Belgian biotech ThromboGenics has gained the endorsement of FDA advisers for its experimental eye drug ocriplasmin as a treatment for vision-impairing vitreomacular adhesion. The FDA advisory committee echoed some of the safety concerns raised in an agency staff review earlier this week, but members ultimately voted 6-3 that no additional studies of the treatment's impact on the retina were needed prior to approval, Bloomberg reported.
Ocriplasmin offers a potential alternative to surgery for some patients with the eye condition, which leads to retinal distortion and vision loss, according to ThromboGenics. Yet the FDA staff review highlighted an increase in eye pain, vision problems and other side effects among patients on the drug compared with those on placebo in the company's trial, the news service reported. Though panelists harbored some concerns of their own, the majority of them viewed the treatment as a better option for some than surgery.
"I suspect the sponsor and the ophthalmology community will identify which patients will have a higher potential for benefit," Susan MacDonald, a panel member from the Lahey Clinic in Peabody, MA, said, as quoted by Bloomberg.
The FDA is expected to make a call on the U.S. marketing of ThromboGenic's biologic by October 17, taking action on the company's lead drug in a key territory. The company says that about half a million patients in the U.S. and Europe could benefit from ocriplasmin, which could become the first therapeutic approved for symptomatic vitreomacular adhesion. Novartis ($NVS) controls marketing rights to the drug outside of the U.S.
- here's the company's release
- see Bloomberg's article
- and Reuters' report