Reported Rates of Intraocular Inflammation with Intravitreal Aflibercept Administered via Pre-Filled Syringe or from Vials in Clinical Practice Between 2012 and 2022

Abstract

Purpose

To determine the reported rates of intraocular inflammation (IOI) in patients treated with intravitreal aflibercept (IVT-AFL) 2 mg in routine clinical practice (ie, outside interventional studies), across all indications and within all countries (excluding the United States), with access to either the vial presentation or pre-filled syringe (PFS).

Patients and methods

A search was conducted using the Bayer EYLEA^® Global Safety Pharmacovigilance Database for reported cases of IOI and IVT-AFL use between October 2012 and March 31, 2022.

Results

With more than 10 years of post-marketing experience with the IVT-AFL vial presentation (>25 million sold units), and over 2 years of experience with the PFS of IVT-AFL (>6.7 million sold units) the rate of any IOI, including endophthalmitis, outside the United States was 0.3 events per 10,000 units for the PFS and 1.2 events per 10,000 units for the vial presentation. The event rates specifically for endophthalmitis were 0.1 per 10,000 units for the IVT-AFL PFS and 0.6 per 10,000 units for the IVT-AFL vial presentation.

Conclusion

In patients with retinal diseases treated in routine clinical practice with IVT-AFL either from a vial or the PFS, medically important adverse events of IOI, and in particular, endophthalmitis, are infrequently reported events. Numerically, reported rates of IOI and endophthalmitis are low for the vial presentation and even lower for the PFS.

Keywords:

• anti-VEGF
• eye
• injection
• IOI
• drug-related side effects and adverse reactions

Research Ethics

This data review does not originate from a dedicated investigational study to analyze this topic. The article summarizes anonymized, post-marketing, case data from Bayer’s Global Safety Database for EYLEA^®, which is maintained in accordance with EU law requiring marketing authorization holders to operate a pharmacovigilance system. As such, this analysis is outside the scope of the Declaration of Helsinki and ethics committee approval was not applicable. In accordance with Article 9(2)(i) of the General Data Protection Regulation (GDPR), which recognizes that processing of health data without informed consent is necessary to fulfill pharmacovigilance legislation, informed consent was not required.

Acknowledgments

Medical writing and editorial support for the preparation of this manuscript, under the direction of the authors, was provided by Sarah Feeny, BMedSci, ApotheCom (London), and was funded by Bayer Consumer Care AG, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidance (Ann Intern Med. 2015;163:461–464).

Disclosure

All authors are salaried employees of, and hold stock options or own stock in, Bayer companies. The authors report no other conflicts of interest in this work.