Biotech

ABBVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH. 1 In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p

"We remain steadfast in our pursuit of transforming the treatment landscape for people living with ulcerative colitis," said Tom Hudson , senior vice president of research and development, AbbVie. "These positive results confirm the findings of the previous induction study and underscore the potential impact upadacitinib could have on patients struggling to manage their disease."

In this study, all ranked secondary endpoints were met, including clinical, endoscopic and histologic outcomes. 1 A greater proportion of patients treated with upadacitinib achieved clinical response compared to placebo, with 74 percent of upadacitinib-treated patients experiencing clinical response (per Adapted Mayo Score) at week 8 versus 25 percent of patients receiving placebo (p 1 Additionally, 63 percent of patients treated with upadacitinib achieved clinical response (per partial Adapted Mayo Score) at week 2 versus 26 percent of those receiving placebo (p 1 At week 8, 44 percent of patients treated with upadacitinib achieved endoscopic improvement versus 8 percent of patients receiving placebo (p 1 And significantly more upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week 8 compared to patients receiving placebo (37 percent versus 6 percent; p 1

"People living with moderate to severe ulcerative colitis continue to suffer from the significant burden of this disease," said Silvio Danese , M.D., lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy . "I am very impressed with the consistent results seen in both ulcerative colitis induction studies, suggesting that upadacitinib could be a potential new treatment option for patients."

U-ACCOMPLISH Efficacy Results at Week 8 *,1


Upadacitinib 45 mg, once daily

(n=341)

Placebo

(n=174)

Clinical remission (per Adapted Mayo Score) a,†

33%

4%

Clinical response (per Adapted Mayo Score) b,†

74%

25%

Endoscopic improvement c,†

44%

8%

Histologic-endoscopic mucosal improvement d,†

37%

6%

*Primary endpoint was clinical remission (per Adapted Mayo Score). Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were ranked secondary endpoints. Not all ranked secondary endpoints are shown. All primary and ranked secondary endpoints achieved p-values of

a Clinical remission (per Adapted Mayo Score) is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1.

b Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Adapted Mayo score ≥2 points and ≥30 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1.

c Endoscopic improvement is defined as endoscopic subscore ≤1.

d Histologic-endoscopic mucosal improvement is defined as endoscopic subscore of 0 or 1 and Geboes score ≤3.1.

Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopy activity will confer an endoscopic subscore of 2.

The safety profile of upadacitinib (45 mg) was consistent with the safety findings in the previously reported Phase 3 induction study in ulcerative colitis and safety findings in previous studies across indications, with no new safety risks observed. 1-6 During the 8-week study period, the most common adverse events observed in the upadacitinib group were acne, blood creatine phosphokinase increase and anemia. 1 The increases in blood creatine phosphokinase were non-serious and did not lead to study drug discontinuation. 1 Patients with blood creatine phosphokinase increase were usually asymptomatic and no cases of rhabdomyolysis were reported. 1 Serious adverse events occurred in 3.2 percent of patients in the upadacitinib group and 4.5 percent of patients in the placebo group. 1 Similar rates of serious infections (0.6 percent) were observed in the two treatment groups. 1 No deaths, gastrointestinal perforation, malignancy, major cardiovascular or thromboembolic events were reported in the upadacitinib group. 1 One case of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and one case of gastrointestinal perforation was reported in the placebo group. 1

Full results from the U-ACCOMPLISH study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Top-line results from the Phase 3 portion of the first induction study, U-ACHIEVE, were announced in December 2020 and the maintenance study for both is ongoing. Use of upadacitinib in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Ulcerative Colitis

Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine, which triggers abdominal pain, bloody diarrhea, severe urgency for a bowel movement, weight loss and fatigue. 15-17 The severity of symptoms and uncertainty surrounding flares cause a substantial burden and often disability among those living with the disease. 18

About the U-ACCOMPLISH Study 1,9

U-ACCOMPLISH is a Phase 3 multicenter, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib 45 mg once daily for induction therapy compared to placebo in subjects with moderate to severe ulcerative colitis. U-ACCOMPLISH is the second of two Phase 3 induction studies.

