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Ranibizumab

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Abstract

  • ▴ Ranibizumab is the antigen-binding fragment of a recombinant, humanised monoclonal antibody, which binds with high affinity to, and inhibits the activity of, all active forms of vascular endothelial growth factor A, an important mediator in the development of choroidal neovascularisation.

  • ▴ Well designed, phase III trials in patients with neovascular (wet) age-related macular degeneration (AMD) indicated that monthly intravitreal injections of ranibizumab 0.3 or 0.5mg for up to 2 years maintained or improved visual acuity to a greater extent than sham injection, verteporfin photodynamic therapy or sham photodynamic therapy.

  • ▴ In patients with predominantly classic wet AMD who received ranibizumab in combination with verteporfin therapy, preliminary results indicate that combination therapy is superior to that of verteporfin therapy alone.

  • ▴ Most serious ocular adverse events, which were uncommon, were associated with either the injection procedure or ranibizumab.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

References

  1. Eter N, Krohne TU, Holz FG. New pharmacologic approaches to therapy for age-related macular degeneration. Biodrugs 2006; 20 (3): 167–79

    Article  PubMed  CAS  Google Scholar 

  2. Barouch FC, Miller JW. Anti-vascular endothelial growth factor strategies for the treatment of choroidal neovascularization from age-related macular degeneration. Int Ophthalmol Clin 2004; 44 (3): 23–32

    Article  PubMed  Google Scholar 

  3. Comer GM, Ciulla TA, Criswell MH, et al. Current and future treatment options for nonexudative and exudative age-related macular degeneration. Drugs Aging 2004; 21 (15): 967–92

    Article  PubMed  CAS  Google Scholar 

  4. Sorbera LA, Leeson PA, Bayés M. Ranibizumab: treatment of age-related macular degeneration humanized monoclonal anti-VEGF antibody angiogenesis inhibitor. Drugs Future 2003; 28 (6): 541–5

    Article  CAS  Google Scholar 

  5. Gragoudas ES, Adamis AP, Cunningham ET, et al. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 2004 Dec 30; 351 (27): 2805–16

    Article  PubMed  CAS  Google Scholar 

  6. Melnikova I. Wet age-related macular degeneration. Nat Rev Drug Discov 2005 Sep; 4 (9): 711–2

    Article  PubMed  CAS  Google Scholar 

  7. Ng EWM, Adamis AP. Targeting angiogenesis, the underlying disorder in neovascular age-related macular degeneration. Can J Ophthalmol 2005; 40 (3): 352–68

    PubMed  Google Scholar 

  8. Rosenfeld PJ, Rich RM, Lalwani GA. Ranibizumab: phase III clinical trial results. Ophthalmol Clin North Am 2006 Sep; 19 (3): 361–72

    PubMed  Google Scholar 

  9. US Food and Drug Administration. Ranibizumab: full prescribing information [online]. Available from URL: http://www.fda.gov/cder/foi/label/2006/1251561bl.pdf [Accessed 2007 May 10]

  10. Lowe J, Araujo J, Palma M, et al. RhuFab V2 inhibits VEGF-isoforms-stimulated HUVEC proliferation [E-abstract no. 1828]. Invest Ophthalmol Vis Sci 2003; 44

  11. Rosenfeld PJ, Heier JS, Hantsbarger G, et al. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis™) for neovascular age-related macular degeneration. Ophthalmology 2006 Apr; 113 (4): 623–32

    Article  PubMed  Google Scholar 

  12. Heier JS, Antoszyk AN, Pavan PR, et al. Ranibizumab for treatment of neovascular age-related macular degeneration a phase I/II multicenter, controlled, multidose study [abstract]. Ophthalmology 2006; 113 (4): 642

    Article  Google Scholar 

  13. Rosenfeld PJ, Fung AE, Lalwani GA, et al. Visual acuity outcomes following a variable-dosing regimen for ranibizumab (Lucentis™) in neovascular AMD: the PrONTO study [abstract no. 2958]. Annual Meeting of the Association for Research in Vision and Ophthalmology; 2006 Apr 30–May 4; Fort Lauderdale (FL)

  14. Korotkin A, Kozak I, Morrison VL, et al. An emerging problem: recurrence of CNV in AMD is common after cessation of 24 month treatment with ranibizumab (Lucentis®) [abstract no. 2961]. Annual Meeting of the Association for Research in Vision and Ophthalmology; 2006 Apr 30–May 4; Fort Lauderdale (FL)

  15. Heier JS, Rosenfeld PJ, Antoszyk G, et al. Long-term experience with Lucentis™ (ranibizumab) in patients with neovascular age-related macular degeneration (AMD) [E-abstract no. 1393]. Invest Ophthalmol Vis Sci 2005 May; 46

