Five-year-data from a pivotal trial of Ivantis’s minimally invasive glaucoma surgery (MIGS) device is favorable. The Irvine, CA-based company will unveil data from the HORIZON trial, which evaluated the Hydrus Microstent, at the upcoming American Glaucoma Society virtual meeting.
There were about 556 patients in HORIZON with mild to moderate glaucoma treated in 38 centers in nine countries in North America, Europe, and Asia. Results from HORIZON show sustained reduction in the need for invasive secondary glaucoma surgery and medication use, all of which were observed without any increased safety risk.
Key findings show:
- 73% of "mild" Hydrus Microstent patients (those on one glaucoma medication at baseline) remained medication-free at five years, compared with 48% in the cataract-surgery-alone arm. This represents the highest margin total of medication eliminations compared to a control group reported for any MIGS pivotal trial. There was a 20% to 30% improvement in the medication-free rate in the Hydrus group vs. controls at all time points.
- A 2.5% rate of subsequent invasive glaucoma surgery with the Hydrus Microstent, compared with 6.4% for cataract surgery alone. This equals a 2.8x, or over 60%, reduction in the likelihood for requiring subsequent invasive glaucoma surgery and is a clinically meaningful and statistically significant difference.
- The overall safety profile is similar for both groups. This includes continued stability of endothelial cell counts as well as rates of persistent inflammation (0.5% Hydrus vs. 2.1% cataract surgery alone).
Ivantis won a nod from FDA for the Hydrus Microstent in 2018.
By the Way, What Ever Happened to the MIGS 6?
A handful of companies, often referred to as the MIGS SIX, once comprised the invasive glaucoma surgery space. Ivantis is one of the few MIGS SIX companies that hasn’t been acquired by a larger firm.
Allergan kicked off consolidation in the MIGS space when it picked up Aquesys and the Xen stent for about $300 million in cash. Istar Medical and Glaukos are the other standalone companies in MIGS. Santen Pharmaceutical doled out about $225 million for Miami-based Innfocus.
In 2016, Novartis acquired Transcend Medical – developer of the CyPass stent for Alcon. But the following years would be a wild ride for the Cypass. Novartis would announce it would spin out Alcon into a publicly-traded company in 2018. Before the separation could become a done deal, Alcon pulled the CyPass stent from the market, after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone.
Glaukos has taken up the lion share of the market space for MIGS, but competition has had an impact. Glaukos’s CFO Joe Gilliam spoke about the state of the MIGS competitive landscape during the company’s most recent earnings call.
“We feel good about our product introduction in the form of iStent inject W and generally our access to accounts and the relationships that we have there and what that's meant for our business,” Gilliam said, according to a Seeking Alpha transcript of the earnings call. “So, what we're saying is, I think, if you look back vs. a year ago and how things have transpired, we feel like that competitive landscape, noise, if you will, has settled a bit and is much more stable relative to sitting here 12 months ago.”