Safety of Lupin's Ranibizumab (Ranieyes) established in Large-Scale Multicenter Study with 2194 injections in 1401 eyes

Real-World Indian Data Confirms Safety of Lupin's Ranieyes for various Chorioretinal Vascular Disease

Ranibizumab (Ranieyes) is a safe intravitreal antivascular endothelial growth factor (Anti -VEGF) agent across various chorioretinal vascular diseases, a recent Large Scale multicenter Indian study has concluded. This study has been published in the November issue of the Ophthalmology and Therapy Journal.

Ranibizumab is a commonly used anti-VEGF therapy to treat chorioretinal vascular diseases. The approved indications for ranibizumab include neovascular age-related macular degeneration (n-AMD), diabetic macular edema (DME), branch retinal vein occlusion (BRVO), and central retinal vein occlusion (CRVO).

Ranieyes is a biosimilar developed by Lupin Pharmaceuticals in India.

To study the safety profile of Ranieyes in multiple eye conditions, a retrospective, consecutive, interventional, uncontrolled multicenter study was conducted using data from three hospital networks in India. The study included 636 males and 533 females with different diagnoses and a mean age of 58.63. It covered 1401 eyes and 2194 Ranieyes injections administered between June 2022 and November 2023, with a minimum follow-up period of six months to assess ocular and systemic adverse events.

The results revealed the safety profile of the biosimilar Ranibizumab (Ranieyes) to be consistent with that of the reference product. Adverse events noted in the study with Lupin’s Ranibizumab are not different than those already described with other anti-VEGF agents or Innovator.

The analysis revealed the following ocular and non-ocular events:

• Non-serious events were observed in 26.83% of injections, with mild ocular pain and transient blurred vision being the most common.
• Serious ocular events occurred in only 0.85% of eyes, with retinal pigment epithelial tear (RPE tear) being the most frequent.
• Systemic adverse events were recorded in 5.03% of patients, with no fatal incidents reported.
• No cases of endophthalmitis were reported.
• There was an average IOP increase from baseline to end was 17.33+/- 1.99 to 18.23mmhg +/- 1.73mmhg

This study showed that biosimilar Ranibizumab (Ranieyes) is a safe and effective anti-VEGF treatment for chorioretinal vascular diseases, providing valuable real-world evidence across a diverse patient population.