The primary endpoint is achievement of clinical remission (per Adapted Mayo Score) at week 8. Ranked secondary endpoints included clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1) and histologic-endoscopic mucosal improvement (endoscopic subscore of 0 or 1 and Geboes score ≤3.1) at week 8. More information can be found on www.clinicaltrials.gov (NCT03653026).

About the Upadacitinib Ulcerative Colitis Program 9,19,20

The global upadacitinib ulcerative colitis program evaluates more than 1,300 patients with moderately to severely active ulcerative colitis across three pivotal studies. These studies include assessments of efficacy and safety of upadacitinib. Key measures of efficacy include clinical remission (per Adapted Mayo Score), clinical response (per Adapted Mayo Score), endoscopic improvement and endoscopic response. More information on these trials can be found at www.clinicaltrials.gov (NCT03653026, NCT02819635, NCT03006068).

About Upadacitinib (RINVOQ)

Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. 1,7-14 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2. 3 In August 2019 , RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing. 8-14 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

Important Safety Information about RINVOQ (upadacitinib) 21

RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

  • Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
  • Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
  • Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
  • Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

  • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
    • Fever, sweating, or chills
    • Shortness of breath
    • Warm, red, or painful skin or sores on your body
    • Muscle aches
    • Feeling tired
    • Blood in phlegm
    • Diarrhea or stomach pain
    • Cough
    • o Weight loss
    • Burning when urinating or urinating more often than normal
  • Have TB or have been in close contact with someone with TB.
  • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  • Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  • Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.
  • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
  • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
  • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

  • Medicines for fungal or bacterial infections
  • Rifampicin or phenytoin
  • Medicines that affect your immune system

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?
Tell your HCP right away if you:

  • Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
  • Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
    • Swelling
    • Sudden unexplained chest pain
    • Pain or tenderness in the leg
    • Shortness of breath
  • Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .

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.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

  1. AbbVie. Data on File: ABVRRTI71710.
  2. AbbVie. Data on File: ABVRRTI71469.
  3. Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.
  4. Mease P.J., et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020 Dec 3 ;annrheumdis-2020-218870. doi: 10.1136/annrheumdis-2020-218870.
  5. Van der Heijde D ., et al. Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients With Active Ankylosing Spondylitis. 2019 ACR/ARP Annual Meeting; 2728.
  6. Guttman-Yassky, E., et al. Safety and Efficacy of Upadacitinib Monotherapy in Adolescents and Adults with Moderate-to-severe Atopic Dermatitis: Results From 2 Pivotal, Phase 3, Randomized, Double-blinded, Monotherapy, Placebo-controlled Studies (Measure Up 1 and Measure Up 2). European Academy of Dermatology and Venerology Congress. 2020. D3T03.4B.
  7. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on February 12, 2021 .
  8. Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512.
  9. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026 . Accessed on February 12, 2021 .
  10. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649 . Accessed on Accessed on February 12, 2021 .
  11. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400 . Accessed on February 12, 2021 .
  12. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed on February 12, 2021 .
  13. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397 . Accessed on February 12, 2021 .
  14. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed on February 12, 2021 .
  15. The Economic Costs of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf . Accessed on February 12, 2021 .
  16. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf . Accessed on February 12, 2021 .
  17. Ulcerative colitis. Symptoms and Causes. Mayo Clinic. 2020. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326 . Accessed on February 12, 2021 .
  18. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
  19. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on Accessed on February 12, 2021 .
  20. A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03006068 . Accessed on February 12, 2021 .
  21. RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.

Cision View original content: http://www.prnewswire.com/news-releases/second-phase-3-induction-study-confirms-upadacitinib-rinvoq-improved-clinical-endoscopic-and-histologic-outcomes-in-ulcerative-colitis-patients-301231986.html

SOURCE AbbVie

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The Gummy Project Continues Strategic Expansion in US Hotel Sector After Receiving Purchase Order from Virgin Hotels Chicago to Become Supplier of Gummy Products for Guest Room Mini-Bars

The Gummy Project Continues Strategic Expansion in US Hotel Sector After Receiving Purchase Order from Virgin Hotels Chicago to Become Supplier of Gummy Products for Guest Room Mini-Bars

  • The Gummy Project's Peachy Bees and Watermelon Sharks expected to be featured for sale in all 250 guest rooms at the Virgin Hotel Chicago.
  • Purchase order continues The Gummy Projects strategic expansion in the Canadian and US Hotel sector.

