July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Phase 3 evaluation of the efficacy and safety of abicipar compared with ranibizumab for treatment of neovascular age-related macular degeneration (nAMD)
Author Affiliations & Notes
  • Derek Kunimoto
    Retinal Consultants of Arizona, Phoenix, Arizona, United States
  • Footnotes
    Commercial Relationships   Derek Kunimoto, Allergan (C), Genentech (C), Graybug Vision (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5193. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Derek Kunimoto; Phase 3 evaluation of the efficacy and safety of abicipar compared with ranibizumab for treatment of neovascular age-related macular degeneration (nAMD). Invest. Ophthalmol. Vis. Sci. 2019;60(9):5193.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Abicipar pegol (abicipar), a DARPin therapeutic, is a selective, high-affinity, vascular endothelial factor (VEGF) inhibitor. Abicipar is smaller than ranibizumab (ran) and has a higher binding affinity for VEGF and a longer half-life in the vitreous, and thus could have a longer duration of action and be effective with fewer intravitreal injections. The efficacy and safety of 2 dosing regimens of abicipar and monthly ran were compared in treatment-naïve patients with nAMD.

Methods : Two randomized, double-masked, phase 3 clinical trials (SEQUOIA, n=949; CEDAR, n=939) with identical protocols in patients with active choroidal neovascularization secondary to AMD and best-corrected-visual acuity (BCVA) of 24–73 ETDRS letters in the study eye. Patients were administered ran 0.5 mg every 4 weeks (q4), abicipar 2 mg every 8 weeks after 3 loading doses at baseline and weeks 4 and 8 (2q8), or abicipar 2 mg every 12 weeks after loading doses at baseline and weeks 4 and 12 (2q12). The primary efficacy measure was proportion of patients with stable vision (<15-letter loss in BCVA from baseline) at Week 52. Safety measures included adverse events (AEs).

Results : Proportion of patients with stable vision at Week 52 was 94.8%, 91.3%, 96.0% (SEQUOIA) and 91.7%, 91.2%, 95.5% (CEDAR) in the abicipar 2q8, abicipar 2q12, ran q4 arms, respectively. Mean gain in BCVA from baseline at Week 52 was 8.3, 7.3, 8.3 letters (SEQUOIA) and 6.7, 5.6, 8.5 letters (CEDAR) in the abicipar 2q8, abicipar 2q12, ran q4 arms, respectively. Mean change in central retinal thickness (CRT) from baseline at Week 52 was −147, −142, −147 µm (SEQUOIA) and −142, −150, −141 µm (CEDAR) in the abicipar 2q8, abicipar 2q12, ran q4 arms, respectively. Overall incidence of AEs was similar among treatment arms in each study. The incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, 0.3% in the abicipar 2q8, abicipar 2q12, ran q4 arms, respectively. IOI AEs typically were mild or moderate in severity and were treated with topical corticosteroids.

Conclusions : Each abicipar regimen (2q8 and 2q12) met the primary endpoint of noninferiority to ran q4 in stable vision at Week 52 in both SEQUOIA and CEDAR. Reductions in CRT at Week 52 were similar between abicipar (after 6–8 injections) and ran (after 13 injections) in both studies. Intraocular inflammation was more frequent with abicipar.

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

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×