Session Title: Vitreo Retinal Surgery I
Session Date/Time: Thursday 11/09/2014 | 08:00-10:00
Paper Time: 09:04
First Author: : P.Stalmans BELGIUM
Co Author(s): : J. Van Calster
Clinical trials are essential for establishing the efficacy and safety profiles of new medicines. However, they are not always powered to identify rare adverse events (AEs), and the patient populations do not necessarily reflect those encountered in ‘real-world’ medical practice. Post-approval safety evaluations are essential for assessing the AE profile of a drug in the everyday clinical setting to ensure a sufficiently high standard of patient care. Here, we present an overview of the post-approval safety profile of ocriplasmin 125 µg intravitreal injection.
Ocriplasmin 125 µg intravitreal injection is approved in the United States (US) and Canada for the treatment of symptomatic vitreomacular adhesion (sVMA) and in Europe for the treatment of vitreomacular traction (VMT; considered to be equivalent to sVMA) including when associated with macular hole (MH) of diameter ≤400 µm.
An evaluation of spontaneous AE reports submitted to regulatory authorities worldwide during routine pharmacovigilance was conducted. The ocriplasmin safety database, which includes all AEs reported since first approval on 17 October 2012 up to 16 October 2013, was searched using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. The 1-year time-span consisted of two separate reporting periods: Reporting Period 1 (RP1), 17 October 2012 to 16 April 2013; and Reporting Period 2 (RP2), 17 April 2013 to 16 October 2013.
An AE was reported for 284 of ~6903 eyes treated with ocriplasmin 125 µg (4.1 cases per 100 doses). Visual impairment was reported for 128 patients (1.85 cases per 100 doses). This included 94 events in 4704 eyes injected during RP2 (2.00 events per 100 doses), of which 20 events (0.43 events per 100 doses) were considered serious. Overall, dyschromatopsia was experienced by 27 patients, a frequency of 0.39 cases per 100 doses. During RP2, 18 patients experienced 19 events; two events (0.043 events per 100 doses) were considered serious and 17 (0.36 events per 100 doses) non-serious. Thirteen patients (0.19 cases per 100 doses) experienced impairment of the pupillary reflex within 5 days of injection. At the time of reporting, three cases were resolved, two were resolving, three were unresolved and the outcome of five was unknown. Overall, 19 patients (0.28 cases per 100 doses) experienced retinal tear/detachment, three patients (0.04 cases per 100 doses) experienced electroretinogram (ERG) changes, and one patient experienced lens subluxation (0.01 cases per 100 doses). Optical coherence tomography (OCT) changes and retinal vessel events were reported for 14 patients (0.20 cases per 100 doses) and two patients (0.03 per 100 doses), respectively.
The results reported here indicate that the safety profile of ocriplasmin in clinical practice remains consistent with that observed in the phase III studies. Visual impairment and dyschromatopsia were the most frequently reported AEs, and the vast majority of these events were considered to be non-serious. The frequencies of other reported AEs were generally low. The safety profile of ocriplasmin in ‘real-world’ clinical practice continues to be evaluated through routine pharmacovigilance activities and as part of the ongoing INJECT (Investigation of JETREA® in Patients with Confirmed Vitreomacular Traction) study. This is a global patient registry in which patients will be treated with ocriplasmin according to the approved indication in each country. The study aims to enroll 1500 patients across ~120 centres and will incorporate 12 months of patient follow-up.