A topical ocular cetirizine formulation has gained US Food & Drug Administration (FDA) New Drug Application approval for treating allergic conjunctivitis. Zerviate (cetirizine ophthalmic solution 0.24%) was developed by ophthalmic research and development company Nicox. The new topical medication provides patients with allergies with a new treatment option to alleviate the uncomfortable symptoms of allergic conjunctivitis. Michele Garufi, chairman and chief executive officer of Nicox, described the approval of the drug as a "huge milestone" for the company.
Cetirizine is a commonly used antihistamine used to treat hay fever, allergies and reactions. It is available as a generic, but is also the main active component in the branded antihistamine Zyrtec. The new ocular formulation will be used to help patients alleviate symptoms associated with allergic conjunctivitis, such as swelling, itching, watery eyes, blurred vision, sensitivity to light and redness.
In a statement, Nicox said: "Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with world-wide exposure representing more than 300 million patient-years." Other drugs used to treat patients with allergic conjunctivitis include corticosteroids like prednisone, and other antihistamine medications such as Phenadoz (promethazine) and Benadryl (diphenhydramine).
Allergic conjunctivitis, also known colloquially as pinkeye, is caused by a reaction to allergens, including: pollens from trees, plants and grasses, dust mites, and dander from pets. Patients already prone to allergic conditions are more likely to develop the condition, which is more prevalent during the time summer and when pollen counts are high. Studies suggest more than 75 million people suffer from the condition in the US alone.
The recommended dosage and administration of Zerviate is one drop in each affected eye twice daily, with each application at least eight hours after the previous. The drug was evaluated for efficacy in three clinical trials, which evaluated onset and duration of symptoms in patients given Zerviate and patients given a placebo.
The Nicox medication is not the first allergy treatment to gain FDA approval in 2017. In March this year, the government body approved Merck's Odactra for treating house dust mite-induced nasal inflammation (allergic rhinitis), providing an alternative treatment to allergy shots for patients suffering due to dust mite allergies.
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