Allergan Completes Acquisition of AqueSysBy
Allergan 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, a soft shunt used in minimally invasive glaucoma surgeries.
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.
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 US Investigational Device Exemption (IDE) clinical trial fully enrolled as of the second quarter of 2015. Final approval by the US Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway.
XEN45 adds to Allergan’s late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration, and diabetic macular edema.