Susan Schneider, Francisco J López, Brimo DDS Gen 1 Study Group
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 41 Issue 1 Pg. 144-155 (Jan 01 2021) ISSN: 1539-2864 [Electronic] United States
• PMID: 32134802 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Opthalmic Communications Society, Inc.

Chemical References

• Adrenergic alpha-2 Receptor Agonists
• Brimonidine Tartrate

Topics

• Adrenergic alpha-2 Receptor Agonists (administration & dosage)
• Aged
• Aged, 80 and over
• Brimonidine Tartrate (administration & dosage)
• Double-Blind Method
• Drug Delivery Systems
• Female
• Fluorescein Angiography (methods)
• Follow-Up Studies
• Fundus Oculi
• Geographic Atrophy (diagnosis, drug therapy, etiology)
• Humans
• Intravitreal Injections
• Macular Degeneration (complications, diagnosis, drug therapy)
• Male
• Middle Aged
• Treatment Outcome
• Visual Acuity