While the approval process for his insulin inhaler drags on, Alfred Mann this month received a welcome victory on another of his medical devices. The Food & Drug Administration signed off on limited use of a first-of-its-kind bionic eye for blind people.
The Argus II system by Second Sight Medical Products uses eyeglasses to communicate to implants in the eye. The glasses capture images and transmit them to the electrical implants. The implants communicate the images to the brain. It doesn’t completely restore sight, but can help patients regain some functional vision with black-and-white images.
The FDA’s initial approval, announced Feb. 14, enables Second Sight in Sylmar to market the $100,000 Argus to treat retinitis pigmentosa, a condition afflicting an estimated 100,000 people in the United States. The disease damages cells in the retina, causing blurred vision that eventually leads to blindness.
Dr. Robert Greenberg, Second Sight’s chief executive, said the Argus platform has the potential to treat a wide variety of eye ailments. While the Argus II received European approval more than a year ago, U.S. approval is especially sweet for Greenberg, who envisioned much of the underlying technology in the 1990s while working on his doctoral thesis at Johns Hopkins University in Baltimore.
“It still hasn’t set in yet that we finally made it,” Greenberg said. “This is a device that has received a lot of U.S. government money over the years, so to finally see it approved for use here is long overdue.”
Clinical trials now are planned on patients with macular degeneration, another disease that damages the retina and has become the leading cause of blindness in adults 60 and older. Down the road, the electrodes could be implanted in the back of the brain to treat blindness-related diabetes, glaucoma or physical injury where the eye itself is too damaged to benefit from an implant.
Greenberg formed Second Sight with Mann, who has a controlling interest in the business, soon after Greenberg left Johns Hopkins. Mann initially recruited him to run the Alfred Mann Foundation, which backs medical device research. When Mann approached him in 1998 about combining his research with Mann’s expertise in commercializing implant technology for pacemakers and insulin pumps, Greenberg said he jumped at the opportunity.
“Al has more than 30 years experience developing electrical devices that can safely survive for years inside the saline environment of a human body,” Greenberg said. “We spent years immersing versions of Argus in hot saltwater before we were confident.”
In addition to $100 million in government grants, Second Sight received another $100 million in private investment. The private money came from Mann, who is chairman of the company, and the Newport Beach office of Silicon Valley health care venture capital firm Versant Ventures.
Ahmed Enany, executive director of the Southern California Biomedical Council, said Second Sight could serve as another catalyst for the L.A. biotech industry if the company and its technology remain based here.
“They have competitors, but no one who is out of the R&D phase yet,” Enany said. “This is a company with an innovative technology platform which has the potential to become another medical device giant like Medtronic, if they stay the course and stay in Los Angeles.”
Afrezza Update
Mann’s public company in the diabetes space continues to address regulatory concerns about its experimental insulin inhaler.
MannKind Corp. executives said during the Valencia company’s fourth quarter conference call that they expect to submit a revised FDA application for the Afrezza inhaler in the third quarter.
The company, which initially filed for approval in 2009, had expected to receive FDA approval two years ago. But regulators balked at the company’s use of clinical trial data from an earlier model of the inhaler. They requested studies on the new model, which is smaller and according to the company even more effective than the previous model in delivering fast-acting insulin to diabetics to prevent blood sugar spikes after a meal.
The company finished recruiting patients for the clinical trials in November and hopes to have the studies completed this summer. If eventually approved next spring, Afrezza would be the only product of its kind on the market. Pfizer Inc. took its inhaler off the market in 2008 amid safety concerns.
MannKind has spent more than $2.13 billion since the company launched in 1991, and reported a net loss of $164 million last year. But Mann, who serves as chief executive of the company and has invested a significant amount of his personal fortune in it, continues to be upbeat about Afrezza’s prospects.
“I believe Afrezza will become a major weapon in the battle against the global diabetes pandemic,” he told analysts during a Feb. 11 conference call.
Staff reporter Deborah Crowe can be reached [email protected] or at (323) 549-5225, ext. 232.
