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Drug Profile

Abicipar pegol for neovascular age-related macular degeneration

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Pages 999-1008 | Received 14 Feb 2020, Accepted 10 Jun 2020, Published online: 03 Jul 2020

References

  • Friedman DS, O’Colmain BJ, Munoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthal. 2004 Apr;122(4):564–572.
  • Owen CG, Jarrar Z, Wormald R, et al. The estimated prevalence and incidence of late stage age related macular degeneration in the UK. Br J Ophthalmol. 2012 May;96(5):752–756.
  • Ferris FL III, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthal. 1984;102(11):1640–1642.
  • Donald J, Gass M. Pathogenesis of disciform detachment of the neuroepithelium: I. general concepts and classification. Am J Ophthalmol. 1967 1967/03/01/;63(3, Part 2):573/1–585/13.
  • Green WR, Enger C. Age-related macular degeneration histopathologic studies: the 1992 Lorenz E. Retinal physician lecture. Ophthalmol. 1993;100(10):1519–1535.
  • Leung D, Cachianes G, Kuang W, et al. Vascular endothelial growth factor is a secreted angiogenic mitogen. Science. 1989;246(4935):1306–1309.
  • Senger DR, Galli SJ, Dvorak AM, et al. Tumor cells secrete a vascular permeability factor that promotes accumulation of ascites fluid. Science. 1983 Feb 25;219(4587):983–985.
  • Miller JW, Le Couter J, Strauss EC, et al. Vascular endothelial growth factor a in intraocular vascular disease. Ophthalmology. 2013 Jan;120(1):106–114.
  • Holmes DIR, Zachary I. The vascular endothelial growth factor (VEGF) family: angiogenic factors in health and disease. Genome Biol. 2005;6(2):209.
  • Gerber HP, McMurtrey A, Kowalski J, et al. Vascular endothelial growth factor regulates endothelial cell survival through the phosphatidylinositol 3ʹ-kinase/Akt signal transduction pathway. Requirement for Flk-1/KDR activation. J Biol Chem. 1998 Nov 13;273(46):30336–30343.
  • Kim I, Moon SO, Kim SH, et al. Vascular endothelial growth factor expression of intercellular adhesion molecule 1 (ICAM-1), vascular cell adhesion molecule 1 (VCAM-1), and E-selectin through nuclear factor-kappa B activation in endothelial cells. J Biol Chem. 2001 Mar 09;276(10):7614–7620.
  • Smith AG, Kaiser PK. Emerging treatments for wet age-related macular degeneration. Expert Opin Emerg Drugs. 2014 Mar;19(1):157–164.
  • Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 05;355(14):1432–1444.
  • Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 05;355(14):1419–1431.
  • Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537–2548.
  • Group CR, Martin DF, Maguire MG, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20): 1897–1908.
  • Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020 Jan;127(1):72–84.
  • Rodrigues GA, Mason M, Christie LA, et al. Functional characterization of abicipar-pegol, an anti-VEGF DARPin therapeutic that potently inhibits angiogenesis and vascular permeability. Invest Ophthalmol Vis Sci. 2018 Dec 3;59(15):5836–5846.
  • Al-Khersan H, Hussain RM, Ciulla TA, et al. Innovative therapies for neovascular age-related macular degeneration. Expert Opin Pharmacother. 2019;12:1–13.
  • Barthelmes D, Nguyen V, Daien V, et al. Two year outcomes of “treat and extend” intravitreal therapy using aflibercept preferentially for neovascular age-related macular degeneration. Retina. 2018;38(1):20–28.
  • Arevalo JF, Lasave AF, Wu L, et al. Intravitreal bevacizumab for choroidal neovascularization in age-related macular degeneration: 5-year results of the pan-American collaborative retina study group. Retina. 2016;36(5):859–867.
  • Cohen SY, Mimoun G, Oubraham H, et al. Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the LUMIERE study. Retina. 2013 Mar;33(3):474–481.
  • Hjelmqvist L, Lindberg C, Kanulf P, et al. One-year outcomes using ranibizumab for neovascular age-related macular degeneration: results of a prospective and retrospective observational multicentre study. J Ophthalmol. 2011;2011:405724.
  • Holz FG, Tadayoni R, Beatty S, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220–226.
  • Kruger Falk M, Kemp H, Sorensen TL. Four-year treatment results of neovascular age-related macular degeneration with ranibizumab and causes for discontinuation of treatment. Am J Ophthalmol. 2013 Jan;155(1):89–95 e3.
  • Rakic JM, Leys A, Brie H, et al. Real-world variability in ranibizumab treatment and associated clinical, quality of life, and safety outcomes over 24 months in patients with neovascular age-related macular degeneration: the HELIOS study. Clin Ophthalmol. 2013;7:1849–1858.
