- The XEN 63 Gel Implant is intended to reduce intraocular
pressure (IOP) in patients with primary open angle
glaucoma1
- XEN 63 is a minimally invasive, micro-incisional glaucoma
surgery designed to lower IOP2
- XEN 63 Gel Implant provides innovative treatment option for
Canadians impacted by glaucoma
MONTREAL, Sept. 27,
2022 /CNW/ - AbbVie (NYSE: ABBV) announced today
the availability of the XEN® 63 Gel Implant, a surgical
implant designed to lower high eye pressure in open angle glaucoma
sufferers, where previous medical treatment options have
failed.1 The XEN 63 Gel Implant is an additional
option for surgeons, clinically proven to reduce intraocular
pressure (IOP) in patients with primary open angle
glaucoma.3
![AbbVie Logo (CNW Group/AbbVie Canada) AbbVie Logo (CNW Group/AbbVie Canada)](https://mma.prnewswire.com/media/1908101/AbbVie_Canada_XEN__63_Gel_Implant_available_now_for_patients_wit.jpg)
"I see the impact of glaucoma on patients' quality of life every
day in my practice. Glaucoma typically damages the peripheral
vision first, so it often goes unnoticed by patients as the disease
worsens. That's why glaucoma is known as the silent thief of
sight," said Dr. David Yan,
Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto and Glaucoma Service
Director, Kensington Eye Institute. "XEN 63 Gel Implant offers
patients a new surgical option to reduce intraocular pressure when
medical therapy cannot adequately control the disease and
renewed hope to prevent optic nerve damage."
XEN 63 is a gel implant consisting of a small 6mm long tube,
delivered via a micro-incisional glaucoma
surgery.1,2 It creates a new
fluid outflow channel using a similar principle to conventional
trabeculectomy, but allows fluid to bypass the impaired trabecular
meshwork, the drainage system that becomes impaired in
glaucoma.2,4
"Glaucoma affects more than 728,000 Canadians. It is one of the
leading causes of preventable blindness. Anyone can develop
glaucoma but there are several different factors that can increase
your risk of developing the disease," said Doug Earle, President and CEO of Fighting
Blindness Canada. "It's both exciting and important to see new,
innovative treatment options being approved that could have a
positive impact on Canadians living with primary open angle
glaucoma."
"As a leader in Eye Care in Canada, we are committed to help preserve and
protect people's vision through innovating and addressing the
greatest unmet needs in glaucoma," says Tracey Ramsay, Vice President and General
Manager, AbbVie Canada. "Today, we're pleased to launch the XEN 63
Gel Implant and offer a minimally invasive solution for
uncontrolled primary open angle glaucoma."
The glaucoma treatment spectrum extends from pharmacotherapy
involving topical medications (eye drops) as the first-line therapy
to traditional, invasive filtration surgeries, such as
trabeculectomy and aqueous shunt implantation.5,6,7
Common challenges associated with pharmacotherapy include
ineffective use (e.g., incorrect dose timing or
administration),8,9 local or systemic side
effects (e.g., irritation) or toxicity,10,11 and
considerable lifetime costs.12 Filtration surgical
options are typically used in advanced glaucoma cases or when
targeting a very low intraocular pressure as a treatment
outcome.13 These invasive surgeries may be considered
for medically refractory cases, or when there are such issues as
intolerable side effects or from ineffective use of
medications.14
About Glaucoma
Glaucoma affects more than 728,000 Canadians and takes the form
of several related disease types, the most common being open angle
glaucoma.15 Glaucoma is characterized by a build-up of
aqueous humour fluid and increased intraocular pressure (IOP) that
damages the optic nerve.15 There is no cure for
glaucoma, but early detection and treatment can help prevent damage
to the optic nerve, and as a result, save
vision.15
About XEN 63
XEN is a gel implant consisting of a small 6mm long tube,
delivered via a micro-incisional glaucoma surgery, which is
intended to reduce intraocular pressure in patients with primary
open angle glaucoma where previous medical treatments have
failed.1 The XEN filtration procedure creates a new
fluid outflow channel using a similar principle to trabeculectomy,
but allows fluid to bypass the impaired trabecular
meshwork.2,3 XEN is inserted via an ab-interno
approach1 (from within the anterior chamber) and allows
aqueous humor to flow out from the anterior chamber into the
subconjunctival space, minimizing tissue disruption seen with
trabeculectomy or traditional glaucoma drainage implants.1,3,
16 XEN 63 consists of a small tube that is 6mm
long.1 The inner diameter of XEN63 is 63µm and the
external diameter is 170µm.1 XEN63 has an outflow
resistance of 2-3mmHg.6 XEN63 was developed to increase
the aqueous humor flow rate with the intention of potentially
providing lower IOPs.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter
and Instagram, or find us on LinkedIn.
