#Japan #AbbVie #glaucoma #Minato #XEN45

AbbVie Gains Ground in Glaucoma Treatment with XEN45 Approval in Japan

AbbVie, a global biopharmaceutical company headquartered in Minato, Tokyo, has announced that it obtained manufacturing and sales approval for the XEN45 glaucoma treatment system as of October 9, 2026. This innovative medical device offers a new option for glaucoma patients who do not achieve sufficient intraocular pressure reduction through standard drug or laser treatments.

Glaucoma is a progressive disease characterized by damage to the optic nerve, which can lead to narrowing of the field of vision and ultimately result in vision loss. In Japan, glaucoma is the leading cause of blindness, affecting approximately 5.0% of individuals over the age of 40. While early detection and appropriate therapy can enable patients to maintain their vision, the challenges in managing this condition remain significant.

Understanding Glaucoma and Its Treatment Options

The treatment methods for glaucoma primarily include medication, laser therapy, and surgical interventions, all aimed at lowering intraocular pressure. For many patients, traditional treatments may not suffice in controlling pressure levels. Surgical options, such as trabeculectomy, have been used but come with higher invasiveness and post-operative management challenges that can burden both patients and healthcare providers.

The XEN45 system introduces a low-invasive surgical device designed to create a new drainage pathway for aqueous humor from the anterior chamber to the subconjunctival space, effectively lowering intraocular pressure. The device features a gelatin-based, thin tube implant measuring 6.0 mm in length, which simplifies the surgical procedure compared to traditional methods.

A Message from AbbVie's President

Tiago Campos Rodrigues, President of AbbVie, expressed his enthusiasm about the approval of XEN45 in Japan, emphasizing the ongoing need for new treatment options for the millions affected by glaucoma. He stated, "We are thrilled to have received manufacturing approval for XEN45. Glaucoma is the leading cause of blindness in Japan, and many patients require ongoing treatment throughout their lives. We hope that XEN45 will serve as a beneficial alternative for those who struggle to manage their intraocular pressure with conventional methods. AbbVie remains dedicated to enhancing patient quality of life through innovative treatment solutions and advancing eye care in Japan."

Clinical Trials Leading to Approval

The approval of XEN45 is based largely on results from a multi-center clinical trial (P13-001) focusing on patients with refractory glaucoma. This critical research supports the device's efficacy and safety in promoting intraocular pressure reduction.

Features of the XEN45 Device

The XEN45 implant functions by being placed between the anterior chamber and the subconjunctival area, effectively creating a new route for aqueous humor drainage. Currently, it is approved in various regions including the U.S., Europe, and parts of Asia.

The Broader Picture on Glaucoma

As a chronic eye condition, glaucoma can severely impact vision and quality of life, creating long-term medical and economic burdens for affected individuals. Diagnosis often occurs without noticeable symptoms, meaning many could suffer irreversible damage before seeking treatment. Timely detection and appropriate management are crucial in preserving vision and preventing the condition's progression. Therefore, solutions like XEN45 are vital in addressing the needs of patients who require alternative treatment pathways.

About AbbVie

AbbVie is committed to creating innovative products and solutions to address significant health challenges. The company focuses on various therapeutic areas, including immunology, neurosciences, oncology, and aesthetic medicine through the Allergan Aesthetics portfolio. In Japan, AbbVie is actively involved in developing and providing treatments for immune disorders, liver diseases, mental health issues, cancers, and eye care. More information about AbbVie can be found at www.abbvie.com and www.abbvie.co.jp.