Lux Biosciences, a privately held biotechnology company focused on the treatment of ophthalmic diseases, has raised $4 million of $4.35 million it has sought in its latest round of fundraising, according to a Form D filing with the U.S. Securities and Exchange Commission.
The company has raised more than $64 million in a series of offerings since June 2009.
Last year, the Jersey City, New Jersey company received a complete response letter from the U.S. Food and Drug Administration following its submission of its New Drug Application for Luveniq (oral voclosporin), for the treatment of noninfectious uveitis, developed in collaboration with Isotechnika Pharma. A complete response letter is issued when the regulator has outstanding questions or issues that the drug makers need to resolve.
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Uveitis is a swelling of the middle layer of the eye that supplies most of the blood to the retina. Although it can affect people with autoimmune disorders or rheumatoid arthritis, it can affect healthy people as well and cause permanent vision damage, even with treatment.
Acknowledging the letter, Lux Biosciences CEO Dean Mitchell said in an August 2010 statement it would commence additional clinical trials to address questions raised by the FDA: “We continue to work with FDA to address their outstanding questions regarding the safety and efficacy of Luveniq, and the Lux Biosciences’ board of directors is supportive of our starting the additional trial. At the same time, the European Medicines Agency review of the Marketing Authorization Application for Luveniq remains on course for completion in the first quarter of 2011.”
In October, Lux Biosciences withdrew its application for marketing approval for Luveniq in Europe following a negative review by the European Medicines Agency Committee for Medicinal Products for Human Use in June.
Its pipeline includes a topical drug, LX 214, for the treatment of moderate dry eye in phase 1 clinical trials. It is also doing research for implant LX212 for severe dry eye.
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