1
|
AbbVie Canada. Add XEN
63 Gel Implant Health Canada directions for use.
|
2
|
European Glaucoma
Society Terminology and Guidelines for Glaucoma, 5th Edition.
(2021). British Journal of Ophthalmology, 105(Suppl 1),
pp.1–169. doi:10.1136/bjophthalmol-2021-egsguidelines
|
3
|
Lavin-Dapena C,
Cordero-Ros R, D'Anna O, Mogollón I. XEN 63 gel stent device in
glaucoma surgery: A 5-years follow-up prospective study. Eur J
Ophthalmol. 2021 Jul;31(4):1829-1835. doi:
10.1177/1120672120952033. Epub 2020 Aug 18. PMID: 32811168.
https://pubmed.ncbi.nlm.nih.gov/32811168/
|
4
|
De Gregorio A, et al.
Clin Ophthalmol. 2018;12:773-782.
doi:10.2147/OPTH.S146919.
|
5
|
Samuelson TW, Katz LJ,
Wells JM, Duh YJ, Giamporcaro JE, US iStent Study Group. Randomized
evaluation of the trabecular micro-bypass stent with
phacoemulsification in patients with glaucoma and cataract.
Ophthalmology. 2011 Mar;118(3):459-67.
|
6
|
Malvankar-Mehta MS,
Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, et al. iStent
with phacoemulsification versus phacoemulsification alone for
patients with glaucoma and cataract: A meta-analysis. PLoS One
[Internet]. 2015 [cited 2018 Jan 2];10(7):e0131770. Available
from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4492499/
|
7
|
Saheb H, Ahmed II.
Micro-invasive glaucoma surgery: current perspectives and future
directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104.
|
8
|
Okeke CO, Quigley HA,
Jampel HD, Ying GS, Plyler RJ, Jiang Y, et al. Adherence with
topical glaucoma medication monitored electronically the Travatan
Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9.
|
9
|
Terminology and
guidelines for glaucoma [Internet]. 4th ed. Savona (ITA): European
Glaucoma Society; 2014 Jun. [cited 2017 Aug 8].
Available: http://www.icoph.org/dynamic/attachments/resources/egs_guidelines_4_english.pdf
|
10
|
Everitt DE, Avorn J.
Systemic effects of medications used to treat glaucoma. Ann Intern
Med. 1990 Jan 15;112(2):120-5.
|
11
|
Sambhara D, Aref AA.
Glaucoma management: relative value and place in therapy of
available drug treatments. Ther Adv Chronic Dis [Internet]. 2014
Jan [cited 2017 Dec 22];5(1):30-43.
Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871276
|
12
|
Iordanous Y, Kent JS,
Hutnik CM, Malvankar-Mehta MS. Projected cost comparison of
Trabectome, iStent, and endoscopic cyclophotocoagulation versus
glaucoma medication in the Ontario Health Insurance Plan. J
Glaucoma. 2014 Feb;23(2):e112-e118.
|
13
|
Perez-Torregrosa VT,
Olate-Perez A, Cerda-Ibanez M, Gargallo-Benedicto A, Osorio-Alayo
V, Barreiro-Rego A, et al. Combined phacoemulsification and XEN45
surgery from a temporal approach and 2 incisions. Arch Soc Esp
Oftalmol. 2016 Sep;91(9):415-21.
|
14
|
Michael Raj, Charlotte
Wells, Caitlyn Ford. Minimally Invasive Glaucoma Surgery:
Implementation Considerations. Ottawa: CADTH; 2018. (Environmental
scan; no. 76).
https://www.cadth.ca/minimally-invasive-glaucoma-surgery-implementation-considerations-0
|
15
|
Fighting Blindness.
Glaucoma. Available at:
https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/
|
16
|
Lewis RA. J Cataract
Refract Surg. 2014;40(8):1301–6. doi:
10.1016/j.jcrs.2014.01.032.
|
SOURCE AbbVie Canada