Hopes are high for Irvine-based Ivantis Inc., which anticipates receiving market approval from the Food and Drug Administration next year for its Hydrus Microstent. The micro implant is designed to lower eye pressure in open-angle glaucoma patients. Chief Executive Dave Van Meter said that thus far the initial acceptance and filing review responses have been positive.
Open-angle glaucoma, the most common form of the disease, is caused by blockage inside the eye that results in fluid accumulation and buildup of high pressure. The pressure damages the optic nerve, causing blurred vision, severe eye and head pain and eventual blindness. Ivantis’ technology, which is able to be performed during cataract surgery, relieves intraocular pressure by opening the blocked channel to allow fluid to flow.
The two-year Horizon study is the company’s largest trial to date for the device and the first with a global span. The study includes 556 patients and was conducted at 38 centers in nine countries.
Data from the trial found that patients with the device implanted reported greater reduction in intraocular pressure than patients who underwent cataract surgery alone, and with longer-term effect. The company also reported increased benefit over time.
Thomas Samuelson, global medical adviser for Ivantis and vice president of the American Society of Cataract and Refractive Surgeons, said the results strengthen the case for the use of Hydrus Microstent as the preferred approach for “patients with mild to moderate glaucoma undergoing cataract surgery.”
Outcomes exceed those of any Hydrus Microstent trial to date, the company said.
Ivantis raised $25 million in a series C in January.
Trial in Japan
Aerie Pharmaceuticals Inc. in Irvine will start a phase-two clinical trial in Japan for the potential submission of a netarsudil ophthalmic solution in the country. The drug, designed to treat patients with glaucoma, is known as Rhopressa in the U.S.
Aerie develops therapies for patients with glaucoma and other eye diseases.
The study will be conducted in the U.S., enrolling Japanese and Japanese-Americans. The company plans to conduct a phase-three trial in Japan.
“Our global expansion strategy is now in full execution mode for both Japan and Europe,” said Chief Executive Vicente Anido, adding that company executives believe there’s substantial unmet need in that market. “The Japanese glaucoma market is one of the largest in the world at approximately $1 billion annually.”
Aerie has two late-stage clinical drugs. The company said it anticipates approval of Rhopressa, its once-daily glaucoma eye drug to be approved in February. It said that in the first half of next year it will submit for FDA approval for its other drug, Roclatan, a once-daily eye drop that combines Rhopressa with latanoprost, a widely prescribed drug that treats elevated eye pressure.
Aerie has a phase-three trial in Europe for Roclatan.
Company stock currently trades at $61 per share for a $2.3 billion market cap.
Eating Right
Providence St. Joseph Health’s Southern California region, with 14 hospitals in Los Angeles, Orange and San Bernardino counties, expanded its Shop with Your Doc program to all three counties. The program, which involves placing a doctor or registered dietician in supermarkets, aims to help people make healthier decisions in their diets. It also provides shoppers free blood pressure checks. Partnering grocery stores include Ralphs and Food4Less.
The program is in its fourth year, and cardiologists have been added to help explain the importance of a nutritious diet in helping to prevent cardiovascular disease. It will focus on at-risk communities with higher-than-average rates of obesity, diabetes and heart disease.
Approximately 40% of adults and 20% of children in the U.S. are obese, according to the National Center for Health Statistics. In California about 25% of adults and 31% of children are overweight or obese.
The 50-hospital health system has locations in Alaska, California, Montana, New Mexico, Oregon, Texas and Washington and system offices in Renton, Wash., and Irvine. Its Southern California region has 14 hospitals, including St. Joseph Hoag Health in Irvine and Providence Health & Services in L.A. County.
