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

InnFocus gets financing, FDA authorization for MicroShunt study

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

The U.S. Food and Drug Administration has granted authorization to InnFocus to begin a phase 1 trial of its MicroShunt device to treat open-angle glaucoma, according to a news release.

InnFocus also received $13.4 million in financing from HOYA Group and Saints Capital Everest, the release said.

In its third year, a continuing study of the MicroShunt suggests the device is capable of lowering IOP by 50% to 60%, InnFocus President Leonard Pinchuk, MD, said in the release. The average IOP of recipients is between 10 mm Hg and 12 mm Hg, with approximately 90% of recipients below 14 mm Hg and a similar percentage who are completely off of glaucoma medications.

“The key to our success is our proprietary biomaterial, which demonstrates a clinically insignificant foreign-body reaction in the eye,” Pinchuk said.

The phase 1 trial will use trabeculectomy with mitomycin C as its control, according to the release.