Risk of intraocular pressure spike after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation

Author: Jakob Siedlecki (Germany)

Co-authors: Vinh Bui, Niklas Maierhofer, Benedikt Schworm, Mathias Maier, Siegfried Priglinger, Julian Klaas

Purpose

To compare the risk of severe intraocular pressure spike (IOPS) with transient central retinal artery occlusion after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the old vial system.

Setting/Venue

Intravitreal injection service of the Ludwig Maximilians-University Munich and Technical University Munich, Departments of Ophthalmology

Methods

The databases of the Ludwig Maximilians-University Munich and the Technical University Munich, Germany, were screened for patients with IOPS after intravitreal injection of aflibercept. The observation period included two full months prior to the introduction of the novel PFS and two months afterwards. IOPS was defined as loss of perception of hand movement for a duration of more than 30 seconds.

Results

Over a period of four months, 1720 intravitreal injections of aflibercept were administered in in 672 patients. There were 842 injections with the old vial system, and 878 injections using the novel PFS. Using the vial system, IOPS was noted during two injections (0.24 %) in two patients, as compared to 11 cases of IOPS (1.25%) in 10 patients with the PFS (p=0.015). Using the PFS, patients had a 5.3-fold risk of IOPS as compared to the vial system (OR: 5.33; 95 % CI: 1.2 – 24.1; p=0.0298).

Conlusions

There was a more than five-fold risk of severe intraocular pressure spike using the novel pre-filled aflibercept syringe as compared to the established vial system. This study adds evidence to the data recently communicated by the European Medicines Agency (EMA).

Financial Disclosure

No financial interests relevant to this study.