Amber - XEN Gel Implant - new innovation in glaucoma management arrives in NZ

The first and only injectable glaucoma gel implant in New Zealand®- XEN® Gel Implant1 - for people with primary open-angle glaucoma, whose condition is not well managed with glaucoma drops, is now available in New Zealand.2

Studies show XEN® is effective and efficient at achieving sustained low-teen intraocular pressure (IOP) lowering,3,4 with over half of patients drop-free at 12 months.3

XEN® is based on the same principle as a trabeculectomy, creating a new outflow channel bypassing trabecular and scleral resistance forming a diffuse, low-lying bleb.5 Inserted using XEN® injector via an ab-interno approach, the 6mm permanent soft gel implant 5 is a biocompatible, tissue conforming implant that becomes soft and flexible when hydrated,5,6 creating a new subconjunctival outflow pathway from the anterior chamber to the subconjunctival space.2,5 XEN® has been developed with a 45μm tube which provides around 6–8mmHg flow resistance, which reduces risk of hypotony.5 It is designed as a stand-alone procedure but can be combined with cataract surgery.2,3

Results from a 12 month interim analysis of an ongoing clinical trial (APEX) found that 70 per cent of people with XEN® achieved equal to or less than 15mm Hg IOP, with the mean IOP at 13.8mmHg, from a treated baseline of 21.4mmHg.3 Furthermore, 56 per cent of patients were ‘drop-free’ at 12 months and mean IOP lowering medications were reduced from 2.6 to 0.6 at 12 months (p<0.0001).3 There was no symptomatic hypotony or major complications.3

Professor Ingeborg Stalmans, Head of the Glaucoma Unit, Director of the Ophthalmology Research Group, University of Leuven, Belgium said that as glaucoma is the leading cause of irreversible blindness, newer technologies provide much needed options for ophthalmologists.

“Technologies that allow ophthalmologists to deliver strong patient results in a more time efficient manner are becoming increasingly important in countries that are struggling to meet the demands of large numbers of people with glaucoma,” she added.

At the end of 2016, there were more than 20,000 people in New Zealand who were overdue for a follow-up ophthalmology appointment.7 Approximately three XEN® procedures can be done in the time required for one trabeculectomy.8,9 It also has a less intensive and time-consuming follow up than trabeculectomy,8,10 and importantly for patients a reduced risk of post-operative complications versus trabeculectomy.8,10

Professor Helen Danesh-Meyer, surgeon at The Eye Institute and Chair of Glaucoma New Zealand said strategies that free up ophthalmologists to treat more patients and make life simpler for glaucoma patients are of real interest.

Glaucoma affects 10% of New Zealanders over the age of 70,11 with primary open angle glaucoma being the most common form.12,13 Approximately 560 glaucoma surgeries are conducted per year12,14 of which 62% are trabeculectomies and 21% are aqueous shunts.12

“We need to see more surgical options which are both better tolerated and more efficient. This may have the dual benefit of decreasing the morbidity and recovery time following surgery as well as

increasingavailabilityof clinic timesothat more patientscanbe seenin an appropriate timeframe tominimise the risk of life-changing consequences dueto delayed treatment.It is a goal of ophthalmologists tosimplify the patient’streatmentregimen,”added Prof. Danesh-Meyer.

Onlya small percentageof XEN®patients experiencedhypotony-related adverseevents, including1.3% choroidal effusion (self limited,lasting<30 days)and 0.4% anterior chamber refill.^2,3,15

TheXEN Gel Implant is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. Always refer to full instructions before use. Adverse events should be reported to the local Allergan office 0800659 912.

Patients may need to pay for The Xen Glaucoma Gel Implant treatment. They should discuss this with their Ophthalmic surgeon.