TheiaNova to test new, non-surgical treatment for keratoconus
CEO of medical start-up TheiaNova, Carissa Fonseca introduces the company’s ground-breaking treatment for the eye disorder keratoconus.
Keratoconus affects the cornea, the clear tissue that covers the front of your eye. It causes the collagen in the cornea to break down and prevents it from being replenished. Collagen keeps the structure of many of our tissues stable, and in the case of the cornea, it gives it shape, durability, and density. As the collagen degrades, the cornea thins, becoming distorted, irregular, and characteristically conical in shape. This leads to reduced and distorted vision, sensitivity to light, and if left untreated, in some extreme cases, the cornea can tear.
Traditionally thought of as a rare eye disease that only affects one in every 2000 people, we now believe keratoconus may be more common. A prominent ophthalmologist in the US claims one in every 870 people have the condition. Keratoconus may have been underreported in the past due to the lack of advanced diagnostic tools and may have also been under-diagnosed because symptoms are so similar to more common conditions like myopia.
Existing treatments for keratoconus
The first approach for people diagnosed with keratoconus is to treat their vision impairment using contact lenses or glasses.
Carissa explains what happens in cases where vision becomes more severely impaired. “One approach is a technique known as corneal crosslinking. This procedure involves peeling back the top layer of the cornea, inserting riboflavin drops and exposing the cornea to UV light. The UV light interacts with the riboflavin and causes the collagen in the cornea to become rigid. That rigidity prevents further thinning of the cornea. It is quite effective, although in some cases, repeat procedures have been required. However, for severe cases where the cornea is thin to the point of tearing, the only solution is a corneal transplant.”
TheiaNova’s novel approach to keratoconus
The keratoconus treatment TheiaNova has discovered is far less invasive than surgical methods, using simple eye drops to strengthen the cornea.
PhD student Carol Greene was working in the Department of Ophthalmology at Waipapa Taumata Rau, University of Auckland researching corneal cells known as keratocytes, with Professors Colin Green and Trevor Sherwin, and Associate Professor Ilva Rupenthal. She discovered keratocytes could be reprogrammed to produce a type of collagen normally only expressed in the embryonic stage of development. The University team realised if they could apply this discovery to patients with keratoconus, maybe they could strengthen their corneas.
They tested their hypothesis in cell cultures and in animal studies and found that not only could they strengthen the cornea, but the collagen was laid down in the same pattern naturally occurring in the cornea. So, their next hypothesis was maybe this treatment can strengthen the structure of the cornea in humans and prevent further deterioration from keratoconus.
“The team realised they had something with potential commercial value when they saw they could reprogram keratocytes to produce collagen. At that point they started conversations with UniServices, the research application and commercialisation company of the University. UniServices supported the team with their initial due diligence and helped secure the IP. Once those early experiments confirmed their initial hypothesis, investors were approached. That’s when Bridgewest entered the picture with funding to launch our first human study.”
Coming full circle
Carissa joined TheiaNova as CEO at the start of September 2022. She says, “My first real taste of scientific research was a summer internship in the lab of Colin Green over 20 years ago. He is part of the University team that invented the TheiaNova treatment, except neither he nor I imagined this at the time. He became my mentor, but my scientific interests back then were in medical imaging, very different to the type of work Colin was doing.”
“I went on to do a PhD in MRI and a postdoc in medical imaging at UCLA, followed by working at GE Healthcare. After 11 years in the States, I returned to New Zealand, and worked at Fisher & Paykel Healthcare in a medical affairs clinical research role. After a while, I decided to broaden my scope and started my own consultancy helping medical start-ups develop clinical relationships and understand the regulatory environment.”
“My career gave me a good sense of the multi-faceted demands of developing medical products from R&D to clinical trials, marketing, medical education, and regulatory requirements. I’ve also enjoyed working alongside the medical community to help develop products fit for purpose. So, when Colin got in touch and said he’d secured funding for a new treatment he was hoping to commercialise and would I come on board to help launch the business, it was a no-brainer to say yes! I’m delighted to have this opportunity to work with him again.”
A game changer for patients with keratoconus
Carissa outlines her team’s next steps. “The pathway to regulatory clearance for any drug is long. Our next step is a small-scale study. If that is successful we’ll enter the pathway for regulatory approval. That can take five to ten years. One reason it takes so long is because later phases of clinical research require large numbers of patients. To recruit those patients, especially for a disease that’s hard to diagnose like keratoconus, can take quite some time.”
“However, we’re working to a very ambitious timeline. We want to do this as quickly as we can because this potential treatment for keratoconus could be a game changer for patients.”
“Keratoconus tends to present in puberty. It often stabilises in later life. But if you think of the impact on the patients, they're in the prime of life and their vision is slowly deteriorating. At best it's a pain, at worst it can have serious consequences, especially if they’re on the pathway to surgery. So, we want to get this treatment into the hands of physicians as soon as possible.”
“With younger keratoconus patients often facing repeat surgical interventions through life, we aim to not only slow disease progression, but to rebuild the thinning cornea whilst improving vision. We’ve been contacted by many keratoconus patients and for them there remains an unmet need we really hope we can satisfy.”
Future investment opportunities
After their proof of concept trial, TheiaNova will be looking for investment to take their treatment through regulatory clearance. Colin Green has a few words for potential future investors.
“This is a ground-breaking approach to keratoconus, based upon sound, well established science, with well protected IP. The treatment has been shown to work in human tissues and has potential to translate readily and safely to the clinic. With TheiaNova’s completion of a human proof of concept trial, risk will be wrung from an attractive investment which for keratoconus alone provides a significant market opportunity.”
“In the future, this treatment may transfer to patients with myopia, correcting vision defects without surgery. In some Asian countries over 80% of the population suffer from myopia, so the potential to help so many people worldwide, whether suffering from keratoconus or myopia, becomes extremely motivating. If the treatment crosses into the myopia market as expected, the opportunity is very large.”
A vote of confidence in New Zealand medical innovation
TheiaNova chose Bridgewest as their investment partner because of the support we offer start-ups. Carissa says, “Bridgewest operates like an incubator for their portfolio of companies with wraparound support for inventors and founders of start-ups in all aspects of business development, as well as a vast network of experts for us to tap into around the world. They have experts in clinical circles, in drug development, and in regulatory approval, and that’s just the medical sector. I’ve seen first-hand how beneficial their network can be.”
“Having international companies like Bridgewest connect our brilliant scientists to the rest of the world is not only a vote of confidence in the work they’re doing, but it also puts them on the global stage. And this investment demonstrates to researchers yet to commercialise their ideas solid pathways to take ideas to market.”
“Bridgewest’s investments in medical start-ups like TheiaNova are important because medical innovation in New Zealand has lagged behind. But New Zealand is not new to medical research, whether it be international pharma companies doing clinical trials here, or the world-renowned experts in our universities. We can make a difference to the lives of people living all around the world.”
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