Irvine-based Ivantis Inc. said results from a two-year trial of its Hydrus Microstent show a clear advantage over rival, San Clemente-based Glaukos Corp. (NYSE: GKOS).
The Ivantis implant, which received Food and Drug Administration clearance in August, belongs to a category of glaucoma devices known as MIGS, or minimally invasive glaucoma surgery, designed to lower eye pressure for open-angle glaucoma patients.
The 152-patient, 12-international-center trial compared Ivantis’ Hydrus with the iStent Trabecular Micro-Bypass Stent from market leader Glaukos. Ivantis said the study was a pure head-to-head comparison of the devices as a standalone treatment for mild to late-moderate stage open-angle glaucoma.
Results showed 38% of patients treated with the Hydrus device were medication free, compared to 18.7% of patients in the iStent groups. Medication use was cut by 52% on average for Hydrus patients and 29% for iStent patients, Ivantis said.
The original primary outcome endpoint measured intraocular pressure reduction, according to published reports.
The Glaukos device used in the trial was its original iStent, which received FDA approval in mid-2012. The company’s latest device is the iStent Inject, approved by the regulatory agency last year. It’s commercially available in Europe and countries like Australia and Canada, with more than 30,000 implanted.
Glaukos filed patent infringement cases against Ivantis in April.
Hydrus, roughly the size of an eyelash, is a next-generation MIGS device that reduces eye pressure by reestablishing the flow through Schlemm’s canal, the eye’s natural fluid outflow pathway. More than 4,000 patients globally have been treated with it, according to the company.
The results provided some important and practical takeaways, according to Dr. Thomas Samuelson, president of the American Society of Cataract and Refractive Surgeons.
While the predominant application of MIGS today is in conjunction with cataract surgery, “the results of this trial allow us great optimism for the role of these technologies as ‘standalone’ procedures,” he said in a statement.
“Hydrus as a stand-alone procedure was excellent.”
Drugs take the lion’s share of the more than $5 billion global glaucoma market.
Both Ivantis and San Clemente-based Glaukos, which pioneered the technology, belong to a handful of minimally invasive surgical device makers. The latter has a $2.8 billion market cap.
Sabra Settlement OK’d
Sabra Health Care REIT Inc. (Nasdaq: SBRA) said a bankruptcy court approved a settlement between the company and Senior Care Centers.
The Irvine-based senior housing real estate owner last November cut ties with its largest operator, which is based in Dallas. Senior Care Centers filed for bankruptcy in December.
“The continued instability of management and inability to execute really validated the concerns we had earlier this year that we needed to do something about the Senior Care portfolio,” Sabra Chief Executive Rick Matros told investors on a conference call.
Sabra plans to sell 28 facilities run by Senior Care for $282.5 million. Based on the settlement, the REIT will also discharge claims against the operator in exchange for a $9.5 million settlement payment and its help in facilitating the transfer of those sale assets, a statement said.
Sabra has a $3.4 billion market cap.
Buyers: Allergan, Smile Brands
• Allergan PLC (NYSE: AGN) bought Envy Medical Inc., a privately held medical aesthetics company. Envy’s Dermalinfusion, a non-surgical, non-invasive skin resurfacing system for the face and body was folded into Allergan’s Irvine-based medical aesthetics portfolio.
The technology “appeals to millennials and their focus on skin quality,” Carrie Strom, senior vice president of U.S. medical aesthetics at Allergan said in a statement.
Envy also has a complete line of skincare products to complement Allergan’s portfolio.
• Irvine-based Smile Brands Inc., a portfolio company of San Francisco-based private equity firm Gryphon Investors, last month bought Seattle, Wash.-based Gateway Dental on undisclosed terms. Smile Brands is a dental support organization providing services such as purchasing, payroll, accounting, IT and billing. It’s one of the largest DSOs in the U.S. with more than 400 affiliated offices across 17 states.
‘Gutsy’ NB Firm in Mayo Trial
Newport Beach-based ImmunogenX began a Phase II clinical trial of its lead therapeutic and diagnostic candidates Latigutenase and CypCel last month. The study, sponsored by the National Institutes of Health, will be conducted at the Mayo Clinic in Rochester, Minn.
The clinical-stage company develops treatments for celiac disease, an immunity malady that helped spawn the ‘gluten-free’ trend. Lead drug candidate Latigutenase aims to protect intestinal health and reduce gluten-induced symptoms; diagnostic tool CypCel measures patient response to treatment.
Chief Executive Jack Syage said the drug and diagnostic tool are “independent developments … not companions.”
