04Jan 2018

RETROSPECTIVE EFFICACY AND SAFETY ANALYSIS OF ZYBEV (BIOSIMILAR OF BEVACIZUMAB) USE AT TERTIARY EYE CARE CENTRES IN INDIA: SPECTRA STUDY.

  • Medical Services, Cadila Healthcare Ltd, Ahmedabad.
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Purpose: The purpose of this study was to evaluate the efficacy and safety profile of intravitreal injection of bevacizumab biosimilar (Zybev) for various retinal neovascular conditions. Methods: Retrospective analysis was carried out on 108 injections which were administered with intravitreal Zybev injection at different tertiary eye care centers in India. The injections were administered for various indications such as age?related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Results: The mean age of the patients was 62.7 ? 8.40 years. A total of 61.1% injections were administered to men and 39.9% to women. The indications for which the injection was administered were DME (43.6%), AMD (28.7 %), and RVO (27.7%). Mean pretreatment BCVA was 0.94 ? 0.29 logMAR with CMT 355.76 ? 54.9 ?m and postinjection BCVA at day 30 was 0.81 ? 0.26 logMAR with CMT reducing to 292.20 ? 40.81 ?m, indicating statistical significance (P = 0.001 and P < 0.0001, respectively) for all groups. Among the ocular side effects, none of the patients were reported with severe inflammation, endophthalmitis or rise in intraocular pressure (IOP) >21 mm of Hg during follow up period of one month post injection. No systemic adverse events were noted in study population. Conclusion: This retrospective analysis provides real time evidence regarding the efficacy and safety profile of biosimilar of bevacizumab, Zybev. However, more long term, prospective safety and efficacy studies are still awaited, this short term restropective data suggest that Zybev can be effective and safe in the management of ocular conditions including DME, wet AMD and RVO.


  1. Berg K, Pedersen TR, Sandvik L, Bragad?ttir R. Comparison of ranibizumab and bevacizumab for neovascular age related macular degeneration according to LUCAS treat‑and‑extend protocol. Ophthalmology 2015; 122:146‑
  2. CATT Research Group, Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, et al. Ranibizumab and bevacizumab for neovascular age‑related macular degeneration. N Engl J Med 2011;364: 1897‑
  3. Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, et al. Alternative treatments to inhibit VEGF in age‑related choroidalneovascularisation: 2‑year findings of the IVAN randomised controlled trial. Lancet 2013;382: 1258‑
  4. Ehlers JP. The MANTA 1‑year results: The anti‑VEGF debate continues. Br J Ophthalmol 2013;97:248‑
  5. Heier JS, Antoszyk AN, Pavan PR, Leff SR, Rosenfeld PJ, Ciulla TA, et al. Ranibizumab for treatment of neovascular age‑related macular degeneration: A phase I/II multicenter, controlled, multidose study. Ophthalmology 2006;113:633.e1‑
  6. Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, et al. Intravitrealaflibercept (VEGF trap‑eye) in wet age‑related macular degeneration. Ophthalmology 2012;119:2537‑48
  7. Kaiser PK, Cruess AF, Bogaert P, Khunti K, Kelly SP. Balancing risk in ophthalmic prescribing: Assessing the safety of anti‑VEGF therapies and the risks associated with unlicensed medicines, Graefes Arch ClinExpOphthalmol 2012;250:1563‑71
  8. Kodjikian L, Souied EH, Mimoun G, Mauget‑Fa?sse M, Behar‑Cohen F, Decullier E, et al. Ranibizumab versus bevacizumab for neovascular age‑related macular degeneration: Results from the GEFAL noninferiority randomized trial. Ophthalmology 2013;120:2300‑
  9. N Rayess, EhsanRahimy, Philip Storey, Chirag P. Shah, et al, Post-injection endophthalmitis rates and characteristics following intravitrealbevacizumab, ranibizumab and aflibercept Am J Ophthalmol. 2016 May;165:88-93.
  10. PharmacoEconomics& Outcomes News 756, p10 - 2 Jul 2016
  11. Parikh R, Ross JS, et al, Trends of Anti-Vascular Endothelial Growth Factor Use in Ophthalmology Among Privately Insured and Medicare Advantage Patients, Ophtalmology, 2017, Mar;124(3):352-358.
  12. Rosenfield PJ, et al, Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration, Ophthalmic Surg Lasers Imaging, 2005 Jul-Aug;36(4):331-5
  13. in/wp-content/uploads/2017/07/VRSI-Market-Research.pdf

[Sandesh Warudkar. (2018); RETROSPECTIVE EFFICACY AND SAFETY ANALYSIS OF ZYBEV (BIOSIMILAR OF BEVACIZUMAB) USE AT TERTIARY EYE CARE CENTRES IN INDIA: SPECTRA STUDY. Int. J. of Adv. Res. 6 (Jan). 406-410] (ISSN 2320-5407). www.journalijar.com


Dr Sandesh Warudkar
Senior Manager, Medical Services, Cadila Healthcare Ltd, Ahmedabad

DOI:


Article DOI: 10.21474/IJAR01/6234      
DOI URL: http://dx.doi.org/10.21474/IJAR01/6234