Melbourne biotech company muPharma, founded by ophthalmologist Dr Harry Unger and Mr Mark Unger, has developed an investigational device that uses ultrasound to deliver therapies non-invasively through ocular tissues, offering potential advantages over the standard of care for some retinal and corneal diseases.
The handheld system comprises a reusable ultrasound actuator and a disposable, sterile tip. The tip features a solid, non-reactive substrate with fabricated features to hold the relevant drug. The mechanism of action, called sonophoresis, involves gentle ultrasonic vibration causing cavitation in tissue – this “opens” the inter-cellular spaces and makes cell surface membranes more permeable.
This technology has also been shown to have applications in immunology, delivering vaccines to the inside of the lip.
In ophthalmology, the muPharma device could replace intravitreal injections for age-related macular degeneration (AMD) and avoid removal of the corneal-epithelium for corneal cross-linking treatment.
muPharma managing director Mark Unger, who is an Adjunct Senior Research Fellow at the Monash Institute of Pharmaceutical Sciences and an Honorary Fellow at The University of Melbourne Department of Ophthalmology, said overcoming the need for eye injections could alleviate patient fear, a predominant cause of non-compliance.
“Our device also removes the significant risks associated with injections into the eye, including raising intraocular pressure as only the drug – and not the solution – in which it is dissolved, is delivered which is not only advantageous for wet-form AMD, but also opens new dry-form AMD treatment options,” he said.
“muPharma’s device provides convenience for patients who could potentially drive and work shortly after treatment and not need carers unless otherwise required because of general debility. There is also potential for increased ophthalmologist productivity to perform more complex and profitable procedures through having supervised para-medical staff provide treatment.”
Given its route of delivery, Mark Unger said there is also the possibility of needing lower anti-VEGF doses.
For corneal cross-linking, the muPharma device offers an “epi-on” method of rapidly, safely and effectively delivering riboflavin into the cornea without the need to remove the corneal epithelium.
“Riboflavin formulations delivered by the muPharma device do not require any epithelial enhancers and the cross-linking procedure can be done in keeping with well-established and approved FDA clinical protocols that have demonstrated clinical efficacy,” he said.
The muPharma concept was developed by Dr Harry Unger, building on a previous, but ultimately limited, ultrasound-based system he conceived using a polymer gel to hold and release drugs.
During the past decade, the muPharma device has been developed at the Melbourne Centre for Nanofabrication under Professor Nicolas Voelcker (scientific director at MCN). Dr Harry Unger is chairman, guiding the company’s research direction in ophthalmology, and Dr Glenn Begley, previously the CEO of BioCurate and vice-president of Oncology Global Research at Amgen, is the medical director.
Although using ultrasound to deliver drugs into skin is well established, Mark Unger said muPharma’s technology for ocular and mucosal membrane delivery “is highly novel” with various granted patents globally. Extensive histology and functional analysis has shown the technology does not damage any ocular tissue.
“The device has also been used in a small number of human subjects (with ethics approval) and was well tolerated and without adverse sequelae. Follow-on human trials for ocular biologics and riboflavin are being planned.”
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