Lantibio

Development of Sodium Hyaluronate 0.18% Ophthalmic Solution for Dry Eye Disease

A proprietary ophthalmic formulation of sodium hyaluronate 0.18%, known as Vismed®, is currently marketed in territories of Europe and Asia under the CE mark as a viscoelastic lubricant eye drop. The proprietary formulation contains a highly purified specific fraction of sodium hyaluronate derived by fermentation from bacteria. Sodium hyaluronate is a natural polymer which is also present in the structures of the human eye. Its main physical characteristic is viscoelasticity. Therefore, this formulation of sodium hyaluronate ophthalmic solution has a high viscosity between blinks and a low viscosity during blinking ensuring efficient coating of the surface of the eye. It is believed that this protective coating of the surface of the eye helps prevent dryness and irritation. Sodium hyaluronate also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucus glycoprotein. This, together with the coating properties of sodium hyaluronate, results in an increased pre-corneal residence time and tear film break-up time (BUT) and therefore longer lubrication of the eye surface. The product is completely free from preservatives, which are known to cause toxic or allergic reactions, the symptoms of which include stinging, burning and redness of the eyes. As a result, it is non-irritating to ocular tissues and can be used frequently and for extended periods without harming the surface of the eye (e.g. without causing superficial punctate keratitis).

To maximize tolerability, solutions instilled into the eye should be neutral or slightly alkaline. Accordingly, to further maximize patient comfort, the pH of the product is adjusted to 7.3, similar to that of the natural tear film.

Hydrogels of sodium hyaluronate have been used for many years in ophthalmic surgery in Europe and the U.S. to maintain the shape of the eye, to cover surgical instruments and to protect the corneal endothelium from damage. They have unique physical properties that make them ideal for use in the treatment of dry eye disease.

This proprietaty formulation of sodium hyaluronate 0.18% ophthalmic solution represents a new class of compound in development for the treatment of dry eye in the US, offering properties which can alleviate the discomfort and reverse ocular damage caused by dry eye disease.

A Phase 3 pivotal efficacy trial, RP-001, was completed in the US in Q2 2008 in support of a New Drug Application (NDA), which was submitted to FDA in January 2009. Lantibio received an approvable letter on July 21, 2009 and is evaluating FDA's request for an additional study.