• Users Online: 310
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
ORIGINAL ARTICLE
Year : 2016  |  Volume : 28  |  Issue : 3  |  Page : 180-185

Safety and efficacy of Razumab – The new biosimilar in India: Our experience


Department of Vitreo - Retina, M. M. Joshi Eye Institute, Hubli, Karnataka, India

Correspondence Address:
Dr. V V Sameera
M. M. Joshi Eye Institute, Hubli - 580 021, Karnataka
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/kjo.kjo_18_17

Rights and Permissions

Aim: The aim of this study was to evaluate the safety and efficacy of biosimilar intravitreal ranibizumab (Razumab) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and macular edema secondary to retinal vein occlusions (RVOs). Methods: A prospective analysis was performed on consented patients with DME (Group 1), nAMD (Group 2), and macular edema secondary to RVO (Group 3). All patients received Razumab at baseline. Snellen visual acuity assessment, anterior segment and fundus evaluation, fundus photo, and optical coherence tomography imaging were done at days 0, 1, 7, and 30, respectively. The International Society for Clinical Electrophysiology of Vision standard electroretinography (ERG) was performed at baseline and day 30 (23 eyes who could afford the investigation). Primary and secondary outcome measures were safety parameters that included signs of clinical and ERG toxicity and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), respectively. Results: One hundred and twenty-three eyes of 95 patients received biosimilar intravitreal ranibizumab injection between November 2015 and April 2016. No serious drug-related ocular or systemic adverse events were identified. Mean pretreatment BCVA was 0.67 ± 0.41 logMAR with CMT 345.90 ± 128.84 μm and postinjection BCVA at day 30 was 0.57 ± 0.37 logMAR with CMT reducing to 287.66 ± 90.28 μm, indicating statistical significance (P = 0.001 and P< 0.0001, respectively) for all groups. Conclusion: The biosimilar intravitreal ranibizumab for DME, nAMD, and macular edema secondary to RVO was tolerated over a month with improvements in BCVA and CMT without detectable ocular and systemic toxicity. While the long-term safety and efficacy remain unknown, these short-term results suggest that biosimilar ranibizumab could become a safe, low-cost therapy for macular diseases.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed4901    
    Printed54    
    Emailed0    
    PDF Downloaded304    
    Comments [Add]    
    Cited by others 1    

Recommend this journal