Studies of Sodium Hyaluronate 0.18% Ophthalmic Solution in Dry Eye Disease

Phase II/III Clinical Trials in Dry Eye Patients

The controlled clinical studies with a proprietary formulation of sodium hyaluronate 0.18% opththalmic solution, known as VISMED® in territories in Europe and Asia where it is marketed, have led to the following results:

Objective Signs;

corneal staining with fluorescein, staining with lissamine green, tear film BUT, and impression cytology of conjunctival cells were improved.

Subjective Symptoms;

Symptoms of pain, soreness, scratchiness, grittiness, burning, photophobia, comfort of the solution were improved.

The tear film osmolarity assessment also showed that the hypotonic formulation of VISMED® was efficient in counteracting the hypertonicity of tears in patients with dryness sensations.

VISMED® has been shown to reduce the healing time in patients with superficial punctate keratitis

VISMED® is safe and well-tolerated.  No adverse reactions have been observed by the investigators or reported by the patients.

Pivotal Phase 3 Study in the US; RP-001

A multi-center, Phase 3 pivotal trial of this proprietary formulation of sodium hyaluronate 0.18% ophthalmic solution, RP-001, was completed in the US in May 2008. This randomized, placebo-controlled study evaluated the efficacy and safety of the product, compared with its vehicle, for the treatment of the signs and symptoms of dry eye disease.

The results of RP-001, along with results from previous European studies, was supportive of the filing of a New Drug Application (NDA) in January 2009.

Complementary Animal and Human Data

Data acquired from animal and human studies to date show that the proprietary formulation of sodium hyaluronate is an effective way to deliver the compound to the surface of the eye safely. The historical profile of the product suggests that it will be safe to other organs and body systems, while offering direct benefit to the target organ.