Bausch + Lomb and NicOx resubmit US NDA for novel glaucoma candidate

28 February 2017
nicox-big

Bausch + Lomb, a wholly-owned subsidiary of Canada’s Valeant Pharmaceuticals International (TSX: VRX) and French biotech firm NicOx (Euronext Paris: COX) have re-submitted  a New Drug Application to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%.

Last July, the FDA delayed approval of the drug, proposed trade name Vesneo, issuing a Complete Response Letter that identified deficiencies in the manufacturing of the compound following a current Good Manufacturing Practice inspection at the Florida manufacturing facility of Bausch + Lomb.

Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT). The data submitted in the NDA support latanoprostene bunod as the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical