The FINANCIAL — Allergan plc on October 19 announced that it has successfully completed the acquisition of AqueSys, Inc. a clinical-stage medical device company focused on developing ocular implants that reduce intraocular pressure (IOP) associated with glaucoma.
Allergan acquired AqueSys in an all-cash transaction, including a $300 million up-front payment and potential regulatory approval and commercialization milestone payments related to AqueSys’ lead development product, XEN45.
The AqueSys acquisition adds XEN45, a soft shunt used in minimally invasive glaucoma surgeries (MIGs). XEN45 is implanted by ophthalmologists in the anterior chamber of the eye through a minimally invasive procedure with a single-use, pre-loaded injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower IOP while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures, according to Allergan.
“The acquisition of AqueSys and XEN45 is highly complementary to our leadership position in eye care and underscores our commitment to develop and commercialize treatments that advance care and add value for ophthalmologists and their patients,” said Brent Saunders, CEO and President of Allergan. “The treatment of glaucoma is increasingly shifting to dropless therapies given the challenges of patient compliance. The XEN45 device provides a minimally invasive approach to lowering IOP for physicians and their patients seeking new ways to treat glaucoma that go beyond conventional eye drop treatments.”
XEN45 has received a CE mark in the European Union where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. The CE mark allows treatment in conjunction with a cataract procedure or as a standalone procedure. XEN45 is also approved for use in Turkey, Canada and Switzerland. In the United States, XEN45 is in late-stage development, with the final U.S. Investigational Device Exemption (IDE) clinical trial fully enrolled as of the second quarter of 2015. Final approval by the U.S. Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway.
“In my glaucoma patients, I see a tremendous need for products that can help improve the process and compliance of treatment, in a minimally invasive way,” said Ike Ahmed, MD, University of Toronto. “XEN45 provides just that – a minimally invasive procedure that helps to lower IOP effectively while minimizing the need for patients to remember, and be compliant with, their treatment. It’s an important innovation for the glaucoma treatment community. ”
XEN45 adds to Allergan’s strong late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration (AMD) and diabetic macular edema (DME).