The World Health Organisation regards diabetes as a global epidemic. The current global population of diabetics is estimated at 400 million and is set to grow to 500 million by 2020. In the UK alone, there are currently 4 million diabetics and this is expected to grow to 5.5 million by 2020. Currently more than 280,000 people a year are diagnosed with diabetes.
 
One of the impacts of diabetes is diabetic retinopathy (DR), a disease caused by diabetes. DR is one of the most common causes of blindness in the western world. Most sight loss due to diabetes is preventable if treatment is given early. However, current treatments are prohibitively expensive, highly invasive and present a significant burden to patients and healthcare systems worldwide. Today in many countries, patients are not treated due to the prohibitive cost.
 
PolyPhotonix is providing an alternative to the present treatments for diabetic retinopathy. Using printed electronics, PolyPhotonix developed the Noctura 400, which consists of two OLEDs housed inside a softly cushioned fabric mask. Designed to be worn at night, the Noctura 400 delivers a precise dose of light therapy during a patient’s normal hours of sleep. At the end of the cycle (usually 12 weeks), the mask is returned for analysis and a replacement mask is provided. The collected data ensures patient compliance – a major issue for all health care providers.
 
PolyPhotonix CEO Richard Kirk noted that the Noctura 400 can solve the problems of diabetic retinopathy in a much less invasive and costly manner.
 
“Noctura offers an opportunity to provide eye treatment in a less invasive, less costly manner.,” Kirk said. “The Noctura treatment costs on average £1,000 ($1,300) per patient per year. This compares to £6,000  ($7,800) per year per eye with the pharmaceutical injection solution, which is highly invasive.
 
“Consequently, use of the injection is largely restricted to the western world, where health care providers and insurance systems are able to support the high cost,” he added. “However, even in these countries, there is a large unmet need as treatment is withheld until eyesight is threatened and compromised. The situation in developing countries is worse and many millions of patients are not able to afford treatment and will go blind without treatment.”
 
Kirk noted that the Noctura 400 is receiving excellent feedback from medical professionals.
 
“The Noctura 400 mask has completed a number of clinical trials and has CE certification with proven efficacy (class IIa),” Kirk reported. “The mask has over 1.2 million hours of recorded patient use and registration approval in a number of countries worldwide. There are International Key Opinion Leaders (KOLs) giving support in Europe, the US and increasingly in poorer countries such as India and China. We have two international Advisory Boards of KOLs, one in Europe and one in the US. We are currently developing an Advisory KOL Board in Asia.”
 
Kirk founded PolyPhotonix in 2008 as a joint venture with CPI. Originally an artist, Kirk found the idea of printed electronics to be interesting.
 
“I have no formal scientific training. Before becoming an entrepreneur and starting a research and science business, I was a professional artist, living and working in Paris for 15 years with some success,” he said. “On returning to the UK and moving to London, I was looking for new ideas and a new direction. It was during a lunchtime meeting in a Soho pub that I met someone who had a little interest in printed electronics. This was about 20 years ago.
 
“I became intrigued with the new technology, so much so that I embarked on a journey that culminated in the creation of a Bio-Photonic research company and a treatment for some of the most common causes of blindness in the western world,” added Kirk.
 
PolyPhotonix was initially a material science research and development company, but Kirk identified an early stage area of research that would tackle the root cause of diabetic retinopathy (DR) and diabetic macular edema (DME). Over the last five years, PolyPhotonix has raised approximately £19 million ($25 million) in peer-reviewed grant funding for clinical research and trials. Initially, much of this funding came from competitive research grants from the NHS, Innovate UK, SBRI Healthcare and HVM Catapult, and more recently from private equity.
 
Kirk noted that the retina uses more oxygen per unit mass than any other tissue in the body, due to the fact that photoreceptors have a phenomenally high metabolic rate. That demand for oxygen becomes even greater at night, rising by around 40 percent, as rod photoreceptors dark-adapt.
 
“Under normal physiologic circumstances, this isn’t a problem; the additional demand for oxygen is met by increased blood flow through the retinal vasculature. However, problems start to occur when that vasculature becomes damaged,” he said.
 
“A growing body of research has found that diseases such as diabetic retinopathy (DR) and diabetic macular edema (DME) are driven, at least in part, by retinal hypoxia,” Kirk observed. “People with diabetes commonly have microvascular damage, which can start to compromise retinal blood circulation. Once circulation is sufficiently compromised, the result is retinal hypoxia. This leads to upregulation of vascular endothelial growth factor – VEGF – with the consequence being retinal neovascularization. As those new vessels are leaky, the result is DME.”
 
Noctura 400 also presents very substantial cost savings to patients and healthcare providers. In the UK, a year’s Noctura 400 treatment is 17.5% of the cost of an average year’s treatment by intravitreal injections, potentially saving the UK’s National Health Service (NHS) in excess of £300 million  ($390 million) per year.
 
“Managing this growing patient population in a primary care environment, outside of hospital ophthalmic services, addresses a number of serious social and economic issues for the patient and the NHS. From an environmental perspective, it reduces the frequency of hospital visits, which also positively impacts the patient from both an economic and societal perspective. In 2010, indirect costs of partial sight and blindness in the UK is reported by RNIB to be £5.27 billion ($7 billion) per year, and globally the cost is reported to be $343 billion ($450 billion).”
 
With more than 1.2 million hours of recorded patient use, PolyPhotonix is moving forward to solve the problems of eye care for diabetics.
 
“There has been extensive market research and due diligence undertaken by third parties to measure patient demand and clinical acceptance. This has shown that there is a recognized need for a treatment that is effective at a much cheaper cost than current treatments. The size of the current global market for the most common pharmaceutical treatment is $6.5 billion and is expected to reach $11 billion by 2023,” Kirk said.
 
“Today, new eye clinics are being opened but the rate of growth in patient numbers means that the service is unable to cope with long-term demand and associated costs,” he continued. “Currently there is no discharge mechanism, so once a patient is under the care of ophthalmic services, they are a patient for life, with their individual costs of care increasing as their disease progresses.
 
“It is abroad where we focus the majority our commercial activity,” Kirk added. “Commercial sales are taking place in France, Belgium, Argentina, Brazil and Oman. A number of other countries are starting evaluations of the mask with patients, these include Hong Kong, India, Singapore, China, Korea and other countries. FDA approval in the US is in the process and is expected at the end of 2021. The mask has availability in the UK through optometry services and a number of key NHS hospitals.”