Santen Corporate (EN)

Santen Obtains Manufacturing and Marketing Approval in Japan for Rhopressa® Ophthalmic Solution 0.02%, a Treatment for Glaucoma and Ocular Hypertension

June 19, 2026 - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has obtained manufacturing and marketing approval in Japan for Rhopressa® Ophthalmic Solution 0.02% (generic name: netarsudil mesylate; development code: STN1013900; hereinafter the product), a treatment for glaucoma and ocular hypertension.

The product is an ophthalmic solution containing netarsudil mesylate as its active ingredient. It is believed to lower intraocular pressure by inhibiting Rho kinase (ROCK), thereby promoting aqueous humor outflow through the trabecular outflow pathway, and by inhibiting the norepinephrine transporter, resulting in reduced aqueous humor production. Furthermore, the active metabolite AR-13503 has been shown to have ROCK inhibitory activity, adding to its pharmacological effects. These combined mechanisms result in meaningful intraocular pressure reduction.

In the current pharmacological treatment of glaucoma, ophthalmic solutions such as prostanoid receptor analogues and β‑adrenergic blockers are widely used. When sufficient intraocular pressure reduction cannot be achieved with existing ophthalmic solutions, switching or combination treatment with drugs having different mechanisms of action is generally employed.1 However, this often requires an increased number of daily instillations, which may negatively impact patient adherence. Therefore, there remains a need for monotherapy treatment options that require fewer daily instillations and provide potent intraocular pressure–lowering effects. The product is a once‑daily ophthalmic solution indicated for the treatment of glaucoma and ocular hypertension in patients who show an insufficient response to, or are unable to use, existing glaucoma therapies due to adverse effects, and is expected to provide treatment options for these patients.

The efficacy and safety of the product were assessed in Phase III studies conducted in Japan, including a comparative study with ripasudil (J-ROCKET-1), a combination study with latanoprost (J-ROCKET-2), and a long-term administration study (J-ROCKET-3), which led to its approval.

Santen’s Chief Medical Officer Peter Sallstig commented: “In the treatment of glaucoma, monotherapy may not always achieve sufficient efficacy, necessitating a switch to or concomitant treatment with different mechanisms of action, including combination therapy. In clinical trials, once‑daily administration of the product demonstrated intraocular pressure–lowering effects both as monotherapy and in combination with other therapies. We believe it has the potential to address unmet needs in existing treatments and to contribute as a new therapeutic option in glaucoma management.”

As a specialized company dedicated to ophthalmology, Santen seeks to contribute to the improved quality of life of glaucoma patients in Japan by providing more treatment options in clinical settings.

This drug is currently sold under the name Rhokiinsa® in the UK and Sweden, and under the name Rhopressa® in South Korea*.

* Regions where Santen operates (excluding the Americas) Rhokiinsa® and Rhopressa® are registered trademarks of Alcon Inc.

About Glaucoma
Glaucoma is a disease in which the optic nerve is damaged by increased intraocular pressure or other factors, causing progressive visual field loss. Without appropriate treatment, the condition can lead to blindness. Because glaucoma-related optic nerve damage and visual field loss are fundamentally progressive and irreversible, early diagnosis and treatment is critically important, and lowering intraocular pressure is an effective therapeutic approach to slow the progression of glaucoma. Glaucoma is a major cause of irreversible blindness worldwide. In 2013, an estimated 64.3 million people lived with glaucoma. That number is expected to reach 111.8 million in 2040.2  Among Japanese people aged 40 and over, it has been reported that 5.0% have glaucoma (primary open-angle glaucoma 3.9%, primary angle-closure glaucoma 0.6%, secondary glaucoma 0.5%) and 0.8% have ocular hypertension,3, 4 and it remains the leading cause of visual impairment (vision loss and blindness) in Japan.5 The percentage of people living with glaucoma increases with age and as the average age of the Japanese population is rising, the proportion of people in Japan with the condition is also expected to increase, making early diagnosis and treatment ever more important.

References

  1. Glaucoma Treatment Guidelines (5th edition). Jpn J Ophthalmol. 2022;126:85-177.
  2. Tham YC, et al. Ophthalmology. 2014;121:2081-90.
  3. Iwase A, et al; Ophthalmology. 2004;111:1641-8.
  4. Yamamoto T, et al; Ophthalmology. 2005;112:1661-9.
  5. Matoba R, et al. Jpn J Ophthalmol. 2023;67(3):346–352.

About Santen
Santen is a global pharmaceutical company committed to advancing eye health and improving lives through better vision. Founded in 1890 in Osaka, Japan, Santen makes use of more than 135 years of experience in research and development, manufacturing, and marketing of pharmaceuticals and medical devices to help people around the globe maintain and improve their eye health. Santen focuses exclusively on eye health and its portfolio includes glaucoma, dry eye, infection, allergy, age-related macular degeneration, and myopia. Santen’s products and services are available in more than 60 countries and regions. Guided by its Core Principle “Tenki ni sanyo suru” – Exploring the secrets and mechanisms of nature in order to contribute to people’s health – Santen combines its expertise with deep patient focus to contribute to the realization of “Happiness with Vision.”
For more information, please visit https://www.santen.com/en.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com