Life Science News

- Seven abstract presentations showcase ongoing research in presbyopia and glaucoma

Allergan, an ABBVie (NYSE: ABBV) company, announced that it will present new data on VUITY ™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only FDA-approved eye drop for the treatment of presbyopia (age-related blurry near vision) in adults, and DURYSTA® (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients, at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 1-4 in Denver, CO.

"The variety of data we will present will shed light on our continued commitment to innovate in the areas of presbyopia and glaucoma. We are looking forward to unveiling important studies on both VUITY and DURYSTA to show the advances we are making for those living with these conditions," said Michael R. Robinson , M.D., vice president, global therapeutic area head, ophthalmology, AbbVie.

At the meeting, researchers will present new data on VUITY, a once-daily, prescription eye drop that improves near and intermediate vision without compromising distance vision in patients with age-related blurry near vision. The presentation data will include results from the GEMINI studies on pupil size, depth of focus, and duration of efficacy among other important trial outcomes. Presbyopia is a common and progressive eye condition that reduces the eye's ability to focus on near objects. It usually impacts people after age 40, affecting approximately 128 million Americans or nearly half of the U.S. adult population.

In addition, attendees will learn of new research findings on DURYSTA. The presentation will focus on the duration of intraocular pressure (IOP) control following DURYSTA administration.

A complete listing of the Allergan ARVO 2022 Annual Meeting abstracts can be viewed at: https://arvo2022.arvo.org/abstracts .

Details about Allergan's presentations are as follows:

Abstract

Linked to ARVO program

Presentation Details

All Times EDT

Presbyopia

Plasma pharmacokinetics of pilocarpine in participants administered VUITY (pilocarpine HCl ophthalmic solution) 1.25%

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1808 – F0424

Optimal pupil size for near-vision improvement without distance-vision loss in the GEMINI studies of AGN-190584 in presbyopia

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1810 – F0426

Corneal Permeability of Pilocarpine HCl 1.25% with Varying pH Formulations

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1814 – F0430

Extended Depth of Focus from AGN-190584 in GEMINI 1 and GEMINI 2 Pooled Phase 3 Studies

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1812 – F0428

No Impact of Headache or Visual Impairment Adverse Events following AGN-190584 Observed on Patient Reported Outcomes

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1815 – F0431

Duration of Efficacy of AGN-190584 on Photopic Distance-Corrected Intermediate Visual Acuity in the GEMINI 1 and GEMINI 2 Pooled Phase 3 Studies

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1811 – F0427

Glaucoma

Longevity of IOP Control Post Single Bimatoprost Implant Injection in a Phase 3b Study

Session: Clinical Studies and Trials
Wednesday, May 4, 2022

12:34 PM to 12:51 PM

Room 601/603 Denver Convention Center

About VUITY
VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast™ technology, which allows VUITY to rapidly adjust to the physiologic pH of the tear film. This was studied in simulated tear film, and the clinical significance is unknown. VUITY uses the eye's own ability to reduce pupil size and improves near and intermediate vision without compromising distance vision.

VUITY Use and Important Safety Information

USE
VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults.

IMPORTANT SAFETY INFORMATION

  • Do not use VUITY if you are allergic to any of the ingredients.
  • Use caution when driving at night or performing hazardous activities in poor lighting.
  • Temporary problems when changing focus between near and distant objects may occur. Do not drive or use machinery if vision is not clear.
  • Seek immediate medical care if you experience any sudden vision loss.
  • If you wear contact lenses, they should be removed prior to VUITY use. Wait 10 minutes after dosing before reinserting contact lenses.
  • Do not touch the dropper tip to any surface as this may contaminate the contents.
  • If more than one topical eye medication is being used, the medicines must be administered at least 5 minutes apart.
  • The most common side effects are headache and eye redness. These are not all the possible side effects of VUITY.

Please see full Prescribing Information at www.VUITY.com or call 1-833-MY-VUITY.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

DURYSTA® Consumer Indications and Usage and Important Safety Information

Approved Uses
DURYSTA® (bimatoprost intracameral implant) is a prescription medicine to reduce eye pressure (also called intraocular pressure, or IOP) in patients with open angle glaucoma or high eye pressure (ocular hypertension).

IMPORTANT SAFETY INFORMATION
DURYSTA® should not be used if:

  • You have any infection or suspected infection in your eye or surrounding eye area
  • You have corneal endothelial cell dystrophy, a condition in which the clear front layer of your eye (cornea) has lost its ability to work normally and can cause vision problems
  • You have had a corneal transplant or cells transplanted to the inner layer of the cornea (endothelial cell transplant)
  • The sack that surrounds the lens of your eye (posterior lens capsule) is missing or torn
  • You are allergic to any of its ingredients

DURYSTA® may cause side effects involving the cornea, including increased risk of loss of cells from the inner layer of the cornea. You should not receive DURYSTA® more than once in each eye. DURYSTA® should be used with caution if you have a limited reserve of the cells lining the inner layer of the cornea.

