PMID- 33762008 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210328 IS - 2056-9920 (Print) IS - 2056-9920 (Electronic) IS - 2056-9920 (Linking) VI - 7 IP - 1 DP - 2021 Mar 24 TI - Safety and efficacy of Razumab (world's first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study. PG - 24 LID - 10.1186/s40942-021-00293-w [doi] LID - 24 AB - BACKGROUND: Razumab (world's first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD. METHODS: This prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged >/= 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. The patients received intravitreal biosimilar ranibizumab 0.5 mg every 4 weeks for 24 weeks. Safety endpoints included the incidence of adverse events (AEs), serious AEs (SAEs), and immunoreactivity after 6 months. The efficacy endpoints were the proportion of patients who lose fewer than 15 letters, increase in BCVA, change in central retinal thickness (CRT), and change in Visual Function Questionnaire-25 (VFQ-25) score, from baseline to 24 weeks. RESULTS: Of the 126 enrolled patients, majority (95.24%) of the patients received all 6 doses of biosimilar ranibizumab (total 3 mg). Nineteen AEs were reported (n = 16; 12.7%); majority (78.9%) were mild. There were no serious AEs reported, except one AE of death which was unrelated to the study drug. None of the patients discontinued the study due to an AE. The most common ocular AE was increase in intraocular pressure (4 events) and non-ocular AE was pyrexia (5 events). A total of 7.9% (10/126) patients prior to dosing and 7.1% (9/126) patients post-treatment were positive for anti-ranibizumab antibodies. No AEs suggestive of immunogenicity were noted. At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. In the ITT and PP populations, 31.20% and 32.76% patients, respectively, showed improved visual acuity by >/= 15 letters. Significant improvements in BCVA (mean difference: 8.8, 9.2, p < 0.001 for ITT, PP) and VFQ-25 (8.5, 9.2, p < 0.001 for ITT, PP) were seen; CRT reduced significantly (125 microm, 119.3 microm, p < 0.001 for ITT, PP). CONCLUSION: Razumab (world's first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients. Trial registration CTRI/2016/03/006739. Registered 18 March 2016-Prospectively registered, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13141&EncHid=&userName=2016/03/006739. FAU - Sharma, Shashikant AU - Sharma S AUID- ORCID: 0000-0002-7220-653X AD - Medical Affairs, Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India. shashikant_sharma@intaspharma.com. FAU - Gupta, Vishali AU - Gupta V AD - Advanced Eye Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India. FAU - Maiti, Aniruddha AU - Maiti A AD - Susrut Eye Foundation & Research Centre, Kolkata, West Bengal, India. FAU - Natesh, Sribhargava AU - Natesh S AD - Nethra Eye Hospital, Bangalore, Karnataka, India. FAU - Saxena, Sandeep AU - Saxena S AD - Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India. FAU - Dave, Vivek AU - Dave V AD - L V Prasad Eye Institute, Hyderabad, Telangana, India. FAU - Parmar, Vimal AU - Parmar V AD - PBMA's H. V. Desai Eye Hospital, Pune, Maharashtra, India. FAU - Sampangi, Raju AU - Sampangi R AD - Gurushree Hi-Tech Multi Speciality Hospital, Bangalore, Karnataka, India. FAU - Murthy, Hemanth AU - Murthy H AD - Retina Institute of Karnataka, Bangalore, Karnataka, India. FAU - Dharwadkar, Sandhya AU - Dharwadkar S AD - K.R. Hospital, Mysore Medical College & Research Institute, Mysore, India. FAU - Yadav, Naresh Kumar AU - Yadav NK AD - Narayana Nethralaya, Bangalore, Karnataka, India. FAU - Joshi, Shrinivas AU - Joshi S AD - M M Joshi Eye Institute, Hubli, Karnataka, India. FAU - Mayor, Rahul AU - Mayor R AD - Dr. Shroff's Charity Eye Hospital, New Delhi, India. FAU - Ratra, Dhanashree AU - Ratra D AD - Sankara Nethralaya, Chennai, Tamil Nadu, India. FAU - Basu, Soumyava AU - Basu S AD - L V Prasad Eye Institute, Bhubaneswar, Odisha, India. FAU - Goel, Neha AU - Goel N AD - ICARE Eye Hospital & Post Graduate Institute, Noida, Uttar Pradesh, India. AD - Eye7 Chaudhary Eye Centre, New Delhi, India. FAU - Chaturvedi, Alok AU - Chaturvedi A AD - Medical Affairs, Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India. FAU - Patel, Ronak AU - Patel R AD - Department of Biostatistics and Programming, Lambda Therapeutic Research Ltd., Ahmedabad, Gujarat, India. FAU - Jose, Vinu AU - Jose V AD - Clinical Development & Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma), Ahmedabad, Gujarat, India. LA - eng PT - Journal Article DEP - 20210324 PL - England TA - Int J Retina Vitreous JT - International journal of retina and vitreous JID - 101677897 PMC - PMC7992797 OTO - NOTNLM OT - AMD OT - Biosimilar ranibizumab OT - Neovascular OT - Razumab OT - Safety OT - Wet age-related macular degeneration COIS- Drs. Shashikant Sharma and Alok Chaturvedi are employees of Intas Pharmaceuticals Ltd, Ahmedabad, India and Dr. Vinu Jose is an employee of Intas Pharmaceuticals Ltd. (Biopharma), Ahmedabad, India. Mr. Ronak Patel is an employee of Lambda Therapeutic Research Limited, Ahmedabad, India. EDAT- 2021/03/26 06:00 MHDA- 2021/03/26 06:01 PMCR- 2021/03/24 CRDT- 2021/03/25 05:41 PHST- 2020/09/24 00:00 [received] PHST- 2021/03/09 00:00 [accepted] PHST- 2021/03/25 05:41 [entrez] PHST- 2021/03/26 06:00 [pubmed] PHST- 2021/03/26 06:01 [medline] PHST- 2021/03/24 00:00 [pmc-release] AID - 10.1186/s40942-021-00293-w [pii] AID - 293 [pii] AID - 10.1186/s40942-021-00293-w [doi] PST - epublish SO - Int J Retina Vitreous. 2021 Mar 24;7(1):24. doi: 10.1186/s40942-021-00293-w.