Pooled Multicenter Safety Analysis of Lupin's Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal...

Area of Science:

• Ophthalmology
• Retinal Diseases
• Pharmacology

Background:

• Chorioretinal vascular diseases pose significant vision threats.
• Intravitreal anti-VEGF agents are crucial for managing these conditions.
• Evaluating biosimilar safety in real-world settings is essential.

Purpose of the Study:

• To assess the ocular and systemic safety of intravitreal biosimilar ranibizumab (Ranieyes).
• To evaluate Ranieyes in real-world clinical settings for conditions like nAMD, DME, and RVO.
• To compare the safety profile with established anti-VEGF treatments.

Main Methods:

• A retrospective, multicenter study involving 1401 eyes and 2194 Ranieyes injections.
• Data collected from June 2022 to November 2023 across three Indian hospital networks.
• Minimum 6-month follow-up for ocular and systemic adverse events.

Main Results:

• Non-serious ocular adverse events (e.g., mild pain, blurred vision) occurred in 26.83% of injections.
• Serious ocular adverse events were rare (0.85%), with RPE tear being most frequent.
• Systemic adverse events occurred in 5.03% of patients, mostly non-serious; no endophthalmitis observed.

Conclusions:

• Ranieyes exhibits a safe ocular and systemic safety profile in real-world clinical practice.
• The safety profile is consistent with the reference ranibizumab product.
• Ranieyes is a viable treatment option, particularly in resource-constrained settings.