FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results
The FDA is back to warning companies of $10,000 fines for failing to report the results of clinical trials, this time going after clinical stage biotech company Ocugen, known most recently for trying to bring a Covid-19 vaccine from India to the US and other markets.
The trial in question with FDA, completed in May 2019, was a Phase III study of brimonidine tartrate nanoemulsion eye drop to treat dry eye disease. The company said in an SEC filing in Nov. 2019 that the Phase III trial has completed “and although the study showed that OCU310 is well tolerated, as demonstrated by no adverse events regarding as ‘severe,’ it did not meet its co-primary endpoints for symptoms and signs.”
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