Victorian biotechnology company PolyActiva has received Federal Government funding of AU$100,000 to progress development of a sustained release ocular implant that will deliver steroids and nonsteroidal anti-inflammatory medications to the eye.
PolyActiva has also developed a bespoke device that enables the implant to be administered by clear corneal injection into the anterior chamber or trans-scleral injection into the vitreous chamber of the eye.
Dr Russell Tait, CEO of PolyActiva, told mivision, “The idea for the implant came in response to recognition that less than 50% of glaucoma patients fully comply with administration of drops within the first 12 months of starting their drop medication.
“There are two primary reasons for this: poor adherence – many patients simply forget to administer their drops, and poor drop competence – many patients simply cannot manage to put drops in their eye. Neither of these findings are a surprise when you realise glaucoma is a disease that primarily affects the elderly.
“Despite the reasons for poor compliance, the consequence is the same: a more rapid disease progression which left untreated will ultimately result in blindness. Consequently, there is a real need to provide a product that guarantees delivery of the daily medication without involvement of the patient. Implants as a form of dropless therapy meet that need.”
He said the challenges in developing the implant and administration device had been significant.
“We first had to build a system that was small enough to be administered through a 27 guage needle to the eye of a patient, yet carry sufficient drug (in our case latanoprost) to provide a constant daily dose for six months. Furthermore, the implant was required to rest in the inferior angle of the anterior chamber of the eye for the entire treatment period and not move, then biodegrade rapidly as soon as possible after the treatment period.
“We also had to develop a new process for the manufacture of the implants and a bespoke device to administer the implants. One of the significant challenges of the manufacture process was figuring out how to place an implant in the tip of a 27 guage needle without adversely affecting the needle. Once the implant was built with the desired characteristics, it had to be shown to be both safe and effective in non-clinical studies. This was achieved using the sole remaining glaucoma dog colony in the world. Only once all this was completed could we start our clinical program in human subjects,” said Dr Tait.
A six month report from a phase I human study still underway, has demonstrated that the implant is safe and generally well tolerated, and provides treatment for a six-month period before it biodegrades completely.
Dr Tait said the only real negative for a patient is the need for the implant to be administered by injection.
“It was for this reason we targeted a six month treatment period, to match a patient’s normal visitation cycle with their ophthalmologist, where the patient is already ‘prepped’ for injection. The extra procedure is then a simple 20 second injection at the slit-lamp, with the patient unable to see the needle and experiencing no pain or discomfort. We noted from our first clinical study that patients that had been administered the implant were keen to have it also administered in their non-study eye.”
He said government funding would allow PolyActiva to retain existing, and employ more, staff to work on development of the implant and progress its development faster than may have been achieved otherwise.