Nicox’s Positive FDA Meeting Shows Clear Path for NCX 4251 in Dry Eye

• Statistically significant and clinically relevant results were obtained for the reduction of dry eye symptoms in patients with moderate to severe dry eye disease in a post hoc analysis of the Phase 2b Mississippi clinical trial
• A path forward to develop NCX 4251 as a treatment for dry eye disease has been confirmed following a recent meeting with the United States Food and Drug Administration

February 8, 2022 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it will be focusing the future development of NCX 4251 on dry eye disease. This decision follows the encouraging post hoc results from the Mississippi Phase 2b clinical trial and a subsequent positive meeting with the U.S. Food and Drug Administration (FDA). The results, reported on November 30, 2021, suggest that once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, is effective in reducing dry eye symptoms in patients who score more highly for a key sign of dry eye disease.  

“Based on the Mississippi trial results and following a recent meeting with the United States Food and Drug Administration, we identified a clear route for the development of our NCX 4251 as a treatment for dry eye disease. The post hoc analysis of the Mississippi data shows that NCX 4251 has a statistically significant and clinically relevant effect over placebo on a number of dry eye symptoms, and an effect on a key sign of dry eye which approached statistical significance and that we believe would be statistically significant in a larger trial,” said Doug Hubatsch, EVP and Chief Scientific Officer of Nicox. “We are currently designing the next clinical trial with our clinical advisors and expect to initiate it in 2023.”

NCX 4251 profile

• Novel, patented nanocrystal suspension of fluticasone propionate, a steroid with affinity for the glucocorticoid receptor approximately ten times greater than dexamethasone
• Application of fluticasone propionate to the eyelid margins via an applicator minimizes potential steroid exposure through the cornea which can lead to damaging side effects such as intraocular pressure increase found with current topical steroids
• The convenience of once-a-day dosing may improve compliance and patient acceptance

Further pharmaceutical development activities will need to be completed to support the next steps in the clinical development of NCX 4251. The clinical trials are not currently financed, per the recently announced cash runway of Q4 2023.

Dry Eye Disease

Dry eye disease is a common condition that occurs when the quality and/or quantity of tears aren’t able to adequately hydrate or lubricate the eyes. This inadequate lubrication can lead to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Dry eye disease is estimated to impact around 34 million adults in the U.S. alone. The estimated worldwide market for dry eye disease treatment is over $5 billion.