Santen now MA holder for Rhokiinsa and Roclanda in the EEA and UK

Japan-headquartered ophthalmology specialist Santen Pharmaceutical (TYO: 4536) has received approval for the transfer of the Marketing Authorization of the rho kinase inhibitors (ROCK inhibitors) Rhokiinsa (netarsudil 200mcg/ml eye drops, solution) and Roclanda (latanoprost 50mcg/ml and netarsudil 200mcg/ml eye drops, solution) in the European Economic Area (EEA) from the European Medicines Agency (EMA) and in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA).

Netarsudil is the first novel molecule in glaucoma in 25 years and the only molecule to target the trabecular meshwork of the eye. In open-angle glaucoma, the trabecular meshwork degenerates leading to stiffness and a build-up of aqueous humour within the anterior chamber of the eye resulting in elevated intraocular pressure. Netarsudil works by relaxing the trabecular meshwork, increasing trabecular outflow and increasing the diameter of episcleral veins, thus lowering the episcleral venous pressure and increasing the outflow of aqueous humor. Latanoprost, meanwhile, increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.

This news follows Santen’s recent exclusive development and commercialization agreement with US firm Aerie Pharmaceuticals (Nasdaq: AERI) to expand its glaucoma portfolio in  Europe, Middle East and Africa (EMEA) to include Rhokiinsa and Roclanda. Santen can now proceed with full Marketing Authorization Holder (MAH) responsibilities and start working towards making these ROCK inhibitors available for patients with primary open-angle glaucoma or ocular hypertension in the EMEA region.