ATLANTIC CITY, N.J. — A newly approved drug is poised for on-label clinical use in patients with vitreomacular adhesion, a speaker said here.
Julia A. Haller, MD, OSN Retina/Vitreous Board Member, reviewed clinical trial results for Jetrea (ocriplasmin, ThromboGenics) at the Current Concepts in Ophthalmology meeting.
Julia A. Haller
The U.S. Food and Drug Administration approved ocriplasmin in October 2012. Ocriplasmin, the first drug indicated for symptomatic vitreomacular adhesion, induces posterior vitreous separation. Its commercial launch is Jan. 14.
“We are moving very excitingly into a new era of pharmacologic intervention in vitreomacular disease,” Haller said.
Early phase 2 studies showed that ocriplasmin was well-tolerated and yielded a discernible biologic effect, Haller said.
Results of the randomized phase 3 MIVI-TRUST study, with 219 patients assigned to receive ocriplasmin and 107 patients assigned to receive placebo, showed that almost 30% of patients had non-surgical resolution of focal adhesion at 28 days, Haller said.
Non-surgical closure of full-thickness macular hole was the real success story, Haller said.
Researchers have long sought the “holy grail of non-surgical management of vitreomacular pathology,” she said, and the advent of ocriplasmin heralds a “new era of pharmacologic intervention in vitreomacular disease.”
“We can start to explore diseases previously not well understood, not just macular hole and vitreomacular traction, but perhaps also multifactorial disease processes where not having that vitreous scaffolding might be an advantage to patients, particularly high-risk patients with macular degeneration or patients with diabetic retinopathy,” Haller said.
According to a ThromboGenics news release, the price of ocriplasmin will be set at $3,950 per vial.
Disclosure: Haller is a consultant/advisor for Alcon, Genentech, Regeneron, Second Sight and ThromboGenics.