GENEVA--(BUSINESS WIRE)--Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the closing of its previously announced acquisition of Ivantis®, developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure for open-angle glaucoma patients in connection with cataract surgery.*
With this acquisition, the immediate integration of Ivantis associates helps ensure continuity of the business and relationships with existing customers. It also allows Alcon to begin its future growth plans to bring Hydrus Microstent to more international markets and prioritize its ongoing evidence-based research.
“We believe this transaction will further strengthen our global surgical portfolio and help provide a platform for more growth in the glaucoma space,” said David Endicott, CEO of Alcon. “As we welcome Ivantis associates into Alcon, we look forward to introducing Hydrus Microstent on a broader, global scale in the near future to help even more patients see brilliantly.”
Longstanding clinical safety and efficacy data, which will be highlighted at 2022 medical meetings, is a cornerstone of Hydrus Microstent and its market adoption to date. Its five-year HORIZON data demonstrated clinically meaningful and statistically significant clinical benefits over the full five years, including sustained reduction in medication use and the need for invasive secondary glaucoma surgery. The safety profile was also sustained through the five-year follow-up.1
“This is an important time for Hydrus Microstent as we continue to learn more about its long-term efficacy and outcomes for glaucoma patients worldwide. The visual field data recently showcased at the American Academy of Ophthalmology annual meeting showed Hydrus Microstent as the first MIGS device to demonstrate a reduced rate of visual field loss compared to cataract surgery alone. This is an important milestone for surgeons and their patients,” said Dr. Ike Ahmed, Research Director at Kensington Eye Institute, Director of the Glaucoma and Advanced Anterior Segment Surgery (GAASS) Fellowship Program at the University of Toronto, and Professor of Ophthalmology and Visual Sciences at the University of Utah’s John A. Moran Eye Center. “I am confident that Alcon’s acquisition of Ivantis will help drive even more research and adoption of Hydrus Microstent.”
Continuing this rigorous ongoing research, Alcon plans to pursue stand-alone surgery indications for Hydrus Microstent in the U.S. with clinical trials underway and additional information about potential expansion plans will be provided in the future.
In the U.S., Hydrus Microstent, which is part of a large and growing market, is currently indicated for the reduction of intraocular pressure in adult patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. In the U.K., Canada, Australia, Singapore and Germany, the device is indicated for primary open-angle glaucoma in conjunction with cataract surgery and as a stand-alone procedure.
About Alcon
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases, and refractive errors. Our more than 23,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.
About Hydrus Microstent
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm's canal, the eye's natural outflow pathway. When placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid in the eye, using a Tri-Modal® mechanism of action: the Hydrus Microstent dilates and scaffolds Schlemm's canal to augment outflow of aqueous humor from the anterior chamber. It maintains an opening through the trabecular meshwork from the anterior chamber into Schlemm's canal. Its length spans approximately 90 degrees of the canal to provide consistent access to multiple fluid collector channels in the eye. Approved by the FDA in August 2018 for use in conjunction with cataract surgery, the Hydrus Microstent is one of the most rigorously researched and thoroughly studied MIGS devices.
References
- Ahmed, I.K. (2021, Mar. 4-7). 5 Year Follow Up from the HORIZON Trial. American Glaucoma Society Virtual Annual Meeting.
- Gazzard et al. AGS 2022 Abstract (in review).
*Currently approved for stand-alone use and commercialized in the U.K., Canada, Australia, Singapore and Germany.
Forward-looking Statements
This press release contains, and our officers and representatives may from time to time make, certain “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements Alcon makes regarding its plans and decisions relating to the acquisition of Ivantis Inc. and the manufacture, distribution, marketing and/or sale of the Hydrus® Microstent; the ability of Alcon to execute on these plans; market growth assumptions; and generally, its expectations concerning its future performance.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Alcon’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict such as: the effect of the COVID-19 pandemic as well as other viral or disease outbreaks and the availability and the public’s acceptance of vaccines; the commercial success of its products and its ability to maintain and strengthen its position in its markets; the success of its research and development efforts, including its ability to innovate to compete effectively; its success in completing and integrating strategic acquisitions; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; transaction costs; pricing pressure from changes in third party payor coverage and reimbursement methodologies; global and regional economic, financial, legal, tax, political, and social change; data breaches or other disruptions of its information technology systems; ongoing industry consolidation; its ability to properly educate and train healthcare providers on its products; changes in inventory levels or buying patterns of its customers; the impact of a disruption in its global supply chain or important facilities; ability to service its debt obligations; its ability to comply with the US Foreign Corrupt Practices Act of 1977 and other applicable anti-corruption laws, particularly given that it has entered into a three-year Deferred Prosecution Agreement with the US Department of Justice; uncertainty and impact relating to the potential phasing out of LIBOR and transition to alternative reference rates; the need for additional financing through the issuance of debt or equity; its reliance on outsourcing key business functions; its ability to protect its intellectual property; the impact of unauthorized importation of its products from countries with lower prices to countries with higher prices; uncertainties regarding the success of Alcon's separation and Spin-off from Novartis and the subsequent transformation program, including the expected separation and transformation costs, as well as any potential savings, incurred or realized by Alcon; the effects of litigation, including product liability lawsuits and government investigations; its ability to comply with all laws to which it may be subject; effect of product recalls or voluntary market withdrawals; the implementation of its enterprise resource planning system; its ability to attract and retain qualified personnel; the accuracy of its accounting estimates and assumptions, including pension plan obligations and the carrying value of intangible assets; the ability to obtain regulatory clearance and approval of its products as well as compliance with any post-approval obligations, including quality control of its manufacturing; legislative and regulatory reform; the ability of Alcon Pharmaceuticals Ltd. to comply with its investment tax incentive agreement with the Swiss State Secretariat for Economic Affairs in Switzerland and the Canton of Fribourg, Switzerland; its ability to manage environmental, social and governance matters to the satisfaction of its many stakeholders, some of which may have competing interests; its ability to operate as a stand-alone company; whether the transitional services Novartis has agreed to provide Alcon are sufficient; the impact of the spin-off from Novartis on Alcon's shareholder base; the impact of being listed on two stock exchanges; the ability to declare and pay dividends; the different rights afforded to its shareholders as a Swiss corporation compared to a US corporation; and the effect of maintaining or losing its foreign private issuer status under US securities laws. Additional factors are discussed in Alcon’s filings with the United States Securities and Exchange Commission, including its Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.
Forward-looking statements in this press release speak only as of the date of its filing, and Alcon assumes no obligation to update forward-looking statements as a result of new information, future events or otherwise.
