Good news for people with allergic conjunctivitis, particularly those experiencing multiple ocular allergies in a year. A new drug for ocular itching may soon hit the market before 2016 ends.

Nicox S.A. announced yesterday the submission of the new drug dossier to the FDA. If approved by the FDA, the drug — AC-170 — is likely to hit the market by the end of 2016. In a press release issued today, Nicox has announced submission of clinical pediatric data as well as a request for Priority Review with the FDA.

“The submission of the first US NDA resulting from our acquisition of Aciex in October 2014 is a major milestone in the Company’s history,” stated Michele Garufi, the Chairman and Chief Executive Officer of Nicox.

The approval of the new drug will be a benchmark for the renowned pharmaceutical company as well as signification addition to the list of existing opthalomogical drugs and formulations. Since its inception, Nicox has been known for innovation in ocular drug formulations. The company, as per the director, is committed to delivering new ophthalmology treatment options to the patients.

“If successful in obtaining Priority Review, we would have two compounds – AC-170 and latanoprostene bunod, licensed to Bauch+Lomb, – potentially receiving FDA approval in the United States by the end of 2016,” continues Michele Garufi.

Indeed, this would be a remarkable and an almost unique achievement for the company. An approval from the FDA would thrust Nicox to the forefront of the leading biotechnology companies in Europe.

Michael Bergamini, Chief Scientific Officer and Executive Vice President of Nicox, commented, “AC-170 is the first ocular product which utilizes the well-known antihistamine cetirizine.”

The safety and efficacy of Cetrizine is widely recognized by physicians. With an approval from the FDA, the company aims to serve the 75 million Americans suffering from allergic conjunctivitis.

Prior to the dossier submission, Nicox held two meetings with the FDA updating the Agency on the drug’s clinical development as well as its chemistry, manufacturing, processing and the controls. It was then the FDA recommended submission of the NDA.

The FDA will review AC-170 under Section 505(b)(2) regulatory pathway enabling Nicox to rely on the Agency’s prior safety and efficacy findings for Cetrizine and its published literature. Nicox eyes a milestone profit of $35 million if the drug is approved prior to December 1st, 2016. A later approval, however, will cut the profit to $10 million.

Nicox is the name synonymous with novel ocular pharmaceuticals and devices to enhance our eyesight. Over years, it has built the reputation of a pharmaceutical giant in the ophthalmic industry. With AC-170 in the market, the individuals with repetitive complaints of ocular allergies can sigh in relief. Indeed, something to look forward to.

What is AC-170?

AC-170 is a brand new formulation of Cetrizine – a second-generation antihistamine and mast cell stabilizer. What is novel about AC-170 is that the company has introduced the first ever topical formulation of the drug. Until now, the drug was available in the oral dosage form. Cetrizine is used for the treatment of ocular itching, watery eyes, swelling and redness associated with allergic conjunctivitis.

Allergic conjunctivitis or the pink eye, as the name depicts is an allergic reaction that triggers conjunctivitis – or the inflammation of the thin layer of tissues lining the white surface of the eye and the eyelids (conjunctiva). Conjunctivitis is one of the most common eye diseases in the world affecting children and adults alike. In the US alone, allergic conjunctivitis affects more than 75 million people per year.

Conjunctivitis can occur alone or be triggered by a viral or bacterial infection. It can affect either or both eyes simultaneously. The signs and symptoms of conjunctivitis include:

  • Watery eyes
  • Itching in the eyes
  • Burning in the eyes
  • Blurred vision
  • Sensitivity to the light

Cetrizine binds competitively to the histamine receptors in the body where it prevents the release of histamine – the natural chemical in the body that plays a role in activating body’s defense mechanism in the form of sneezing, itching, watery eyes and runny nose.

Cetrizine, the active ingredient of the Zyrtec®, has been available in the market as an approved oral drug for a decade and a half (2009). It has a well-documented safety and efficacy profile. Each year, more than 300 million patients are reported to take Cetrizine for allergies.

Two US patents cover AC-170 having expiries in 2030 and 2032 respectively.

The press release further describes submission of two Phase 3 safety and efficacy trials for AC-170. In each trial, conjunctival allergen challenge (CAC) model of allergic conjunctivitis has been used. The collective results of both trials have been encouraging, demonstrating statistically significant results for the primary endpoint – ocular itching.

AC-170 was developed by Aciex Therapeutics, Inc, a subsidiary of Nicox that was subsequently renamed Nicox Ophthalmics, Inc in 2014.