A missing assignment from Ocugen’s past has come back to haunt the clinical-stage biotech—and the issue could reveal deeper problems with the FDA’s clinical trial oversight, one nonprofit contends.
The FDA has warned Ocugen that it could face a $10,000 fine unless it turns over results from an eye drug study that wrapped up in May 2019. The trial was looking at the safety and efficacy of brimonidine tartrate nanoemulsion in patients with dry eye disease.
Ocugen, which is developing gene therapies to tackle ocular diseases, has recently elevated its profile in the biopharma industry. Chalk it up to the company’s role as the North American partner for Bharat Biotech’s COVID-19 vaccine Covaxin, which has run into problems of its own.
On the absent data, meanwhile, Ocugen told Fierce Pharma it had in fact updated the relevant study on ClinicalTrials.gov. The company is currently working with the regulator, a company spokesperson said.
In a November 2019 Securities and Exchange Commission filing, Ocugen confirmed it had completed the late-stage dry eye disease trial, which showed the drug—OCU310—was well tolerated but did not meet its co-primary endpoints “for symptom and signs.”
The FDA first flagged the missing data issue for Ocugen back in July, the agency said in its latest letter to the company.
Now, the clock is ticking down: Ocugen has 30 days from April 15 to hand in its data lest the FDA levy its fine and, potentially, “seek additional civil money penalties against [the] company.”
More specifically, Ocugen could ultimately be charged $10,000 each day it fails to submit the results after the initial 30-day window has closed.
Injunction or criminal prosecution could follow, too, the agency warned.
“Ocugen is committed to compliance and takes transparency regarding clinical trial data and trial reporting seriously,” an Ocugen spokesperson told Fierce Pharma over email. “We submitted information to update the site after the trial was completed.
“In November 2021, we updated the site with additional information, which is not reflected,” he added.
The company has been in talks with the regulator “ever since receipt of their letter and we will resubmit information as requested ahead of their deadline,” he said.
Meanwhile, Transparimed, a nonprofit that aims to “end evidence distortion in medicine,” took aim at the FDA’s sluggish response to the data delay.
The group questioned the time it took the FDA to contact Ocugen after trial results became overdue—more than a year—and further blasted the regulator for taking more than half a year to follow up on its initial communique. The nonprofit also wondered why the FDA singled out Ocugen’s OCU310 study given that three Ocugen studies appear overdue.
The problem is much bigger than Ocugen, Transparimed said. The nonprofit claimed there are at least 3,280 clinical trials currently missing results. Given that that’s a violation of the law, Transparimed wonders why the FDA hasn’t followed through with more companies.