AqueSys

XEN

The current approach in the management of patients with glaucoma begins with medications followed by laser trabeculoplasty, and then either a trabeculectomy or a glaucoma drainage device. Both are highly effective, yet invasive and complication-prone solutions.

Traditional trabeculectomy and tube shunt procedures require substantial dissection of the ocular tissues, and have a relatively high complication rate (up to 50% at one year). Unfortunately, these procedures are not only invasive, but also have a high degree of variability that can lead to too little or too much intraocular pressure reduction (IOP). Despite these high complication rates and variability, these procedures are still the most common glaucoma surgeries performed globally due to the need for significant efficacy.

Worldwide, doctors accept that the subconjunctival outflow pathway delivers the greatest IOP reduction because it has been proven in millions of cases during 50+ years of usage. AqueSys has developed a new technology that is designed to have similar efficacy as the invasive gold standard procedures yet through a standardized minimally invasive procedure that has the potential to significantly lower traditional complication rates.

XEN

A minimally invasive approach to the gold standard mechanism of action for the treatment of glaucoma

The XEN Gel Stent is made of a permanent, soft, collagen-derived, gelatin. Upon implantation, it creates a gentle, diffuse outflow of aqueous from the anterior chamber into the non-dissected tissue of the subconjunctival space. The AqueSys gelatin is well accepted by the human body, and is non-inflammatory. The pliability and softness allows it to conform to the ocular tissue, which may be shown to minimize many of the issues seen with synthetic materials (e.g., migration, erosion, corneal endothelial damage).

6mm XEN implant

The 6mm XEN implant positioned next to an Ahmed Glaucoma Valve (New World Medical, Inc.)

Anterior segment OCT

Anterior segment OCT image shows the soft XEN implant conforming to tissue in a human eye

The XEN Gel Stent is 6mm long and about the width of a human hair. It is injected through a small self-sealing corneal incision using a simple, preloaded IOL-like injector.

XEN Injector
XEN Injector

XEN Injector, showing implant, needle and sleeve

Potential benefits of the XEN Gel Stent include:

  • Significant and sustained reduction of IOP through the globally accepted and well-studied subconjunctival outflow pathway
  • Minimally invasive subconjunctival approach bypasses all potential aqueous outflow obstructions
  • Soft gelatin material minimizes complications related to synthetic materials
  • Significant ocular tissue available after the procedure, leaving all other treatment options available for the patient’s future care

The AqueSys XEN Gel Stent has CE mark internationally, and is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed.

In the United States, the XEN Gel Stent is an investigational device, which means that it has not been approved by the US Food and Drug Administration (FDA). The company is currently enrolling subjects under an approved IDE for its first indication in the United States.