Nicox is filing a New Drug Application for its allergic conjuntivitis candidate, a novel eye drop formulation of a well-known antihistamine.
Based in Sophia Antipolis (near the French Riviera), Nicox is developing therapies in ophthalmology.
Allergic conjunctivitis is an inflammation of the eye and inner surface of the eyelids – causing redness and itchiness. The indication has an annual market worth over €700M, with 75 million patients in the US.
The disease is also quite common in children, and the pediatric results for AC-170 motivated Nicox to request a Priority Review. If this is granted, the candidate could be approved by end of 2016.
AC-170 is a novel eye-drop formulation of cetirizine, a compound already approved as an oral drug and commercialized as Zyrtec (by GSK). Cetirizine is a second generation antihistamine – a drug for allergies with fewer side effects in the nervous system, such as sedation.
The candidate was initially developed by Aciex (US), which was acquired by Nicox in October 2014. Depending on approval, ex-shareholders could be looking at a milestone payment of over €30M ($35M).
Besides its acquisition strategy, Nicox also relies on nitric oxide-donating research platform. Nitric oxide (NO) is an important cell-signaling molecule, and a deficiency in the compound is involved in some eye disorders.
One of Nicox’ NO-donors, latanoprostene bunod (licensed to German Bausch + Lomb), also has a new drug application (NDA) under review by the FDA.
So Nicox could have two drugs approved during 2016 – not a small feat.