Ocugen: FDA Accepts Application to Begin Trial of OCU400 in Retinitis Pigmentosa
December 09 2021 - 8:37AM
Dow Jones News
By Michael Dabaie
Ocugen Inc. said the U.S. Food and Drug Administration accepted
its Investigational New Drug application to initiate a clinical
trial of OCU400 in retinitis pigmentosa.
The biopharmaceutical company focused on gene therapies to cure
blindness diseases, said the trial, to start in the first quarter
of 2022, will enroll patients with mutations in NR2E3 or RHO
genes.
Ocugen shares were up 4% to $6.28 in premarket trade.
"We're collaborating with leading centers in eye care and have
been vital partners to getting our trial launched and receive
patients. With this final decision by the FDA, we are embarking on
a new pathway of care through this innovative gene therapy," said
Chief Executive Shankar Musunuri.
OCU400 was granted four orphan drug disease designations from
the FDA for treating four different gene mutation-associated
retinal degenerative diseases between 2019 and 2020. The European
Medicines Agency granted Ocugen broad orphan medicinal product
designation in 2021 for OCU400 for the treatment of both retinitis
pigmentosa and Leber congenital amaurosis.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 09, 2021 08:22 ET (13:22 GMT)
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