- TheiaNova is developing a world-first keratoconus treatment that regenerates collagen in the eyes by combining human growth factor TGF-B3 and low-dose steroid dexamethasone applied as an eye drop over three weeks.
- TheiaNova seeks USD$10m in investment for next phase of clinical development.
- CEO Carissa Fonseca will present as a finalist at renowned Eyecelerator ophthalmology pitch competition, adjacent to the American Society of Cataract and Refractive Surgery annual meeting, - one of just three companies selected to present.
TheiaNova, a New Zealand-based ophthalmology company developing a novel approach to treating keratoconus with a patented eye-drop solution, has delivered the company’s pitch as a finalist in the renowned Eyecelerator event in Boston today.
Today at the Eyecelerator event, where TheiaNova participated as a finalist, CEO Carissa Fonseca announced the company’s efforts to raise USD$10m for the company’s Phase I and II clinical trials, following data from their proof-of-concept study in New Zealand anticipated later this year.
“There are millions of people in the world living with keratoconus, an incurable condition which can lead to blindness. Our vision is that this treatment will give people living with keratoconus hope by providing a non-invasive, simple eye-drop solution to what has traditionally been a difficult-to-treat disease,” Fonseca says.
TheiaNova is developing a painless, and non-invasive, treatment requiring the patient to take two doses of eye drops daily for a three-week period, in which time the treatment is expected to regenerate lost collagen in the eye, restoring the cornea’s rigidity.
Keratoconus is a debilitating, rare and incurable disease which impacts patients in the prime of their lives by breaking down the cornea’s collagen matrix, resulting in a progressively thinner, weaker, and chronically bulging cornea disrupting normal light refraction.
Currently, treatment for keratoconus is limited to an invasive, painful surgical procedure known as cross-linking to increase collagen links in a patient’s cornea and therefore stiffen it. However, the procedure often cannot generate results for patients where significant collagen loss has already occurred.
Globally esteemed scientist Professor Colin Green, who has in the past co-founded five biotechnology companies and is an inventor on over 465 patents in 24 patent classes, led the group which spearheaded the development of the treatment at the University of Auckland in New Zealand.
“TheiaNova’s unique approach rebuilds the cornea rather than simply attempting to retain already reduced collagen levels. It combines a human growth factor with a low dose of a steroid already approved for ocular use to trigger developmental pathways which induce cells in the cornea to temporarily change their behavior and secrete new collagen,” says Professor Green.
“This is a world first approach to rebuild the cornea’s structural integrity and to halt disease progression, whilst providing an innovative opportunity to correct lost vision in a predictable manner” continues Professor Green.
Fonseca said the combination of these two compounds in animal trials has been found to regenerate collagen and restore corneal rigidity.
“We’re exploring how our treatment could be used beyond keratoconus treatment, including post-refractive surgery ectasia, and other similar corneal disorders which also have serious impact on patients,” says Fonseca.
With seed funding from Bridgewest Ventures New Zealand, Auckland UniServices and Callaghan Innovation’s technology incubator programme, TheiaNova have made leaps and bounds.
However further funding, approximately $10m USD, is needed to bring the treatment to the next stage of development, enabling the company to finetune their clinical strategy in alignment with regulatory bodies, and to design and conduct Phase I & II clinical trials over the next couple of years.
“The global addressable market for this condition is remarkable,” said Fonseca. “We’re looking at a USD$2-3b addressable market, and a USD$1b serviceable market – meaning this is a great opportunity for investors to back a scalable treatment with the potential to change the lives of millions of patients worldwide.”
Capital raised would also go towards protecting new IP and defining TheiaNova’s reimbursement and market access strategies. The company already holds patents in multiple markets, including the United States, Australia, and New Zealand.
The global prevalence of keratoconus has been reported to be 1.40 per 1000 population. This varies across countries though and prevalence is significantly higher in indigenous communities in the Asia Pacific, with India having the highest prevalence rate overall.
In some countries like Australia, one in 85 patients will be diagnosed and in Germany, for example, the incidence is now thought to be ten times higher than previously reported.