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Year : 2022  |  Volume : 60  |  Issue : 1  |  Page : 133

Comments on: Clinical effectiveness and safety of razumab (A biosimilar of ranibizumab)

Cataract and Glaucoma Services, Sankara Eye Hospital, Coimbatore, Tamil Nadu, India

Date of Submission19-Jan-2021
Date of Acceptance26-Nov-2021
Date of Web Publication22-Mar-2022

Correspondence Address:
Dr. Mithun Thulasidas
Cataract and Glaucoma Services, Sankara Eye Hospital, Coimbatore, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/tjosr.tjosr_6_21

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How to cite this article:
Thulasidas M. Comments on: Clinical effectiveness and safety of razumab (A biosimilar of ranibizumab). TNOA J Ophthalmic Sci Res 2022;60:133

How to cite this URL:
Thulasidas M. Comments on: Clinical effectiveness and safety of razumab (A biosimilar of ranibizumab). TNOA J Ophthalmic Sci Res [serial online] 2022 [cited 2023 Mar 21];60:133. Available from: https://www.tnoajosr.com/text.asp?2022/60/1/133/340367

To the Editor,

I read with interest the study by Gopal et al. in which they evaluated the safety and efficacy of intravitreal biosimilar Razumab© in the treatment of wet age-related macular degeneration (ARMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). The study outcomes showed that Razumab©, the biosimilar of ranibizumab, is an effective treatment alternative in the management of wet ARMD, DME, and RVO by reducing central foveal thickness (CFT) and improving visual acuity at the end of 1 month.[1]

The authors have not given any statements about the ethical committee approval/waiver and the maintenance of the confidentiality of the patients, which are considered essential for an originally conducted study. The details of the statistical analysis of the study regarding the methods used are also not described. An explanation of these aspects would be appreciated.

The study included patients who had active or previously treated retinal vascular conditions. Two hundred and nine eyes were treatment naïve, and one hundred eyes had been previously treated with anti-vascular endothelial growth factor (VEGF) agents or intravitreal steroids in the past 6 months. As including patients who were not treatment naïve may act as a confounding factor and affect the study outcomes, a separate analysis of only treatment naïve patients would have given more meaningful results.[2],[3]

Further, in methodology, defining CFT would have given the readers a better understanding of how CFT is measured depending on different commercially available optical coherence tomography (OCT) instruments. The Spectralis Heidelberg Engineering Retinal Angiography HRA+OCT and Cirrus HD-OCT include the retinal pigment epithelium layer in the retinal segmentation algorithm for CFT measurement, whereas the other instruments do not.[4]

The authors mentioned about the mean reduction in CFT and improvement in visual acuity at the end of 1 month. However, it will be interesting to know in detail rather than the mean values, whether any patient had worsening of CFT and visual acuity post injection.

I believe a response from the authors on my comments will add to the translational value of the study and help the vitreoretinal surgeons to achieve good outcomes using biosimilar anti-VEGF drugs in patients with chorioretinal vascular diseases.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Gopal S, Kasturirangan S, Madhivanan N, Henry H, Nivean PD, Shekharan S. Clinical effectiveness and safety of Razumab (a biosimilar of ranibizumab). TNOA J Ophthalmic Sci Res 2020;58:154-8.  Back to cited text no. 1
  [Full text]  
Sameera VV, Apoorva AG, Joshi S, Guruprasad AS. Safety and efficacy of Razumab – The new biosimilar in India: Our experience. Kerala J Ophthalmol 2016;28:180-5.  Back to cited text no. 2
  [Full text]  
Verma L, Thulasidas M, Purohit A, Gupta A, Narula R, Talwar D. Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar ranibizumab. Indian J Ophthalmol 2021;69:347-51.  Back to cited text no. 3
[PUBMED]  [Full text]  
Wolf-Schnurrbusch UE, Ceklic L, Brinkmann CK, Iliev ME, Frey M, Rothenbuehler SP, et al. Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci 2009;50:3432-7.  Back to cited text no. 4


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