Last month, Bausch + Lomb and Nicox S.A. announced that the United States FDA approved the New Drug Application for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), the first prostaglandin analog with one of its metabolites being nitric oxide (NO). Vyzulta is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
According to a company statement, “following topical administration, Vyzulta, a once daily monotherapy with a dual mechanism of action, works by metabolizing into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm’s canal. The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain, and instillation site pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can occur.”
“Vyzulta represents the first FDA-approved therapy developed through our proprietary NO-donating research platform,” said Michele Garufi, chairman and CEO of Nicox, in recent a press release. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”
For more information, visit www.bausch.com .
In other news ...
- In October, Belgium-based iSTAR Medical announced that it has completed enrollment in its first-in-human trial for the MINIject, a micro-invasive glaucoma surgery device. The prospective, open, international, multicenter trial will be conducted on 25 patients with mild to moderate open-angle glaucoma uncontrolled by topical hypotensive medications and will assess the safety and performance of the MINIject, as measured by IOP reduction under medication from baseline to 6 months. Subsequent safety and performance measures will be taken at 12 and 24 months, according to iStar.
- Nicox and Re-Vana Therapeutics will team up to explore a drug delivery platform to lower IOP. The non-exclusive collaboration will focus on developing Re-Vana’s EyeLief drug delivery platform for sustained release of new stand-alone nitric oxide-donors developed by Nicox. EyeLief is a novel sustained-release, photo-crosslinked, preformed, biodegradable eye implant intended to release therapeutics over an extended period of time.