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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