Ocugen wins orphan drug status for ocular gene therapy

The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease.
The Malvern, Penn.-based company’s OCU400 product includes an adeno-associated virum serotype 5 capsid that contains the gene for human nuclear hormone receptor NR2E3.
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Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance ocugen Source Type: news