Elios Vision completes enrollment for pivotal US clinical trial

Article

The company seeks to replicate European success of the ELIOS procedure in the US market.

A close-up of an eye with a digital scanner overlay on the surface. Image credit: ©muratart – stock.adobe.com

Elios Vision seeks to bring its European momentum to the US market. Image credit: ©muratart – stock.adobe.com

Ophthalmic device company Elios Vision, which specialises in microinvasive glaucoma surgery (MIGS) adoption, announced a “pipeline milestone” ahead of a pivotal trial in the United States. According to a press release, the company has completed enrollment for a trial of more than 300 patients with mild to moderate glaucoma. These patients will be treated with the implant-free ELIOS procedure, in combination with cataract surgery.1

The enrollment milestone reflects Elios Vision’s focus on bringing the ELIOS excimer laser technology to the US market.1 Currently, Elios Vision is seeking FDA approval and adding team members ahead of US commercialisation. Earlier this year, Elios Vision announced it had registered the ELIOS technology in the United Kingdom; last December, the company registered its technology in France.

The company acknowledged its success throughout Europe in the press release, with commentary from Keith Barton, MD, FRCP, FRCS, FRCOphth, University College London and Moorfields Eye Hospital, London. “There is clear momentum for the ELIOS procedure across European markets,” Dr Barton said.1 “The ELIOS excimer laser technology is an attractive and widely adoptable option at the time of cataract surgery for glaucoma and cataract surgeons."

At the World Glaucoma Congress in Rome this week, the Elios Vision Europe team will present clinical data and showcase the signature ELIOS procedure during dry lab sessions, the company announced.1

Alongside the trial enrollment news, Elios Vision recognised additions to the US executive team. Frank Shields, previously at Bausch & Lomb, J&J and Ivantis, will lead US sales as President of the Americas. Cari Stone will serve as Senior Vice President of Marketing, bringing 20 years' experience in medical devices, biotech and pharmaceuticals. Finally, John Liu was named Senior Vice President of Reimbursement and Market Access. With previous roles at Alcon, Sight Sciences and Allergan, Liu brings 25 years' experience to the executive team.

“Completing enrollment of our US clinical trial marks a significant milestone on our journey to advancing the global standard of care in glaucoma,” said Elliot Friedman, Elios Vision Chairman and CEO.1 “Our world class team and KOL’s in Europe and the US allow Elios Vision to establish a significant next generation MIGS treatment that is implant-free, preserves tissue and has many independent clinical studies demonstrating the powerful efficacy and safety that you would expect from an excimer laser treatment.”

Reference

  1. Elios Vision Achieves Pipeline Milestone with Enrollment Completion in U.S. Pivotal Trial, Expands U.S. Pre-launch Team, and Continues to Generate Commercial Uptake in Europe. News release. Elios Vision, Inc., June 28, 2023. https://www.biospace.com/article/releases/elios-vision-achieves-pipeline-milestone-with-enrollment-completion-in-u-s-pivotal-trial-expands-u-s-pre-launch-team-and-continues-to-generate-commercial-uptake-in-europe/
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