  16. Lalwani G, Fung AE, Michels S, et al. Optical coherence tomography findings in a variable-dosing regimen with ranibizumab (Lucentis™): the PrONTO study [abstract no. 2147]. Annual Meeting of the Association for Research in Vision and Ophthamology; 2006 Apr 30–May 4; Fort Lauderdale (FL)

  17. Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006 Oct 5; 355 (14): 1432–44

    Article  PubMed  CAS  Google Scholar 

  18. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006 Oct 5; 355 (14): 1419–31

    Article  PubMed  CAS  Google Scholar 

  19. Rosenfeld PJ, Schwartz SD, Blumenkranz MS, et al. Maximum tolerated dose of a humanized anti-vascular endothelial growth factor antibody fragment for treating neovascular age-related macular degeneration. Ophthalmology 2005 Jun; 112 (6): 1048–53

    Article  PubMed  Google Scholar 

  20. Haughney PC, Lowe J, Kearns A, et al. Clinical pharmacokinetics of ranibizumab (Lucentis™) in subjects with AMD [E-abstract no. 1383]. Invest Ophthalmol Vis Sci 2005; 46

  21. European Medicines Agency. Ranibizumab (Lucentis): summary of product characteristics [online]. Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/lucentis/H-715-PI-en.pdf [Accessed 2007 Apr 12]

  22. Gaudreault J, Fei D, Rusit J, et al. Preclinical pharmacokinetics of ranibizumab (rhuFabV2) after a single intravitreal administration. Invest Ophthalmol Vis Sci 2005 Feb; 46 (2): 726–33

    Article  PubMed  Google Scholar 

  23. Schmidt-Erfurth U. The PIER study: twelve month efficacy and safety results from a phase III study of ranibizumab 0.3mg and 0.5mg administered initially monthly and then every 3 months for subfoveal choroidal neovascularization secondary to age-related macular degeneration. PIER study group [abstract no. F1116]. Asian J Ophthalmol 2006; 8 (3 Suppl. 1): 176

    Google Scholar 

  24. Brown DM, Yue H, Shams N. Ranibizumab (Lucentis) in neovascular age-related macular degeneration (AMD): subgroup analysis of year 1 PIER efficacy data [abstract no. 4540/B221]. Annual Meeting of the Association for Research in Vision and Ophthalmology; 2007 May 6–10; Fort Lauderdale (FL)

  25. Chang TS, Fine JT, Bressler N, et al. Self-reported vision-specific quality of life at 1 year in patients with neovascular age-related macular degeneration in 2 phase III randomized clinical trials of ranibizumab (Lucentis™) [abstract no. 5252]. Annual Meeting of the Association for Research in Vision and Ophthamology; 2006 Apr 30–May 4; Fort Lauderdale (FL)

  26. Brown DM, Shapiro H, Schneider S, et al. Subgroup analysis of first-year results of ANCHOR: a phase III, double-masked, randomized comparison of ranibizumab and verteporfin photo-dynamic therapy for predominantly classic choroidal neovascularization related to age-related macular degeneration [abstract no. 2963]. Annual Meeting of the Association for Research in Vision and Ophthamology; 2006 Apr 30-May 4; Fort Lauderdale (FL)

  27. Heier JS, Boyer DS, Ciulla TA, et al. Ranibizumab combined with verteporfin photodynamic therapy in neovascular agerelated macular degeneration: year 1 results of the FOCUS study. Arch Ophthalmol 2006; 124 (11): 1532–42 28. Genentech, Inc. Dear health care provider letter regarding Lucentis [online]. Available from URL: http://www.fda.gov/medwatch/safety/2007/Lucentis_DHCP_01-24-2007.pdf [Accessed 2007 Jan 30] 29. US Food and Drug Administration. 2007 Safety alerts for drugs, biologies, medical devices, and dietary supplements [online]. Available from URL: http://www.fda.gov/medwatch/safety/2007/safety07.htm [Accessed 2007 May 4]

    Article  PubMed  CAS  Google Scholar 

  28. Genentech, Inc. Dear health care provider letter regarding Lucentis [online]. Available from URL: http://www.fda.gov/ [Accessed 2007 Jan 30]

  29. US Food and Drug Administration. 2007 Safety alerts for drugs, biologics, medical devices, and dietary supplements [online]. Available from URL: http://www.fda.gov/ [Accessed 2007 May 4]

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Correspondence to Stephanie K. A. Blick.

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Blick, S.K.A., Keating, G.M. & Wagstaff, A.J. Ranibizumab. Drugs 67, 1199–1206 (2007). https://doi.org/10.2165/00003495-200767080-00007

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