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The time-course and resolution of key adverse events in the ocriplasmin clinical trial programme

Session Details

Session Title: Miscellaneous

Session Date/Time: Saturday 13/09/2014 | 11:00-13:00

Paper Time: 11:24

Venue: Boulevard E

First Author: : P.Lanzetta ITALY

Co Author(s): :                  

Abstract Details

Purpose:

A thorough understanding of the safety profile associated with ocriplasmin treatment is important for assisting physicians with management decisions and for ensuring the appropriate level of patient education. Here, we present an overview of safety outcomes from the ocriplasmin clinical trial programme, with specific focus on the time-course and resolution of key adverse events (AEs).

Setting:

The AE profile for patients enrolled in the ocriplasmin phase II and III studies was evaluated. The majority of patients received a single 125 μg intravitreal injection of ocriplasmin, however, in Phase II studies, doses ranged from 25–175μg.

Methods:

An analysis of the incidence, time to onset and time to resolution of a number of key events was conducted. Evaluated events included: acute visual acuity (VA) decrease, defined as a ≥2-line best-corrected visual acuity (BCVA) decrease from baseline between Days 0 and 7 after injection; dyschromatopsia; and electroretinogram (ERG) changes. ERG changes and dyschromatopsia were not prospectively investigated in all studies.

Results:

Overall, 652 patients were enrolled in the phase III studies (ocriplasmin, n=465; placebo, n=187). Between Days 0 and 7, ocular AEs occurred more frequently in ocriplasmin-treated patients versus those receiving placebo. However, from Day 8 to Month 6, incidences of these AEs were similar in both groups. Acute VA decrease was more frequent in ocriplasmin-treated patients (36/465; 7.7%) than in those receiving placebo (3/187; 1.6%). These events were mostly transient and, by Month 6, 30/36 (83.3%) ocriplasmin-treated patients had achieved visual recovery to within 5 letters of baseline values, compared with 1/3 (33.3%) patients in the placebo group. Of 820 ocriplasmin-treated patients in the phase II/III studies, nine (1.1%) experienced a transient and serious/severe reduced VA, within 24–48 hours after injection. Eight of these cases resolved within a median of ~14 days. Ten patients experienced ERG abnormalities, of which six cases resolved within a median of 6 months. Sixteen cases of dyschromatopsia were reported (2.0%); eight of these patients also experienced ERG changes. The median time to onset was 1 day, and 14 cases resolved within a median of 3 months. One case each of lens subluxation and phacodonesis were also noted.

Conclusions:

The majority of ocular AEs experienced by patients treated with ocriplasmin during the phase III studies occurred within the first 7 days after injection, with a similar incidence of events in the ocriplasmin and placebo groups from Day 8 onwards. Overall, reported AEs were mainly transient in nature, with most resolving before the end of the study. In the ERG and dychromatopsia cases in which resolution of AEs was not observed, the majority of patients were lost to follow-up before the end of the study. It is important that patients are educated about the potential AE profile of ocriplasmin treatment, including the anticipated duration and time to resolution of events, based on the available evidence from clinical studies. Further monitoring of the safety profile of ocriplasmin is needed through routine pharmacovigilance and in on-going studies.

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