Archive for March 5th, 2025

What information is needed for Ocugen’s BLA for OCU400?

Ocugen’s lead product is OCU400, a gene therapy that treats retinitis pigmentosa (RP) and Leber congenital amaurosis. OCU400 is a modifier gene therapy that aims to improve vision by resetting the retina’s gene network.  How OCU400 works OCU400 delivers a functional copy of the NR2E3 gene to the retina. NR2E3 regulates functions like photoreceptor development, metabolism, and […]

Are nitrosomamine impurities a hot topic?

Yes, nitrosamine impurities have been a significant and hot topic in the pharmaceutical industry and regulatory circles in recent years. Nitrosamines are a class of chemical compounds that can be potentially carcinogenic, and their presence in pharmaceutical products has raised serious safety concerns. Key Points of Concern: Regulatory Focus: Regulatory agencies such as the U.S. […]