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July 21, 2022

AbbVie and iSTAR partner to develop and market MINIject device

MINIject significantly reduces intraocular pressure and enhances natural fluid outflow.

AbbVie has announced a strategic alliance with iSTAR Medical for the further development and commercialisation of the latter’s MINIject device, designed to treat patients with glaucoma.

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The minimally invasive glaucoma surgical (MIGS) device has been designed to reduce intraocular pressure (IOP) by increasing the natural fluid outflow from the anterior chamber to the supraciliary space.

It combines the distinctive porous structure of iSTAR Medical’s proprietary STAR material with the power offered by the supraciliary space.

Under the partnership deal terms, iSTAR Medical will receive a non-dilutive upfront payment of $60m from AbbVie and be responsible for the development and commercialisation of MINIject until completion of the US Premarket Approval study (STAR-V).

AbbVie stated that the collaboration will support MINIject’s role in glaucoma treatment and expedite its availability to more patients across the world.

Through this deal, the company will have the exclusive right to acquire iSTAR Medical and lead the global development and roll out of the MIGS device.

If the company executes its rights for the acquisition, iSTAR Medical’s shareholders will receive up to $475m additional contingent payments upon achieving certain predetermined milestones.

Until completion of the STAR-V study, iSTAR Medical will operate as an independent entity.

AbbVie stated that the complementary alliance will allow it to further expand its eye care portfolio and offer additional treatment options for glaucoma patients.

AbbVie vice-president and eye care global therapeutic area head Michael Robinson said: “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.

“This alliance with iSTAR Medical is an important step as we continue to be an innovator in glaucoma by maximising the value of interventional approaches throughout the treatment paradigm.”

In the last quarter of 2021, iSTAR Medical secured CE marking for the commercialisation of MINIject in European countries.

The device was commercially launched in select European countries earlier this year.

At present, the company is enrolling participants in the STAR-V trial, with an aim to commercialise the MINIject device in the US in the future.

Last July, iSTAR Medical received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence a clinical trial of MINIject.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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