AbbVie receives Japanese approval for XEN45 glaucoma treatment system

AbbVie has received manufacturing and sales approval in Japan for the XEN45 Glaucoma Treatment System, an intraocular drain designed to manage refractory glaucoma. The approval, effective October 9, 2026, follows positive results from the P13-001 multi-center clinical trial.

The system consists of a 6.0mm gelatin-based tubular implant. It is placed between the anterior chamber and the subconjunctival space to create a new outflow pathway for aqueous humor, thereby reducing intraocular pressure.

Glaucoma is the leading cause of blindness in Japan, affecting approximately 5% of the population aged 40 and older. The XEN45 device offers a minimally invasive surgical option for patients who do not achieve sufficient pressure reduction through conventional drug or laser therapies, potentially reducing the burden associated with more invasive procedures like trabeculectomy.