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Santen confirmed as Marketing Authorisation Holder of Rhokiinsa® and Roclanda® in the EEA and UK after transfer from Aerie Pharmaceuticals

Mon 28 February 2022

For healthcare business and investor press only

Santen has now received approval for the transfer of the Marketing Authorisation (MA) of the rho kinase inhibitors Rhokiinsa® (netarsudil 200 micrograms/ml eye drops, solution) and Roclanda® (latanoprost 50 micrograms/ml and netarsudil 200 micrograms/ml eye drops, solution) in the European Economic Area (EEA) from the European Medicines Authority (EMA) and in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA). Santen can now proceed with full Marketing Authorisation Holder (MAH) responsibilities and start working towards making these rho kinase inhibitors (ROCK inhibitors) and their innovative mode of action available for patients with primary open-angle glaucoma or ocular hypertension in the region. Rhokiinsa® is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.1 Roclanda® is indicated for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.2

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 IOP.3 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 humour.3 Latanoprost, meanwhile, increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.4 Results from Mercury 3 – a phase III, non-inferiority trial to compare IOP reduction in patients with open-angle glaucoma or ocular hypertension using Roclanda® or a fixed dose combination of a prostaglandin analogue (PGA) and timolol (a beta blocker) – are pending publication.

“Despite being one of the leading causes of blindness and with a range of therapeutics available, people continue to suffer from glaucoma-related vision loss,” said Luis Iglesias, President and Head of Santen EMEA. “The prospect of ROCK inhibitors is exciting – they are for use at every stage of a glaucoma patient’s journey. They represent the first innovation in the field of medical glaucoma management in EMEA since 1996 and we have a great opportunity to be the leaders in glaucoma with this addition to our portfolio.”

The products are approved and being sold in the United States by Aerie Pharmaceuticals (“Aerie”) under the names Rhopressa® and Rocklatan®. In October 2020 Santen and Aerie entered into an exclusive development and commercialisation agreement for Rhopressa® and Rocklatan® in Japan, along with rights for several other Asian countries. On 7 December 2021, Santen announced the global expansion of its exclusive development and commercialisation agreement with Aerie to target additional territories including Europe, China and several other regions. 

An estimated 76 million people worldwide live with glaucoma.5 It is the second most common cause of blindness worldwide6,7 and affects the optic nerve connecting the eye to the brain. It is estimated that approximately 7.85 million people will suffer from glaucoma in Europe in 2040.5 

As a specialised company dedicated to ophthalmology with a global footprint in over 60 countries, Santen is committed to reducing the loss of social and economic opportunities due to eye conditions to bring “Happiness with Vision” to everyone in the world.

References:

  1. European Medicines Agency (EMA). Rhokiinsa summary of product characteristics
  2. European Medicines Agency (EMA). Roclanda summary of product characteristics
  3. Ren R, Li G et al. Invest Ophthalmol Vis Sci. 2016;1;57(14):6197-6209
  4. Asrani S, Bacharach J et al. Adv Ther. 2020;37:1620-1631
  5. Tham Y-C et al. Ophthalmology. 2014;121(11):2081-2090
  6. Pascolini D et al. Br J Ophthalmol. 2012;96:614-618
  7. Quigley HA et al. Br J Ophthalmol. 2006;90:262-267

About Santen
As a global specialised company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen’s long-term vision is to become a social innovator in ophthalmology and address social and economic issues related to eye health by strategically exploring advancing technologies and collaborating with key leaders around the world. Underpinned by its people-centric values, Santen aims to ultimately deliver happiness with vision – a life with the best vision experience for every individual around the world. With scientific knowledge and organisational capabilities nurtured over 130 years, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s websites www.santen.eu (Europe, Middle East and Africa, EMEA) and www.santen.com (Japan headquarters).

Document number: NP-GLAU-EMEA-0263
Date of preparation: February 2022