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| LETTER TO THE EDITOR |
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| Year : 2022 | Volume
: 60
| Issue : 1 | Page : 133 |
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Comments on: Clinical effectiveness and safety of razumab (A biosimilar of ranibizumab)
Mithun Thulasidas
Cataract and Glaucoma Services, Sankara Eye Hospital, Coimbatore, Tamil Nadu, India
| Date of Submission | 19-Jan-2021 |
| Date of Acceptance | 26-Nov-2021 |
| Date of Web Publication | 22-Mar-2022 |
Correspondence Address:
Dr. Mithun Thulasidas
Cataract and Glaucoma Services, Sankara Eye Hospital, Coimbatore, Tamil Nadu
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/tjosr.tjosr_6_21
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 |
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.
Financials support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | |  |
| 1. | 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.  [Full text] |
| 2. | 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. [Full text] |
| 3. | 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. [ PUBMED] [Full text] |
| 4. | 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. |
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