  • Rasmussen A, Bloch SB, Fuchs J, et al. A 4-year longitudinal study of 555 patients treated with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2013 Dec;120(12):2630–2636.
  • Souied EH, Oubraham H, Mimoun G, et al. Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the TWIN Study. Retina. 2015 Sep;35(9):1743–1749.
  • Talks JS, Lotery AJ, Ghanchi F, et al. First-year visual acuity outcomes in the United Kingdom of providing aflibercept according to the VIEW study protocol for age-related macular degeneration. Ophthalmology. 2016;123(2):337–343.
  • van Asten F, Evers-Birkenkamp KU, van Lith-verhoeven JJ, et al. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration. Acta Ophthalmol. 2015 Mar;93(2):126–133.
  • Writing Committee for the U. K. Age-related macular degeneration E. M. R. Users group. The neovascular age-related macular degeneration database: multicenter study of 92 976 ranibizumab injections: report 1: visual acuity. Ophthalmology. 2014 May;121(5):1092–1101.
  • Zarranz-Ventura J, Liew G, Johnston RL, et al. The neovascular age-related macular degeneration database: report 2: incidence, management, and visual outcomes of second treated eyes. Ophthalmology. 2014 Oct;121(10):1966–1975.
  • Ross AH, Donachie PH, Sallam A, et al. Which visual acuity measurements define high-quality care for patients with neovascular age-related macular degeneration treated with ranibizumab? Eye (Lond). 2013 Jan;27(1):56–64.
  • Rao P, Lum F, Wood K, et al. Real-world vision in age-related macular degeneration patients treated with single anti-VEGF drug type for 1 year in the IRIS registry. Ophthalmology. 2018;125:522–528.
  • Ciulla TA, Hussain RM, Pollack JS, et al. Visual acuity outcomes and anti-vascular endothelial growth factor therapy intensity in neovascular AMD patients: a “real world” analysis in 49,485 eyes. Ophthalmol Retina. 2020;4(1):19–30.
  • Dadgostar H, Ventura AA, Chung JY, et al. Evaluation of injection frequency and visual acuity outcomes for ranibizumab monotherapy in exudative age-related macular degeneration. Ophthalmology. 2009 Sep;116(9):1740–1747.
  • Hussain RM, Hariprasad SM, Ciulla TA. Treatment burden in neovascular AMD: visual acuity outcomes are associated with anti-VEGF injection frequency. Ophthalmic Surg Lasers Imaging Retina. 2017 Oct 1;48(10):780–784.
  • Daniel E, Toth CA, Grunwald JE, et al. Risk of scar in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Mar;121(3):656–666.
  • Jaffe GJ, Ciulla TA, Ciardella AP, et al. Dual antagonism of PDGF and VEGF in neovascular age-related macular degeneration: a phase IIb, multicenter, randomized controlled trial. Ophthalmology. 2017 Feb;124(2):224–234.
  • Dunn EN, Hariprasad SM, Sheth VS. An overview of the Fovista and Rinucumab trials and the fate of anti-PDGF medications. Ophthalmic Surg Lasers Imaging Retina. 2017 Feb 1;48(2):100–104.
  • Hussain RM, Neiweem AE, Kansara V, et al. Tie-2/Angiopoietin pathway modulation as a therapeutic strategy for retinal disease. Expert Opin Investig Drugs. 2019 Oct;28(10):861–869.
  • Moore NA, Bracha P, Hussain RM, et al. Gene therapy for age-related macular degeneration. Expert Opin Biol Ther. 2017 Oct;17(10):1235–1244.
  • Moisseiev E, Loewenstein A Abicipar pegol-a novel anti-VEGF therapy with a long duration of action. Eye (Lond). 2019 Sep 19.
  • Pluckthun A. Designed ankyrin repeat proteins (DARPins): binding proteins for research, diagnostics, and therapy. Annu Rev Pharmacol Toxicol. 2015;55:489–511.
  • Eggel A, Buschor P, Baumann MJ, et al. Inhibition of ongoing allergic reactions using a novel anti-IgE DARPin-Fc fusion protein. Allergy. 2011 Jul;66(7):961–968.
  • Stumpp MT, Binz HK, Amstutz P. DARPins: a new generation of protein therapeutics. Drug Discov Today. 2008 Aug;13(15–16):695–701.
  • Wetzel SK, Settanni G, Kenig M, et al. Folding and unfolding mechanism of highly stable full-consensus ankyrin repeat proteins. J Mol Biol. 2008 Feb 8;376(1):241–257.
  • Souied EH, Devin F, Mauget-Faysse M, et al. Treatment of exudative age-related macular degeneration with a designed ankyrin repeat protein that binds vascular endothelial growth factor: a phase I/II study. Am J Ophthalmol. 2014 Oct;158(4):724–732 e2.
  • Campochiaro PA, Channa R, Berger BB, et al. Treatment of diabetic macular edema with a designed ankyrin repeat protein that binds vascular endothelial growth factor: a phase I/II study. Am J Ophthalmol. 2013 Apr;155(4):697–704, 704 e1–2.
  • Krohne TU, Liu Z, Holz FG, et al. Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans. Am J Ophthalmol. 2012 Oct;154(4):682–686 e2.
