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

IRVINE, Calif., June 28, 2023 /PRNewswire/ -- Today, Elios Vision Inc., an ophthalmic device company focused on preserving vision by increasing microinvasive glaucoma surgery (MIGS) adoption, announced it has completed enrollment for its pivotal trial of more than 300 patients with mild to moderate glaucoma treated with the ELIOS^® procedure in combination with cataract surgery. ELIOS is an implant-free procedure that uses next generation excimer laser technology for the treatment of glaucoma.

"This is a key milestone in our clinical plans as we bring the ELIOS procedure one step closer to patients suffering from glaucoma, a leading cause of blindness," said S. Arieh Zak, Elios Vision Senior VP, Regulatory/Clinical/Quality. "We are grateful to our clinical investigators and the internal team's combined dedication and diligence, and we look forward to our FDA marketing submission in the U.S."

In addition to completing trial enrollment, Elios Vision announced significant additions to the U.S. executive team:

• Frank Shields has been named President of the Americas where he will hire and lead the U.S. sales organization. Frank has more than 30 years of experience in eyecare with previous roles at Bausch & Lomb, Chiron, J&J, and Ivantis where he launched the Hydrus^® Microstent MIGS device.
• Cari Stone has been named Senior Vice President of Marketing, leading marketing efforts for the U.S. launch. Cari has more than 20 years of experience leading businesses and launching products in medical devices, pharmaceuticals, and biotech. Cari has spent the last decade in ophthalmology, with previous roles at Allergan and Alcon, where she was responsible for the acquisition and integration of Ivantis.
• John Liu has been appointed Senior Vice President of Reimbursement & Market Access. John has more than 25 years of reimbursement experience across medical device, pharmaceutical, and biotech and has held prior roles at Sight Sciences, Alcon, and Allergan where he launched DURYSTA^®.

While seeking FDA approval and expanding the team in preparation for U.S. commercialization, Elios Vision has built significant traction in Europe, where the technology has a CE mark and is indicated for the treatment of glaucoma with or without cataract surgery. European surgeons have performed the ELIOS^® procedure on thousands of eyes and contributed to 20 academic publications by 36 authors including 2,300 study eyes – with follow up going out to more than 8 years ^1,2,3.

European eyecare veteran, Cameron Hudson, OD, PhD leads the Elios Vision Europe team of 20 employees and reports strong commercial uptake and surgeon feedback on the ELIOS^® procedure.

"There is clear momentum for the ELIOS procedure across European markets. The ELIOS excimer laser technology is an attractive and widely adoptable option at the time of cataract surgery for glaucoma and cataract surgeons, and it avoids the need for an implant," said Keith Barton, MD, FRCP, FRCS, FRCOphth, University College London and Moorfields Eye Hospital, London.

This week, the Elios Vision Europe team will present the latest clinical data and surgeon experience and showcase the ELIOS procedure during dry lab sessions and symposia at the World Glaucoma Congress in Rome.

"Completing enrollment of our U.S. 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. "In Europe, we are already seeing that the ELIOS technology has the profile to reach the thousands of glaucoma and cataract surgeons currently performing cataract surgery, but not providing MIGs to their glaucoma patients. Our world class team and KOL's in Europe and the U.S. 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."

About Elios Vision Inc.
Elios Vision Inc. is a privately held company, working to preserve sight by developing a safe and effective breakthrough solution for the millions of patients who have glaucoma. The ELIOS technology has a CE mark and has been used for a decade in Europe with thousands of patients treated. In the United States, the technology is investigational and undergoing an IDE pivotal trial.

Elios Vision website:
www.eliosvision.com

References:

1. Riesen M, Funk J, Töteberg-Harms M. Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year follow-up study. Graefes Arch Clin Exp Ophthalmol. Published online January 16, 2022. doi:10.1007/s00417-021-05510-8.
2. Durr GM, Töteberg-Harms M, Lewis R, Fea A, Marolo P, Ahmed IIK. Current review of Excimer laser Trabeculostomy. Eye Vis (Lond). 2020 May 5;7:24. doi: 10.1186/s40662-020-00190-7. PMID: 32391398; PMCID: PMC7199329.
3. Moreno Valladares A, Puerto Amorós N, Mendez Llatas M, Pazos López M, Ahmed IIK. Combined excimer laser trabeculostomy and phacoemulsification: one year follow-up real world data of a laser-based MIGS. Arch Soc Esp Oftalmol (Engl Ed). 2021 Mar 11:S0365-6691(21)00053-8.

SOURCE Elios Vision Inc.