The Gummy Project (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the Virgin Hotels Chicago to become a supplier of gummies for each of the hotel's 250 guest room mini-bars.

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AbbVie Highlights Robust Gastroenterology Portfolio with New Data in Crohn's Disease and Ulcerative Colitis at the UEG Week 2022

  • Final analyses from the U-ACHIEVE Phase 3 maintenance study of RINVOQ ® (upadacitinib) in moderately to severely active ulcerative colitis
  • Data highlighting symptomatic and endoscopic outcomes, delayed subcutaneous responders and predictors of response in patients receiving risankizumab (SKYRIZI ® ) for use in moderate to severe Crohn's disease *
  • Data from the Phase 3 study U-EXCEL evaluating the efficacy and safety of upadacitinib (RINVOQ ® ) as induction therapy for use in adults with moderately to severely active Crohn's disease *
  • A total of 17 abstracts, including seven oral presentations, reinforce AbbVie's commitment to research into developments that could help advance standards of care for patients living with inflammatory bowel disease (IBD)

ABBVie (NYSE: ABBV) today revealed the spectrum of new data from studies of risankizumab (SKYRIZI ® ) in Crohn's disease and upadacitinib (RINVOQ ® ) in ulcerative colitis and Crohn's disease that will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week 2022, October 8-11 in Vienna and online. In total, ABBVie is presenting 17 abstracts across a broad range of studies in inflammatory bowel disease (IBD).

"With two decades of world-class science and an unwavering commitment to patients, we continue to advance research within our robust gastro portfolio with the goal of positively impacting the lives of people living with inflammatory bowel disease," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "Our data at UEG Week 2022 reinforce our dedication to innovation and partnership with the gastroenterology community to help address a wide range of patient needs and investigate diverse solutions to help advance standards of care for IBD patients."

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Cardiol Therapeutics Announces Poster Presentation at The Annual Scientific Meeting of the Heart Failure Society of America

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The poster will be presented for general viewing within the "Basic and Translational Science" category of the HFSA2022 Scientific Programme on September 30, 2022, from 6:15 – 6:30 PM EDT.

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The Gummy Project Achieves Another Milestone with Purchase Order from Canada Life Centre, Home of the National Hockey League's Winnipeg Jets and American Hockey League's Manitoba Moose

The Gummy Project Achieves Another Milestone with Purchase Order from Canada Life Centre, Home of the National Hockey League's Winnipeg Jets and American Hockey League's Manitoba Moose

  • Purchase from an NHL sports and entertainment venue marks an important milestone in The Gummy Project's multi-channel sales strategy.
  • The Gummy Project's Peachy Bees and Watermelon Sharks will be featured for sale in all concessions, starting with the Winnipeg Jets pre-season home opener.
  • Peachy Bees and Watermelon Sharks now available in an NHL sports and entertainment venue, major grocery chains, a national airline, hotels (in both US and Canada) and one of the largest passenger ferry lines in the world.

The Gummy Project (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce it has received a purchase order from The Canada Life Centre, home of the National Hockey League's Winnipeg Jets and American Hockey League's Manitoba Moose.

"We are absolutely thrilled that our Peachy Bees and Watermelon Sharks will be available for fans to enjoy at Jets and Moose games," said Charlie Lamb, President & CEO of GUMY. "Our multi-channel sales strategy now includes high traffic sports and entertainment venues, with Canada Life Centre marking our entrance into this sector and a key milestone for the Company. In a very short time period, we have been able to form partnerships with and have our gummies for sale in major grocery chains, a national airline, hotels (both in the US and Canada), one of the largest passenger ferry systems in the world and now a professional sports stadium and we very much look forward to continuing to execute our strategic expansion both in Canada and the US."

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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 glaucoma 1
  • XEN 63 is a minimally invasive, micro-incisional glaucoma surgery designed to lower IOP 2
  • XEN 63 Gel Implant provides innovative treatment option for Canadians impacted by glaucoma

 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)

"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 approach 1 (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

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SOURCE AbbVie Canada

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