Brandon Capital-backed biotech start-up Azura Opthalmics has made a big leap towards creating the world’s first treatment for a type of dry eye disease, publishing promising phase two clinical trial results last week.
Most of the treatments available for dry eye, such as artificial teardrops, moisten the surface of the eye. But for 85 per cent of dry eye sufferers, the cause of the disease is actually a blockage (or some other type of abnormality) of the meibomian glands located in a person’s eyelid, resulting in the glands not secreting enough oil into the tears.
Azura, which was founded in Israel but now has an Australian CEO and does all of its clinical trial work in Australia, is developing a treatment for meibomian gland dysfunction.
The disease affects more than 30 million adults in the US alone, according to Azura CEO Marc Gleeson, and is one of the largest and most under served segments in ophthalmology.
“There’s a whole group of people out there that don’t realise there’s an underlying condition for their dry eye, and they’re using lubricants just to make their eyes comfortable,” he told The Australian Financial Review.
“This is an ointment. The glands reside behind the eyelashes and you take the ointment and put it on the glands itself. We’re taking a dermatological approach.”
The Phase 2A trial, which was designed to determine which segment of the patient population would get the most benefit from the treatment, showed that the ointment helped 59 per cent of patients in the highest dose group achieve a normal quality of fluid secretion from the meibomian gland after three months using the treatment.
On a lower dose, 46 per cent of patients achieved a normal quality, compared to 31 per cent of patients on a placebo. As well as this, 46 per cent of patients on the higher dose ointment achieved a statistically significant increase in the number of glands secreting fluid, compared to 8 per cent of patients on the placebo.
The ointment was also well tolerated, with no serious side effects. Thanks to the strong results, the company is now able to begin registration studies, which precede US Food and Drug Administration approval.
“The role of the program was to understand the strength of the signal and this gives us confidence moving into registration,” Mr Gleeson said. “In order to get the drug approved we need two registration studies … with 800 or so patients.”
Dry eye is one of the most common reasons a person goes to see an optometrist and as well as being uncomfortable, it can cause vision problems. Estimates for the number of Australians suffering from dry eye disease range from 20 per cent to 33 per cent of the population.
Meibomian gland dysfunction can occur naturally as a person ages, but can also be triggered or worsened by co-morbidities such as rheumatoid arthritis.
Azura was started in 2014 and Mr Gleeson was appointed CEO in 2016, after spending his career working in ophthalmology at biotech giants such as Allergan and Janssen.
Azura has raised $US38 million ($49.43 million) in capital, including a $US16 million round co-led by Melbourne-based Brandon Capital’s Medical Research Commercialisation Fund. It has also been backed by OrbiMed, TPG Biotech and Ganot Capital.
Like its phase two trial, that company’s registration studies will be conducted in Australia and New Zealand. Mr Gleeson is hopeful the company will make its application for approval to the US FDA within the next two to three years, depending on how long it takes to recruit the patients for the next trials.
As well as the meibomian gland dysfunction treatment, the company has a pipeline of other ophthalmology treatments in development, including for ocular manifestations of graft versus host disease, which can occur after someone has a transplant.
Mr Gleeson said Australia was the best place for ophthalmology companies to conduct research and development, thanks to a supportive regulatory environment and deep pools of local talent.
“Trials in Australia have high enrolment rates, in part because contract research organisations offer incentives for citizens to participate and the Australian government promotes clinical trials among consumers and health care providers, making it easy to get involved,” he said.
The Australian Financial Review
8 March, 2021