XEN® 63 Gel Implant available now for patients with primary open angle glaucoma where previous medical treatments have failed

  • 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)

"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

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