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Journal of Drug Delivery
Volume 2012, Article ID 604204, 16 pages
http://dx.doi.org/10.1155/2012/604204
Review Article

Successfully Improving Ocular Drug Delivery Using the Cationic Nanoemulsion, Novasorb

1Research and Development Department, Novagali Pharma SA, 1 rue Pierre Fontaine, 91058 Evry Cedex, France
2The Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, POB 12065, 91120 Jerusalem, Israel

Received 7 September 2011; Accepted 9 November 2011

Academic Editor: Abhijit A. Date

Copyright © 2012 Frederic Lallemand et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Topical ophthalmic delivery of active ingredients can be achieved using cationic nanoemulsions. In the last decade, Novagali Pharma has successfully developed and marketed Novasorb, an advanced pharmaceutical technology for the treatment of ophthalmic diseases. This paper describes the main steps in the development of cationic nanoemulsions from formulation to evaluation in clinical trials. A major challenge of the formulation work was the selection of a cationic agent with an acceptable safety profile that would ensure a sufficient ocular surface retention time. Then, toxicity and pharmacokinetic studies were performed showing that the cationic emulsions were safe and well tolerated. Even in the absence of an active ingredient, cationic emulsions were observed in preclinical studies to have an inherent benefit on the ocular surface. Moreover, clinical trials demonstrated the efficacy and safety of cationic emulsions loaded with cyclosporine A in patients with dry eye disease. Ongoing studies evaluating latanoprost emulsion in patients with ocular surface disease and glaucoma suggest that the beneficial effects on reducing ocular surface damage may also extend to this patient population. The culmination of these efforts has been the marketing of Cationorm, a preservative-free cationic emulsion indicated for the symptomatic treatment of dry eye.