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

FDA approves request for phase 3 of T-PRK study

Issue: October 1996

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

ORLANDO, Fla. — The Food and Drug Administration (FDA) last month cleared Autonomous Technologies Corporation's tracker-assisted photorefractive keratectomy (T-PRK) for a 500-patient, 7-site phase 3 clinical trial for treating between 1 D and 7 D of myopia.

The FDA cleared the phase 3 trials within 30 days of receiving the application and phase 2 data from Autonomous, according to a company press release.

Data from the phase 2 trials conducted on 180 patients in New Orleans and Crete, Greece, showed that 77% of patients achieved 20/20 vision, while all patients achieved 20/40 or better vision.

No patients lost more than two lines of best corrected visual acuity at 6 months.