Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases
Abstract Introduction This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2024-11-01
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| Series: | Ophthalmology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40123-024-01065-z |
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| author | Debdulal Chakraborty Tushar Kanti Sinha Sourav Sinha Aniruddha Maiti Angshuman Mukherjee Krishnendu Nandi Sudipta Das Saptorshi Majumdar Dinesh Rungta Ranabir Bhattacharya |
| author_facet | Debdulal Chakraborty Tushar Kanti Sinha Sourav Sinha Aniruddha Maiti Angshuman Mukherjee Krishnendu Nandi Sudipta Das Saptorshi Majumdar Dinesh Rungta Ranabir Bhattacharya |
| author_sort | Debdulal Chakraborty |
| collection | DOAJ |
| description | Abstract Introduction This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults. Methods We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed. Results The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed. Conclusions This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings. |
| format | Article |
| id | doaj-art-80fc8d0fb0d34e3c90e888c903f3cb02 |
| institution | Kabale University |
| issn | 2193-8245 2193-6528 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj-art-80fc8d0fb0d34e3c90e888c903f3cb022025-01-12T12:10:47ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282024-11-0114112913910.1007/s40123-024-01065-zPooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular DiseasesDebdulal Chakraborty0Tushar Kanti Sinha1Sourav Sinha2Aniruddha Maiti3Angshuman Mukherjee4Krishnendu Nandi5Sudipta Das6Saptorshi Majumdar7Dinesh Rungta8Ranabir Bhattacharya9Disha Eye HospitalsDisha Eye HospitalsNethralayam Superspeciality Eye CareGlobal Eye HospitalDisha Eye HospitalsNethralayam Superspeciality Eye CareNethralayam Superspeciality Eye CareDisha Eye HospitalsDisha Eye HospitalsDisha Eye HospitalsAbstract Introduction This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults. Methods We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed. Results The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed. Conclusions This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings.https://doi.org/10.1007/s40123-024-01065-zRanibizumabBiosimilarChorioretinal vascular diseaseSafety profileIntravitreal injectionReal-world study |
| spellingShingle | Debdulal Chakraborty Tushar Kanti Sinha Sourav Sinha Aniruddha Maiti Angshuman Mukherjee Krishnendu Nandi Sudipta Das Saptorshi Majumdar Dinesh Rungta Ranabir Bhattacharya Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases Ophthalmology and Therapy Ranibizumab Biosimilar Chorioretinal vascular disease Safety profile Intravitreal injection Real-world study |
| title | Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases |
| title_full | Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases |
| title_fullStr | Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases |
| title_full_unstemmed | Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases |
| title_short | Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases |
| title_sort | pooled multicenter safety analysis of lupin s intravitreal biosimilar ranibizumab ranieyes in chorioretinal vascular diseases |
| topic | Ranibizumab Biosimilar Chorioretinal vascular disease Safety profile Intravitreal injection Real-world study |
| url | https://doi.org/10.1007/s40123-024-01065-z |
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