• NCX 4251 is a novel therapy in development for blepharitis, administered via a novel route of delivery directly to eyelid margin, where blepharitis originates

  • Preclinical data supports dose ranging in Phase 2 clinical study up to the highest tested dose

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a poster presentation at the American Glaucoma Society (AGS) 2019 Annual Meeting showing preclinical evaluation of a novel blepharitis therapy, Nicox’s product candidate NCX 4251, with a novel route of delivery, which is administered directly to the eyelid margin, where blepharitis originates.

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.

All doses tested in preclinical evaluations demonstrated excellent safety and tolerability, and no intraocular pressure (IOP) elevations were observed in the course of the preclinical studies. The preclinical data fully supports dose ranging in Phase 2 study up to the highest tested dose.

The AGS 2019 Annual Meeting took place on March 14-17, 2019 in San Francisco.

About NCX 4251

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals which is being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. Blepharitis is a common eye condition characterized by eyelid inflammation. It is being developed for application via a swab at the eyelid margin, applied directly to the site of inflammation thereby minimizing potential penetration of the drug through the cornea which can lead to the damaging side effects, such as IOP increase, found with current topical steroids.

Fluticasone propionate, the active ingredient in NCX 4251, which has not previously been approved in a topical formulation for use in ophthalmology, has an affinity for the glucocorticoid receptor which is approximately ten times greater than dexamethasone, a corticosteroid commonly used in ophthalmology. Fluticasone is a glucocorticoid with potent anti-inflammatory properties that has been approved in numerous drug products over the past 20 years for the treatment of various indications including dermatology, rhinitis and asthma.

Poster details

Title: Nonclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Improve Efficacy and Reduce the Potential for IOP Elevations

Presentation date: March 15, 2019

Presenters: Robert Fechtner, MD; Tomas Navratil, PhD; Jean-Michel Bukowski, PhD; Frederic Pilotaz, PharmD; Amanda Graves; Akshay Nadkarni; Brigitte Duquesroix, MD; Angela Kothe, PhD, OD; Michael Bergamini, PhD; Harvey DuBiner, MD; Thomas Walters, MD; Donald Budenz, MD.