This article is more than 5 years old. Information may no longer be current.

ThromboGenics to initiate post-marketing trial of Jetrea

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

ThromboGenics plans to initiate a U.S. phase 4 study of Jetrea this month, according to a press release.

The Ocriplasmin Research to Better Inform Treatment (ORBIT) study will generate more data on the real-world use of Jetrea (ocriplasmin).

The prospective, observational study will recruit 1,500 patients with symptomatic vitreomacular adhesion or vitreomacular traction across 120 U.S. retina centers and assess clinical outcomes and safety of Jetrea administered in a real-world setting through anatomical and functional outcomes.

Primary outcome measures will include resolution of VMA, full-thickness macular hole closure, changes in visual acuity, and occurrence and time to vitrectomy, the release said.

Adverse drug reactions and changes in ocular signs and symptoms from baseline will also be evaluated.

Patients will be followed for up to 12 months.

The study is expected to start recruiting patients later this month. Its estimated completion date is mid-2016.

In a separate press release, ThromboGenics announced that its board of directors is exploring strategic options to increase the company’s ability to commercialize Jetrea in the U.S. Morgan Stanley has been retained to help with the strategic review process.