DURYSTA® should be used with caution if you have narrow or obstructed iridocorneal angles (the space where the iris, the colored part of the eye, and cornea meet).

DURYSTA® may cause swelling of the macula, the center spot of the retina (back of the eye). DURYSTA® should be used with caution if your eye does not have a lens, if you have an artificial lens and a torn posterior lens capsule, or if you have any risk factors for swelling of the macula.

DURYSTA® may cause inflammation inside the eye or make existing inflammation worse.

DURYSTA® may cause increased brown coloring of the iris, which may be permanent.

Eye injections have been associated with infections in the eye. It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye redness, sensitivity to light, eye pain, or a change in vision, after an injection. Your doctor should monitor you following DURYSTA® administration.

The most common side effect involving the eyes reported in patients using DURYSTA® was eye redness. Other common side effects reported were: feeling like something is in your eye, eye pain, being sensitive to light, a blood spot on the white of your eye, dry eye, eye irritation, increased eye pressure, a loss of cells on the inner layer of the cornea, blurry vision, inflammation of the iris, and headache.

Please see full Prescribing Information available at www.Durysta.com .

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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.

About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion.

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 our 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 2021 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.

Cision View original content: https://www.prnewswire.com/news-releases/allergan-an-abbvie-company-to-present-new-data-from-its-leading-portfolio-of-eye-care-treatments-at-the-2022-association-for-research-in-vision-and-ophthalmology-arvo-annual-meeting-301534802.html

SOURCE AbbVie

News Provided by PR Newswire via QuoteMedia

ABBV

Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be 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, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
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,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. 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.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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ABBV SHAREHOLDER ALERT: ROSEN, TRUSTED AND TOP RANKED INVESTOR COUNSEL, Encourages AbbVie Inc. Investors with Losses to Secure Counsel Before Important June 6 Deadline in Securities Class Action - ABBV

-

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline .

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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of ABBV, MYPS and ARQQ

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

ABBVie Inc. (NYSE:ABBV)
Class Period: April 30, 2021 - August 31, 2021
Lead Plaintiff Deadline: June 6, 2022

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CLASS ACTION UPDATE for ABBV, SDIG and AUPH: Levi & Korsinsky, LLP Reminds Investors of Class Actions on Behalf of Shareholders

Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court. Further details about the cases can be found at the links provided. There is no cost or obligation to you

ABBV Shareholders Click Here: https://www.zlk.com/pslra-1/abbvie-inc-loss-submission-form?prid=27797&wire=1
SDIG Shareholders Click Here: https://www.zlk.com/pslra-1/stronghold-digital-mining-inc-loss-submission-form?prid=27797&wire=1
AUPH Shareholders Click Here: https://www.zlk.com/pslra-1/aurinia-pharmaceuticals-inc-information-loss-submission-form?prid=27797&wire=1

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Komo Plant-Based Foods Appoints US Sales Management Consultants

Komo Plant-Based Foods Appoints US Sales Management Consultants

Komo Plant Based Foods Inc. (CSE:YUM)(OTCQB:KOMOF)(FRA:9HB) ("Komo") is pleased to announce the appointment of a U.S. sales consultant, Caboodle Consulting LLC (Caboodle), to develop Komo's retail expansion throughout the United States. Komo will work closely with the Caboodle sales management team to build out the US retail strategy. Heather Barry Whittier will be representing Komo as the Director of Sales. Ms. Whittier has 20+ years experience in the natural products industry including a pivotal role in growing a brokerage, Yin Yang Naturals, from regional to national coverage

Other members of the Caboodle management team include Lisa Thorson and Constance Wolfe. Lisa Thorson comes from a Market Analysis background with 10+ years' experience in Consumer Packaged Goods (CPG) brokerage and brand management with experience at Laird Superfood and Alliance Sales & Marketing. Constance Wolfe offers 10+ years of brand management experience including specializing in data analysis and trade spend promotional management with experience at Coconut Bliss and Hilary's Eat Well.

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib in Ulcerative Colitis

ABBVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE (maintenance) evaluating upadacitinib (RINVOQ ® ) in patients with moderately to severely active ulcerative colitis who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by regulatory agencies. The publication reports the efficacy and safety results of the two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral upadacitinib versus placebo over 8 weeks and 52 weeks, respectively. 1

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab in Crohn's Disease

ABBVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) evaluating risankizumab (SKYRIZI ® ) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by the global health authorities. The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks. 1 The publication of FORTIFY shares the results of the maintenance study evaluating the safety and efficacy of subcutaneous (SC) risankizumab versus placebo (the withdrawal from IV risankizumab) over 52 weeks in patients who achieved clinical response during the ADVANCE and MOTIVATE studies. 2

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