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

Health Canada rejects license application for glaucoma treatment device

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

Health regulators in Canada asked for more data before considering approval of a glaucoma device. Health Canada asked Refocus Group to submit a larger sample size for its PresView device for the treatment of glaucoma and other ocular disorders, Refocus announced last week. Its initial application data was based on 24 patients.

Aaron Rifkind, MD, studied 24 patients with either primary open-angle glaucoma or ocular hypertension who underwent surgery with the PresView device. Follow-up was 2 years. Patients had a mean intraocular pressure decrease of 7.7 mm Hg overall, which was 1.1 mm Hg lower than the presurgery mean baseline value with the use of glaucoma medication.

Presbyopia was also analyzed in those patients, who experienced an overall four lines of vision improvement.

Refocus Group originally anticipated Canadian approval in the second or third quarter of this year. Refocus Group merged with Presby Corp. in March of this year and is working with CIBA Vision to commercialize PresView.