French Biotech submits new Drug for Eye Allergies to the FDA

20/04/2016 - 2 minutes

Nicox is filing a New Drug Application for its allergic conjuntivitis candidate, a novel eye drop formulation of a well-known antihistamine.

nicox_allergic_conjunctivitis_acBased in Sophia Antipolis (near the French Riviera), Nicox is developing therapies in ophthalmology.

Now, it has submitted one of its candidates (AC-170) for FDA approval, after good results from two phase III trials evaluating both the safety and efficacy in patients with allergic conjunctivitis.

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). 

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