June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Abicipar pegol in neovascular age-related macular degeneration (nAMD): comparability between Japanese and non-Japanese patients, and treatment effects on polypoidal choroidal vasculopathy (PCV) and non-PCV patients
Author Affiliations & Notes
  • Derek Kunimoto
    Retinal Consultants of Arizona, Mesa, Arizona, United States
  • Masahito Ohji
    Shiga University of Medical Science, Shiga, Japan
  • Raj K Maturi
    Midwest Eye Institute, Indianapolis, Indiana, United States
  • Tetsuju Sekiryu
    Fukushima Medical University Hospital, Fukushima, Japan
  • Ying Wang
    Allergan plc, Irvine, California, United States
  • Grace Pan
    Allergan plc, Irvine, California, United States
  • Xiao-Yan Li
    Allergan plc, Irvine, California, United States
  • Susan Schneider
    Allergan plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   Derek Kunimoto, Allergan (C), Genentech (C), Graybug (C); Masahito Ohji, Alcon (C), Alcon (F), Allergan (C), B&L (C), Bayer (C), Bayer (F), Hoya (F), Novartis (C), Novartis (F), Otsuka (F), Pfizer (C), Pfizer (F), Santen (C), Santen (F), Senju (F); Raj Maturi, Allegro (F), Allergan (C), Allergan (F), Genentech (F), Graybug (C), Santen (C), Santen (F); Tetsuju Sekiryu, None; Ying Wang, Allergan (E); Grace Pan, Allergan (E); Xiao-Yan Li, Allergan (E); Susan Schneider, Allergan (E)
  • Footnotes
    Support  Allergan plc
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1959. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Derek Kunimoto, Masahito Ohji, Raj K Maturi, Tetsuju Sekiryu, Ying Wang, Grace Pan, Xiao-Yan Li, Susan Schneider; Abicipar pegol in neovascular age-related macular degeneration (nAMD): comparability between Japanese and non-Japanese patients, and treatment effects on polypoidal choroidal vasculopathy (PCV) and non-PCV patients. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1959.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Abicipar pegol belongs to a class of small binding proteins, designed ankyrin repeat protein (DARPin®) therapeutics, with anti-VEGF activity. The present studies (BAMBOO, Japan; CYPRESS, US) further evaluated abicipar safety and efficacy at the lower doses previously evaluated in the Phase 2 REACH study in treatment-naïve patients with nAMD.

Methods : Phase 2, multicenter, double-masked, 20-week studies in patients (n=25 each) with study eye BCVA 24–75 Early Treatment Diabetic Retinopathy Study letters and CRT >320 µm (Spectralis) or >300 µm (Cirrus). Screening indocyanine green angiography was obtained in BAMBOO. Patients were randomized to intravitreal injections of abicipar 1 or 2 mg (n=10 per dose, each study) at baseline and weeks 4 and 8, or ranibizumab 0.5 mg (n=5, each study) at baseline and monthly (for 5 injections). Primary endpoint: mean BCVA change from baseline at week 16. Key secondary endpoint: mean CRT change from baseline. Subgroup analyses were performed.

Results : Mean BCVA change from baseline at week 16 was +7.8, +8.9 and +17.4 (BAMBOO) and +4.4, +10.1 and +15.2 (CYPRESS) letters with abicipar 1 and 2 mg, and ranibizumab, respectively. Mean CRT reduction from baseline at week 16 was 187.3, 196.5, and 230.4 μm (BAMBOO) and 106.5, 112.8, and 124.4 μm (CYPRESS) with abicipar 1 and 2 mg, and ranibizumab, respectively. PCV was detected in 14 Japanese patients (abicipar 1 mg, n=5 and 2 mg, n=6; ranibizumab, n=3) (BAMBOO); mean BCVA change and CRT reduction from baseline at week 16 was +6.0, +9.8 and +12.3 letters and 268.6, 191.2, and 253.7 μm, respectively. In Japanese patients without PCV, BCVA change and CRT reduction was +9.6, +7.5 and +25.0 letters and 106.0, 204.5, and 195.5 μm, respectively. The most common adverse event was conjunctival hemorrhage.

Conclusions : Functional improvement, anatomical effect, and safety were comparable between abicipar arms and consistent across studies. Ranibizumab performed better than registration trials, possibly due to factors such as the small sample, worse baseline VA, and/or lesion characteristics. BCVA change and CRT reduction appear similar between PCV and non-PCV Japanese patients receiving abicipar 2 mg. This dose has performed consistently across Phase 2 studies, supporting its use in Phase 3 trials.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

×
×

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.

×