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Devices Ophthalmology

 News Release - July 20, 2022

AbbVie and iSTAR Medical Announce Strategic Alliance for the Treatment of Glaucoma

Alliance will provide opportunity for AbbVie to further expand its diverse eye care portfolio and provide additional treatment options for glaucoma patients

Collaboration further supports the role of MINIject® in the treatment of glaucoma and accelerates goal to bring MINIject to more patients globally

Deal terms include a $60M upfront payment to iSTAR Medical

iSTAR Medical to continue development and commercialization of the MINIject device up to completion of the U.S. PMA study


NORTH CHICAGO, Ill. and WAVRE, Belgium, July 20, 2022 -- (Healthcare Sales & Marketing Network) -- AbbVie (NYSE: ABBV) and iSTAR Medical SA, today announced a strategic transaction to further develop and commercialize iSTAR Medical's MINIject® device, a minimally invasive glaucoma surgical (MIGS) device for patients with glaucoma. This complementary alliance will support iSTAR Medical's development and commercial efforts for MINIject®, as well as provide an opportunity to expand AbbVie's eye care business, building on its glaucoma portfolio which includes drops, sustained release implants, and stent offerings.

MINIject® received Conformité Européenne (CE) marking approval to commercialize in European countries in the last quarter of 2021 and launched commercially in select European countries in early 2022. iSTAR Medical is currently enrolling a U.S. Premarket Approval study (STAR-V) to enable commercialization in the U.S.

"As a leading company in eye care with a commitment to a broad and diverse portfolio from the front to the back of the eye, along with our global footprint and infrastructure in glaucoma, we are well-positioned to support bringing this MIGS offering to patients and glaucoma specialists through this strategic alliance," said Michael Robinson, M.D, Vice President, Global Therapeutic Area Head of Eye Care, AbbVie. "This alliance with iSTAR Medical is an important step as we continue to be an innovator in glaucoma by maximizing the value of interventional approaches throughout the treatment paradigm."

"Today's announcement is validation of the transformational role of MINIject in the treatment of glaucoma," said Michel Vanbrabant, Chief Executive Officer, iSTAR Medical. "Our commitment has always been to enable more glaucoma patients globally to be treated effectively in a minimally-invasive manner with our MINIject® MIGS device, and this alliance accelerates that goal, especially in the United States. We will benefit from AbbVie's strong global experience and knowledge base already established in glaucoma, and we are excited to be working with such a world class team."

Under the terms of the agreement, iSTAR Medical will receive a $60M non-dilutive upfront payment and will continue to develop and commercialize MINIject® until completion of the STAR-V clinical study. AbbVie will hold the exclusive right to acquire iSTAR Medical and lead subsequent global development and commercialization of the MINIject device. If AbbVie exercises the right to acquire iSTAR, the stockholders of iSTAR Medical would also be eligible to receive additional contingent payments of up to $475M in a closing payment and upon achievement of certain predetermined milestones.

iSTAR Medical will remain an independent company through the completion of the STAR-V study. This financing will support the continued development and commercialization of MINIject®, including ongoing clinical studies and further enhancements to the technology. SVB Securities LLC acted as financial advisor to iSTAR Medical.

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 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

About iSTAR Medical

iSTAR Medical is committed to delivering breakthrough eye care solutions. Our most advanced product, MINIject®, is approved in Europe for the treatment of open-angle glaucoma – the leading cause of irreversible blindness – and we are aiming to seek market approval in the US. We believe MINIject®'s distinctive tissue-integrating capabilities unlock a safer, and more effective option for patients. We are building an exceptional team and pipeline of innovative products such as MINIject® to establish new treatment paradigms in eye care conditions with the highest patient needs. For more information, please visit: www.istar-medical.com

About MINIject®

MINIject® is iSTAR Medical's innovative MIGS device for patients with primary open-angle glaucoma. MINIject® combines the distinctive porous structure of its proprietary STAR® material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.

About Glaucoma

Glaucoma is a progressive disease affecting over 100 million people globally, of which primary open-angle glaucoma is the most common form.1,2 IOP reduction, through medication or surgery, helps delay disease progression.3 Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.1,3 More invasive surgical options can present risks with irreversible complications and often requires long-term patient management.1,3 MIGS is one of the most promising and fastest-growing glaucoma therapies due to the potential for an enhanced safety profile.1

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.

1 Market Scope, "2021 Glaucoma Surgical Device Market Report", July 2021. https://www.market-scope.com/pages/reports/267/2021-glaucoma-surgical-device-market-report

2 Jonas JB, Aung T, Bourne RR et al. "Glaucoma". Lancet 2017; 390: 2083–93

3 "European Glaucoma Society Terminology and Guidelines for Glaucoma", 4th Edition: British Journal of Ophthalmology. 2017;101:1-195 https://bjo.bmj.com/content/101/5/73


Source: AbbVie

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