Elios Vision, Inc. has completed patient enrollment for its pivotal trial assessing the use of the ELIOS procedure in combination with cataract surgery to reduce intraocular pressure (IOP).
Refresh me on the company first.
Founded in 2019 and based in Los Angeles, California, Elios Vision is a privately-held company focused on developing a safe and effective breakthrough technology as a solution for preserving sight in glaucoma patients through its ELIOS technology.
Talk about this technology.
The ELIOS technology combined with phacoemulsification operates as a microinvasive, implant-free procedure that uses excimer laser light energy to create 10 microscope openings (200 µm) within the trabecular meshwork (TM) to reestablish the flow of aqueous humor into Schlemm’s canal.
What marks it unique?
Compared to other forms of microinvasive glaucoma surgery (MIGS), the use of an excimer laser can lower the complexity of both intra- and post-op surgery—due to its avoidance of thermal or mechanical trauma thereby potentially shortening healing time.
Any prior clinical data on it?
Yup! The company released results in 2022 from an eight-year follow-up of a cohort study on ELIOS in patients with glaucoma or ocular hypertension and cataract.
The data demonstrated a sustained IOP reduction (19.3 mmHg at baseline to 15.4 mmHg; p = 0.0040) and lower medication needs, with only 3.7% of patients requiring secondary surgical glaucoma intervention during the follow-up period.
Any other credibility to it?
Actually … the ELIOS has already received a CE mark in Europe—based on 12 clinical studies which have illustrated both efficacy and a favorable safety profile where it can be indicated for the treatment of glaucoma with or without cataract surgery.
More recently, it has been registered for use in the United Kingdom and France.
So what do we know about this new study?
According to Elios Vision, the pivotal trial (NCT04899063) is enrolling an estimated 318 patients (ages 45+) diagnosed with mild-to-moderate primary open-angle glaucoma (POAG) with the following criterias:
- Medicated IOP of <24 mmHg
- Unmedicated diurnal IOP (DIOP) of >22 mmHg and <34 mmHg
- BCVA of 20/40 or worse
See here for the complete list.
What’s being measured?
The study’s primary outcome measure is the number of patients who achieve a decrease in medication-free mean DIOP from baseline of at least 20% over a 24-month period.
Secondary outcome measure is the mean change in medication-free DIOP from baseline (within 24-month period).
When can we expect data?
Per Clinical Trials.gov, the study is estimated for completion by July 2024.
Stay tuned for data releases in the meantime!
Any other updates to know about?
Actually … the company announced they’ve also added to their U.S. executive team to assist in the company’s plans for a FDA marketing submission of ELIOS:
- Frank Shield → President of the Americas (previously at Bausch + Lomb, Chiron, Johnson & Johnson, and Ivantis)
- Cari Stone → Senior Vice President of Marketing (formerly of Allergan and Alcon)
- John Liu → Senior Vice President of Reimbursement & Market Access (formerly of Sight Sciences, Alcon, and Allergan)