  • Stahl A, Stumpp MT, Schlegel A, et al. Highly potent VEGF-A-antagonistic DARPins as anti-angiogenic agents for topical and intravitreal applications. Angiogenesis. 2013 Jan;16(1):101–111.
  • Callanan D, Kunimoto D, Maturi RK, et al. Double-masked, randomized, phase 2 evaluation of abicipar pegol (an Anti-VEGF DARPin therapeutic) in neovascular age-related macular degeneration. J Ocul Pharmacol Ther. 2018;34(10):700–709.
  • Kunimoto D, Ohji M, Maturi RK, et al. Evaluation of abicipar pegol (an anti-VEGF DARPin therapeutic) in patients with neovascular age-related macular degeneration: studies in Japan and the United States. Ophthalmic Surg Lasers Imaging Retina. 2019 Feb 1;50(2):e10–e22.
  • Matsumiya W, Honda S, Otsuka K, et al. Comparison of the effectiveness and prognostic factors of intravitreal ranibizumab between typical neovascular age-related macular degeneration and polypoidal choroidal vasculopathy over 24 months of follow-up. Ophthalmologica. 2015;234(1):33–39.
  • Allergan and Molecular Partners Announce Two Positive Phase. 3 clinical trials for abicipar pegol 8 and 12-week regimens for the treatment in patients with neovascular age-related macular degeneration [Internet]. Dublin: Allergan; 2018.
  • Khurana RN Abicipar for neovascular age-related macular degeneration: two-year results from CEDAR and SEQUOIA phase 3. Presented at: American Academy of Ophthalmology annual meeting; 2019 October 11–15; San Francisco, CA.
  • Allergan and Molecular Partners Announce Topline Safety Results from MAPLE study of Abicipar pegol. [cited 2019 Oct 6]. Available from: https://www.allergan.com/news/news/thomson-reuters/allergan-and-molecular-partners-announce-topline-s.aspx
  • Cunningham ET Jr. Clinical trial closeup: a deeper dive into abicipar trials 2018. [cited 2020 Jan 21]. Available from: http://www.retina-specialist.com/article/a-deeper-dive-into-abicipar-trials
  • Moja L, Lucenteforte E, Kwag KH, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Sep;15(9):CD011230.
  • Dalvin LA, Starr MR, AbouChehade JE, et al. Association of intravitreal anti-vascular endothelial growth factor therapy with risk of stroke, myocardial infarction, and death in patients with exudative age-related macular degeneration. JAMA Ophthalmol. 2019 May 1;137(5):483–490.
  • Baek SU, Park IW, Suh W. Long-term intraocular pressure changes after intravitreal injection of bevacizumab. Cutan Ocul Toxicol. 2016 Dec;35(4):310–314.
  • Chang LK, Sarraf D. Tears of the retinal pigment epithelium: an old problem in a new era. Retina. 2007 Jun;27(5):523–534.
  • Bracha P, Moore NA, Ciulla TA, et al. The acute and chronic effects of intravitreal anti-vascular endothelial growth factor injections on intraocular pressure: A review. Surv Ophthalmol. 2018 May - Jun;63(3):281–295.
  • Rayess N, Rahimy E, Storey P, et al. Postinjection endophthalmitis rates and characteristics following intravitreal bevacizumab, ranibizumab, and aflibercept. Am J Ophthalmol. 2016 May;165:88–93.
  • Silva R, Berta A, Larsen M, et al. Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: results with ranibizumab from the TREND study. Ophthalmology. 2018 Jan;125(1):57–65.
  • Kertes PJ, Galic IJ, Greve M, et al. Canadian treat-and-extend analysis trial with ranibizumab in patients with neovascular age-related macular disease: one-year results of the randomized Canadian treat-and-extend analysis trial with ranibizumab study. Ophthalmology. 2019 Jun;126(6):841–848.
  • Berg K, Pedersen TR, Sandvik L, et al. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology. 2015 Jan;122(1):146–152.
  • Wykoff CC, Croft DE, Brown DM, et al. Prospective trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration: TREX-AMD 1-year results. Ophthalmology. 2015 Dec;122(12):2514–2522.
  • Greenberg JP, Belin P, Butler J, et al. Aflibercept-related sterile intraocular inflammation outcomes. Ophthalmol Retina. 2019 Sep;3(9):753–759.
  • Reed K, Gibosn A, Musser BJ, et al. Analysis of intraocular inflammation following intravitreal injection of eylea. Retinal Physician. 2018;15(October 2018):26–30.
  • Hariprasad SM, Blinder KJ, Shah GK, et al. Penetration pharmacokinetics of topically administered 0.5% moxifloxacin ophthalmic solution in human aqueous and vitreous. Arch Ophthalmol. 2005 Jan;123(1):39–44.
  • Hariprasad SM, Shah GK, Mieler WF, et al. Vitreous and aqueous penetration of orally administered moxifloxacin in humans. Arch Ophthalmol. 2006 Feb;124(2):178–182.

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