Two tiny wireless devices, being tested for their ability to stimulate natural tear production in patients with dry eye, have been welcomed with caution by Australian eye health specialists.
The devices have been designed to deliver micro-electrical pulses to the lacrimal gland. One model is inserted into the mucous membrane in the nasal cavity, and the other is inserted under the skin below the eyebrow. Tear delivery rates can be adjusted manually with a wireless controller.
The devices were conceived by Dr. Michael Ackermann, while a fellow at a training program in medical-technology innovation and development at Stanford Biodesign in the United States. Each year, Stanford Biodesign admits 12 applicants with backgrounds in medicine, engineering and business. These Biodesign fellows work to address unmet medical needs through the development of new technologies
and devices.
Dr. Ackerman said early in the program, while reviewing the field of ophthalmology, he recognised dry eye as a promising area in which to work. “Every third person visiting the clinic seemed to be suffering from dry eye, which ranged from something that was a nuisance to a genuine, sight-threatening disease,” he said. “It was a huge medical need with no optimal treatments.”
Dry eye can be triggered by a number of factors, including gland defects, medication side effects and hormonal changes caused by pregnancy or menopause. It is also associated with some immune-system disorders. Dry eyes become vulnerable to painful abrasions of the cornea, which can distort vision.
The two most common dry-eye treatments are lubricating eyedrops and cyclosporine, a topical emulsion, however eyedrops require refrigeration, making them difficult to apply when needed, and don’t replicate all the vital components of natural tears. The topical ointment treats the inflammation associated with dry eye but not the root cause of the condition.
In his second year as a fellow at Stanford Biodesign, and following the successful development of a prototype, Dr. Ackermann launched a company, called Oculeve, to develop the tear-stimulation devices and bring them to market. It was seed funded with US$100,000 by Silicon Valley venture-capital firm Kleiner Perkins Caufield and Byers. “Oculeve was after a large market with weak competition,” said Byers. “They had a clever new invention, a good economic model and a strong starting team.”
The funding enabled Oculeve to test a prototype for efficacy and safety in animals. In October 2012, after proof-of-concept testing, Byers and Ackermann raised a further $7.6 million from a group of health-care venture capitalists which was used to hire employees and launch clinical trials in Australia, New Zealand and Mexico.
In May 2014, Oculeve investors contributed an additional $16.6 million to the company which, Dr. Ackermann hoped, would fund the process of getting a medical device through its European and Canadian round of regulatory approvals. A study to assess the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator for the treatment of dry eye disease started in December 2014 and was due for completion this month (March 2015).
Sydney optometrist Dr. Jim Kokkinakis said while the device “sounds perfect for dry eye… I do not think it will be the panacea we are looking for”.
“Most dry eye is oil deficiency. This device only creates more water,” said Mr. Kokkinakis. “The other problem I have is that by continually stimulating the lacrimal gland, will we cause it to inflame and possibly atrophy? Maybe in the long term we could make the problem worse. Time will tell.”
Conjoint Associate Professor Colin Chan, from University of Sydney, also expressed reservations about the potential of the implant. “I see many dry eye patients, so I am grateful whenever new treatments emerge. The approach of the Oculeve implanted device is certainly novel and would benefit in particular patients who
had neutrophic corneas such as post herpes simplex or herpes zoster ophthalmicus,” he said.
“I have a few reservations about this device and approach. These are: 1. The risk of rejection or infection of the surgically implanted device; 2. The quality and nature of tears produced by intermittent electrical stimulation as we all know reflex tearing is different from basal aqueous secretion;
3. It does not directly address the most common cause of dry eye which is meibomian gland dysfunction.
“However, I look forward to the results of the clinical trial,” he added.
