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Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
Published on: July 23, 2016
Comparing safety and efficacy of Bevacizumab, Ranibizumab and Ranibizumab biosimilar in Retinopathy of prematurity
Puja Maitra1, Sujay Jaju2, Kushal U Agrawal3
1Department of Vitreoretina Services, Aravind, Eye Hospital, Chennai, Tamil Nadu, India.
Purpose:
To compare the safety and efficacy of Bevacizumab, Ranibizumab and Ranibizumab biosimilar in treatment of Retinopathy of prematurity (ROP) METHODS: Retrospective study that included newborns with type 1 ROP who received intravitreal Bevacizumab (Avastin) or Ranibizumab (Accentrix) or Ranibizumab biosimilar (Razumab). Babies were followed up as per protocol and retreatment with laser or repeat anti vascular endothelial growth factor (VEGF) was done in case of reactivation and surgery in case of progression to traction. Outcome measures include need for retreatment, proportion of eyes achieving vascularization up to ora and adverse events RESULTS: 148 eyes of 75 babies, received intravitreal injection of which 139 eyes of 70 babies were included in our analysis. 68 eyes received bevacizumab (IVB), 31 eyes received Accentrix (IVA), 40 eyes received Razumab(IVR). The rate of retreatment was 17.6%, 32.2% and 25% for IVB, IVA and IVR respectively (p = 0.1). IVB group showed a significantly delayed reactivation (p < 0.001), while Ranibizumab and its biosimilar Razumab were comparable (p = 0.17). Vascularization up to ora was observed in 60%, 61% and 50% eyes (p = 0.76) at a median of 27, 28 and 24 weeks post-treatment (p = 0.09) in IVB, IVA and IVR groups respectively. No eyes developed intraocular inflammation or cataract.
Conclusion:
All three drugs were similar in their efficacy and safety profile with bevacizumab showing a later reactivation.
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