July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Phase 2b Study of Brimonidine DDS: Potential Novel Treatment for Geographic Atrophy
Author Affiliations & Notes
  • William R Freeman
    Ophthalmology, UCSD Jacobs Retina Ctr, UCSD Shiley Eye Institute, La Jolla, California, United States
  • Francesco Bandello
    University Vita Salute, Hospital San Raffaele, Milan, Italy
  • Eric H Souied
    Centre Hospitalier Intercommunal de Creteil, Universite Paris Est Creteil, Paris, France
  • Robyn H Guymer
    Center for Eye Research Australia, University of Melbourne, Victoria, Australia
  • Sunir Garg
    Mid Atlantic Retina, Wills Eye Retina Surgeons, Philadelphia, Pennsylvania, United States
  • Fred Kuanfu Chen
    Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Nedlands, Western Australia, Australia
  • Ryan M Rich
    Retina Consultants of Southern Colorado, Colorado Springs, Colorado, United States
  • Frank G Holz
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  • Yan Li
    Allergan plc, Irvine, California, United States
  • Kevin Kerr
    Allergan plc, Irvine, California, United States
  • Francisco J. Lopez
    Allergan plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   William Freeman, Allergan plc (C); Francesco Bandello, Allergan plc (C), Bayer (C), Boehringer-Ingelheim (C), Hofmann La Roche (C), Novartis (C), NTC Pharma (C), SIFI (C), SOOFT (C), Thrombogenics (C), Zeiss (C); Eric Souied, Allergan plc (C), Apellis (C), Bayer (C), Hofmann La Roche (C); Robyn Guymer, None; Sunir Garg, Aerpio (F), Allergan (F), Bausch and Lomb (C), Deciphera (C), Eyegate (F), Wills Eye/Retina Implant AG (C); Fred Chen, None; Ryan Rich, None; Frank Holz, Acucela (C), Acucela (F), Allergan (F), Allergan (R), Apellis (C), Apellis (R), Bayer (C), Bayer (F), Bioeq/Formycon (F), Boehringer-Ingelheim (C), CenterVue (F), Ellex (R), Geuder (C), Grayburg Vision (C), Heidelberg Engineering (C), Lin Bioscience (C), NightStarX (F), Novartis (C), Optos (F), Oxurion (C), Pixium Vision (C), Roche/Genentech (C), Stealth BioTherapeutics (C), Zeiss (F), Zeiss (R); Yan Li, Allergan plc (E); Kevin Kerr, Allergan plc (E); Francisco Lopez, Allergan plc (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 971. doi:https://doi.org/
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    • Get Citation

      William R Freeman, Francesco Bandello, Eric H Souied, Robyn H Guymer, Sunir Garg, Fred Kuanfu Chen, Ryan M Rich, Frank G Holz, Yan Li, Kevin Kerr, Francisco J. Lopez; Phase 2b Study of Brimonidine DDS: Potential Novel Treatment for Geographic Atrophy. Invest. Ophthalmol. Vis. Sci. 2019;60(9):971. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Geographic atrophy (GA) secondary to age-related macular degeneration has no treatment. Therapies targeting the alternative complement pathway and visual cycle modulation have failed to meet primary endpoints in recent trials. Brimonidine has both cyto- and neuroprotective mechanisms which offer a novel approach to treatment. In this Phase 2b study (BEACON), a sustained-release intravitreal formulation of brimonidine (Brimo DDS) was compared with sham treatment to assess safety and efficacy in the reduction of GA expansion rate.

Methods : Approximately three-hundred patients with baseline GA areas 1.25-18mm2 were planned to be recruited and randomized 1:1 to Brimo DDS 400µg or Sham, administered at baseline and every 3 months through Month 21. Safety and efficacy assessments, including GA area by fundus autofluorescence (FAF), were conducted through Month 30. FAF data were analyzed by mixed model repeated measures. A sensitivity analysis was conducted with data transformed to effective radius units (square root of GA lesion area divided by π).

Results : Three hundred and ten patients were enrolled and 53.2% (Brimo DDS) and 54.5% (Sham) of patients completed the Month 24 primary endpoint. Brimo DDS significantly decreased GA growth by 10% (-0.36mm2, p=0.047) at Month 24 and by 12% at Month 30 (-0.52mm2, p=0.017). The effect size increased by 71% in the population with lesion sizes > 4.5 mm2. These results were robust in a sensitivity analysis using effective radius units as the endpoint. Consistent trends in the entire population with reductions of 9% (-0.034mm, p=0.070) were observed at Month 24 and 9% (-0.042mm, p=0.066) at Months 30. Brimo DDS was well-tolerated and there were no unexpected adverse events. Treatment-related events were consistent with those seen with intravitreal injections or visual disturbance from presence of the implant.

Conclusions : Brimo DDS significantly reduced GA progression at Months 24 and 30. Results were robust to a sensitivity analysis in effective radius units. The study intervention was well-tolerated with no unexpected adverse events.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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