Ocugen could face $10,000 FDA non-compliance fine

According to the FDA, Ocugen didn’t turn in its homework — and now the company is facing fines up to $10,000 per day.

The Pennsylvania-based biotech is in trouble after failing to submit clinical trial results for its phase 3 study of eye drops for patients with dry eye disease (DED). That study wrapped up in May 2019. 

The FDA first warned Ocugen last July via an emailed letter, alerting the company to its potential noncompliance and asking it to upload trial results within 30 days. According to the agency, Ocugen failed to submit results for the applicable trial.

Now, in its most recent letter, the agency has given Ocugen until May 15 to post results — or the company will be fined up to $10,000 each day it delays its report. The FDA has warned it may seek additional “civil money penalties” or legal actions like criminal prosecution if the biotech fails to post data.

The trial in question is a phase 3 trial of brimonidine tartrate nanoemulsion eye drops. In November 2019, Ocugen said the study showed the eye drop treatment was “well tolerated” and had no “severe” adverse events but it did not meet its primary endpoints for symptoms and signs.

But Ocugen is telling a different story. The company told media sources that it has already uploaded the relevant results to clinicaltrials.gov.