Ivantis in Irvine received approval to begin a clinical trial “summit” for the Hydrus Microstent, a device designed to lower eye pressure in glaucoma patients. The trial will assess safety and effectiveness of the device in 60 advanced glaucoma patients over a 12-month period.
Chief Executive Dave Van Meter said the trial will allow the implant to be “evaluated in a full range of mild to advanced glaucoma, representative of the approximately 5 million” U.S. patients with the disease.
Ivantis previously conducted studies of the device in early-stage, mild-to-moderate glaucoma patients, including a randomized, controlled trial in Europe and the U.S. for patients undergoing cataract surgery.
The device, roughly the size of an eyelash, is designed to reduce eye pressure by opening a bypass through blockage to allow eye fluid outflow. Most types of glaucoma compromise the eye’s drainage system, preventing intraocular fluid from draining and leading to optic nerve damage and vision loss.
Ivantis is a privately held company established in 2007 that develops products for eye diseases. The company closed a $25 million series C financing this year in support of the clinical trials. RA Capital Management in Boston, which is among its investors, led the round. Other investors include New Enterprise Associates, Delphi Ventures, Foresite Capital and Acension Ventures.
Stem Cell Trial
Cell therapy company jCyte Inc. in Newport Beach officially launched a follow-on phase two clinical trial of its stem cell-based treatment for retinitis pigmentosa, a rare, inherited degenerative eye disease that causes vision loss and eventual blindness. The company will start recruiting this month, targeting 70 patients.
Co-founder Henry Klassen said there is currently no effective treatment for retinitis pigmentosa and that many patients suffering from the disease are legally blind by the time they reach 40.
The nonsurgical treatment involves injecting retinal progenitors cells into the eye, with the goal of rescuing diseased retinal cells and possibly generating new ones.
The multicenter trial, which is being funded through an $8.3 million matching grant from the California Institute of Regenerative Medicine, will evaluate visual function based on visual acuity, visual fields, contrast sensitivity and mobility skills over the course of a year.
System OK’d
Edwards Lifesciences Corp. received Federal Drug Administration clearance for its HemoSphere advanced monitoring system. The device monitors hemodynamics, measuring blood flow and pressure inside veins, the heart and arteries to allow doctors to evaluate whether enough oxygen is being delivered to organs and tissues.
HemoSphere is wireless-enabled but currently compatible only with the device maker’s pulmonary artery and oximetry catheters.
The monitoring system is also available in Europe, Japan, Australia and New Zealand.
Irvine-based Edwards makes devices for structural heart disease, as well as critical care and surgical monitoring. It has about a $23 billion market cap. Critical-care business makes up 19% of Edwards’ total sales, according to its 2016 annual report.
UCI Research
University of California-Irvine, as Orange County’s only academic health system, focuses research endeavors in aging-associated diseases, including diseases related to memory loss and movement difficulty. Two doctor-professors: Neal Hermanowicz, director of the movement disorders program at UCI Health and vice chair and professor of clinical affairs at the department of neurology, and Nicolas Phielipp, shared the latest research and treatment of patients with Parkinson’s disease, dystonia, or involuntary twitching, and Huntington’s disease, at Newport Beach Public Library last week.
The event was part of the Newport Beach Public Library Foundation’s “Medicine in Our Backyard” talk series. The foundation has three full-time employees and 25 volunteers. It provides approximately $876,000 to the library and its programs.
Allergan Presentation
Allergan PLC presented findings at the 69th American Academy of Neurology annual meeting in Boston. Highlights include presentations on chronic migraine and post-stroke spasticity, or involuntary muscle contractions, which belong to the pharmaceutical company’s Irvine campus.
Allergan’s flagship Botox, in addition to smoothing wrinkles, is approved for several medical conditions, including chronic migraine and various types of dystonia, or muscle spasms.
Allergan is chartered in Dublin, Ireland, and maintains U.S. headquarters in Parsippany, N.J., and a campus in Irvine.
Bits & Pieces
Toshiba America Medical Systems Inc., a Canon Group company headquartered in Tustin, named Dan Skyba director of its ultrasound business unit responsible for marketing strategies. Skyba previously served as global director of product marketing and education for SuperSonic Imagine. Toshiba America Medical makes and sells radiology and cardiovascular equipment. … The Samueli Center for Integrative Medicine and the UCI health system hosted the 15th Women’s Wellness Day last week at the Irvine Marriott. Integrative medicine focuses on treatment alternatives, such as acupuncture, herbal medicine, biofeedback and yoga. Keynote speaker was Chez Panisse chef Alice Waters.
