Santen receives manufacturing and marketing approval for the dry-eye treatment Diquas LX ophthalmic solution 3% in Japan
Diquas LX Ophthalmic Solution 3% is a formulation that requires the administration of one drop at a time, 3 times daily, an improvement over the current dosage: one drop at a time, 6 times daily, which has been launched in Japan since 2010. One of the factors that causes patients to fail to adhere to administration requirement for eye drops in ophthalmic dry-eye treatment is the large number of times the eye drops must be used daily. Developing Diquas Ophthalmic Solution that requires lower administration frequency is clinically beneficial and reduces the burden of patients.
The active ingredient, diquafosol sodium, is a P2Y2 receptor agonist that acts on conjunctival tissues to promote the secretion of tears containing water and secretory mucins. It also has the effect of promoting the expression of membrane-bound mucins on corneal epithelium. In addition to these effects, Diquas LX Ophthalmic Solution 3% boosts the lipid content in tears to quantitatively and qualitatively improve tear abnormalities, and bring the ocular surface to a normal condition to demonstrate an efficacy.
Diquas LX Ophthalmic Solution 3% was verified as being superior to placebo eye drops in Phase III clinical trial covering Japanese dry-eye patients, in which the score for corneal epithelial staining from fluorescein was used as the indicator to determine the level of improvement for corneal epithelial disorders and in Phase IIIb clinical trial, the eye drop adherence rate was higher than that of the existing Diquas Ophthalmic Solution 3%. In both Phase III and Phase IIIb clinical trials, no serious ocular or systemic side effects were observed.
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