PubMed Health. A service of the National Library of Medicine, National Institutes of Health.

Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection): For the Treatment of Symptomatic Vitreomacular Adhesion [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan.

EXECUTIVE SUMMARY

Introduction

Symptomatic vitreomacular adhesion (sVMA) is a rare macular condition caused by an incomplete posterior vitreous detachment of the vitreous from the macula,1 potentially resulting in irreversible vision loss and blindness if left untreated.2 Ocriplasmin is a recombinant, truncated form of human plasmin obtained from microplasminogen produced in a Pichia pastoris expression system by recombinant DNA technology.3 The recommended dosage is a single 125 mcg intravitreal injection. Repeated administration of ocriplasmin in the same eye is not recommended. The treatment solution should be diluted by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%). If treatment in the contralateral eye is required, it should not be performed within seven days of the initial injection in order to monitor the post-injection course and the potential for decreased vision in the injected eye.3

Indication under review
For the treatment of symptomatic vitreomacular adhesion
Listing criteria requested by sponsor
As per indication for single-use only (subsequent injections in the same eye will not be covered) and diagnosis should be confirmed through optical coherence tomography

The objective of this report is to perform a systematic review of the beneficial and harmful effects of ocriplasmin for the treatment of sVMA.

Results and Interpretation

Included Studies

Three multicentre, randomized, parallel group, double-mask, placebo and sham-controlled studies met the inclusion criteria for this systematic review. TG-MV-0064 (N = 326) and TG-MV-0075 (N = 326) were identically designed phase III studies which evaluated the safety and efficacy of a single 125 mcg dose injection of ocriplasmin compared with placebo injection for the treatment of sVMA. TG-MV-0046 (N = 60) was a phase II study which evaluated the safety and preliminary efficacy of ocriplasmin 75 mcg, 125 mcg, 175 mcg single doses and repeated doses of ocriplasmin 125 mcg (up to two additional open-label injections) compared with a sham injection. Given the numerous limitations of TG-MV-004 pertaining to this report, data from this study are not presented or discussed. Thus, the two phase III studies, TG-MV-006 and TG-MV-007, served as the primary demonstration for efficacy and safety in this report. The primary outcome in TG-MV-006 and TG-MV-007 was proportion of patients with VMA resolution, determined by a masked central reader center (CRC) interpreting optical coherence tomography (OCT) at day 28.

Efficacy

In both studies, ocriplasmin revealed statistical superiority over placebo for the achievement of VMA at day 28, 3 months and 6 months. The between-group difference of patients achieving resolution of VMA with ocriplasmin versus placebo was greater in TG-MV-007 at day 28 (19.1%) compared with TG-MV-006 (14.8%). Similar results were seen at 3 months and 6 months. The proportion of patients who achieved resolution of VMA was similar at all follow-up periods for the ocriplasmin groups in both studies. In TG-MV-006, the placebo group had a greater proportion of patients achieving resolution of VMA at day 28, 3 months, and 6 months, compared with TG-MV-007.

Harms

The overall incidence of adverse events (AEs) in both studies was greater when patients were treated with ocriplasmin, with an AE rate approximately twice that observed with placebo. The incidence of serious adverse events (SAEs), withdrawal due to adverse events (WDAEs) and notable harms did not differ significantly between the ocriplasmin and placebo groups in both studies. Occurrences of notable harms such as lens subluxation, cataracts, eye infection, retinal detachment, vitritis, retinal hemorrhage, and vitreous hemorrhage were relatively rare; however, conjunctival hemorrhages were more common.

Conclusions

Two multicentre, randomized, parallel group, double-masked, placebo-controlled studies comparing a single 125 mcg intravitreal injection of ocriplasmin with a placebo injection for the treatment of VMA were reviewed. Overall, treatment with ocriplasmin was superior to placebo for the resolution of VMA and total posterior vitreous detachment (PVD). Although there was a greater overall incidence of AEs for patients treated with ocriplasmin compared with placebo, many events were transient and possibly related to the procedure instead of the drug itself. There is uncertainty regarding the efficacy of ocriplasmin for the treatment of full-thickness macular holes (FTMHs), avoidance of vitrectomy, and improvement in best-corrected visual acuity (BCVA). Moreover, no data were available on whether ocriplasmin prevents VMA-related vision loss or blindness, a key outcome according to patient groups.

Copyright © CADTH 2014.

You are permitted to make copies of this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. You may not otherwise copy, modify, translate, post on a website, store electronically, republish, or redistribute any material from this document in any form or by any means without the prior written permission of CADTH.

Please contact CADTH’s Vice-President of Corporate Services at ac.htdac@secivresetaroproc with any inquiries about this notice or other legal matters relating to CADTH’s services.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Cover of Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection)
Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection): For the Treatment of Symptomatic Vitreomacular Adhesion [Internet].

PubMed Health Blog...

read all...

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...