Kowa Submits IND Application to the FDA to Begin Phase 2 Study of Ripasudil Hydrochloride Hydrate

Source: Kowa

Kowa, which has been developing Ripasudil Hydrochloride Hydrate, a Rho kinase inhibitor, for the indication of corneal endothelial diseases, submitted an investigational new drug (IND) application to the FDA on August 30, 2019 in order to commence a phase 2 clinical study in the US.

This drug was launched in December 2014 in Japan under the brand name Glanatec) ophthalmic solution 0.4%) as the world’s first glaucoma drug with Rho kinase inhibitory activity, and it was approved in February 2019 in Korea.

In the FDA study, Kowa will investigate the efficacy and safety in patients with corneal endothelial diseases. Kowa had previously acquired an exclusive license from Senju Pharmaceutical for a development of an ophthalmic solution for this disease: Glanatec ophthalmic solution 0.4%

Glanatec ophthalmic solution 0.4% includes this substance, which was licensed from D. Western Therapeutics Institute (DWTI) to Kowa, as an active ingredient. The drug lowers IOP by promoting discharge of aqueous humor through a main outflow via trabecular meshwork-Schlemm canal as a result of Rho kinase inhibition, according to a company news release.

In clinical studies enrolling patients with primary open-angle glaucoma and ocular hypertension in Japan, Glanatec ophthalmic solution 0.4% has been demonstrated to be effective in lowering IOP in both cases of monotherapy and conjunctival therapy along with conventional treatment-glaucoma and ocular hypertension drugs.


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