Santen to Launch UPNEEQ^® Mini Ophthalmic Solution 0.1%, a Treatment for Acquired Blepharoptosis

April 1, 2026 – Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that it will launch UPNEEQ^® Mini Ophthalmic Solution 0.1% (generic name: oxymetazoline hydrochloride; hereinafter the product), for acquired blepharoptosis, in Japan on May 15, 2026. The product is scheduled to be sold as a drug not listed in the National Health Insurance Drug Price Standard and will not be covered by public medical insurance.

Oxymetazoline, the active ingredient of the product, has been reported to act as an agonist of α₁- and α₂-adrenergic receptors¹. By acting on α receptors in Müller’s muscle, which contributes to eyelid elevation, the product induces muscle contraction and lifts the upper eyelid². In a Phase 3, placebo-controlled, randomized, double-masked study conducted in Japan, the efficacy and safety of once-daily administration of the product were evaluated in patients with acquired blepharoptosis. The superiority of once-daily administration of the product over placebo eye drops was demonstrated in the primary endpoint of a change from baseline at 2 hours after administration in MRD-1 (Marginal Reflex Distance-1, the margin between the upper eyelid and the center of the pupil) * at Day 14 after the start of treatment. Based on these results, Santen applied for manufacturing and marketing approval in December 2024 and obtained approval in December 2025 for acquired blepharoptosis.

Ippei Kurihara, Head of Japan Business and Business Development at Santen, commented: “Blepharoptosis not only causes changes in appearance due to drooping of the upper eyelid, but may also lead to narrowing of the visual field and result in a variety of difficulties, including eye strain, headaches, and shoulder stiffness, as the condition progresses. In Japan, surgery is currently the only approved medical treatment option for blepharoptosis. Through the launch of this non‑invasive treatment, Santen aims to deliver a new medical treatment option to patients with acquired blepharoptosis.”

With this product – the first approved pharmacological treatment for acquired blepharoptosis in Japan –Santen will continue to address the needs of patients with acquired blepharoptosis in Japan while striving to provide new treatment options to patients with blepharoptosis worldwide.

* In this clinical study, MRD-1 was defined as the distance from the center of the pupil to the upper eyelid margin, as determined from anterior segment photographs.

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About Blepharoptosis
Blepharoptosis is classified into congenital and acquired forms, and acquired blepharoptosis has various causes. In many cases, the condition is caused by age-related changes in the tendon that lifts the eyelid, with long-term contact lens wear reported as a risk factor^3–6. Drooping of the upper eyelid leads to noticeable changes in appearance and may cause a variety of symptoms, including loss of the superior visual field, stiff shoulders, headaches, and fatigue⁷. Current treatment options for blepharoptosis in Japan are limited to surgical procedures.

About UPNEEQ^® Mini Ophthalmic Solution 0.1%
In July 2020, Santen entered into an exclusive license agreement with Osmotica Pharmaceuticals plc (due to a company name change, now known as RVL Pharmaceuticals, Inc), covering the continued development, registration, and commercialization rights for RVL-1201, a 0.1% oxymetazoline hydrochloride ophthalmic solution, in Japan, China, other Asian countries, and EMEA (Europe, Middle East and Africa). Santen has been developing the product as STN1013800.
In the United States, RVL Pharmaceuticals, Inc has obtained approval from the U.S. Food and Drug Administration (FDA) for UPNEEQ^® (oxymetazoline hydrochloride ophthalmic solution 0.1%) for the treatment of acquired blepharoptosis in adults, and the product is marketed as the first and only FDA-approved treatment for acquired blepharoptosis in adults in the United States.

References

1. Haenisch B, et al. Fundam Clinical Pharmacol. 2010;24(6):729–39.
2. Slonim CB, et al. JAMA Ophthalmol. 2020;138(11):1168–1175.
3. Custer PL, et al. Ophthalmology. 3rd ed. 2008:1397–1403.
4. Van den Bosch WA, et al. Ophthalmology. 1992;99(12):1759–1765.
5. Kersten RC, et al. Ophthalmology. 1995;102(6):924–928.
6. Reddy AK, et al. Ophthalmology. 2007;114(12):2370.
7. Battu VK, et al. American J Ophthalmol. 1996;121(6):677–686.

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