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PolyActiva Commences Its First Phase I Clinical Trial with Potential to Improve Daily Lives of Millions of Glaucoma Patients

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Innovative treatment for second most common cause of irreversible
blindness goes to clinical trials supported by USD$12m investment from
two Australian venture capital firms

PolyActiva Pty Ltd, a clinical-stage Australian biotechnology company,
has recently recruited first patients into its Phase I clinical study
designed to show its glaucoma implant is safe and well tolerated.

PolyActiva has used its proprietary polymer prodrug technology to
develop ocular implants that, when placed in the eye, provide sustained
treatment over a six-month period, compared to current glaucoma
treatment where patients often need to administer four eye drops daily.
The revolutionary technology could in the future mean millions of people
with open-angle glaucoma no longer need to use daily eye drops.

The potential of removing the reliance on the patient to remember to use
eye drops, and the associated difficulty in administering them from the
paradigm of glaucoma treatment, is being heralded as major potential
health breakthrough by ophthalmologists. Several studies have
demonstrated that up to 46 percent of patients have been found not to
remember to use their drops or administer them poorly1.
Failure to adhere to treatment can lead to faster progression of
glaucoma, one of the most common causes of blindness.

"This product is designed to make the lives of glaucoma sufferers easier
by removing the need for daily drop administration and thus improving
treatment management," says PolyActiva CEO Dr Russell Tait. "The implant
is designed to deliver treatment for six months after which it will
disappear without further intervention. We're excited about starting our
first clinical study and look forward to seeing how our lead candidate
performs."

Glaucoma is the second leading cause of irreversible blindness globally,
affecting 2.7 million Americans, and is expected to affect approximately
80 million people worldwide by 2020. In the US, more than 120,000 people
are blind from glaucoma, accounting for 9 to 12 percent of all cases of
blindness. The global glaucoma market is estimated to be valued at over
USD$1 billion.

"The major investors, MRCF and Yuuwa Capital, see this technology having
a major potential impact on the lives of millions of glaucoma patients
globally," says Dr Chris Nave, Chairman of PolyActiva and CEO of the
Medical Research Commercialisation Fund (MRCF). "This innovative drug
delivery technology has further potential applications, such as being
used to administer other types of medication, including antibiotics and
steroids for cataract surgery patients."

PolyActiva's first clinical candidate is designed to provide a constant
daily therapeutic dose of latanoprost free acid for at least 26 weeks,
which is the active ingredient of a commonly prescribed glaucoma
eye-drop (Xalatan®).

The clinical trial will assess the safety and tolerance of the implant
when administered to glaucoma patients. The implant is also designed to
biodegrade within 90 days after the treatment period and is capable of
being administered in an ophthalmologist's office under a slit-lamp
using a custom-designed administration device.

One of the lead investigators, renowned ophthalmologist and cataract
surgeon, Dr Nathan Kerr says, "PolyActiva's treatment approach offers
significant potential benefits for patients, addressing adherence and
improving treatment of this disease. The bespoke administration device
is simple to use and intuitive to operate."

The Phase I clinical trial is being conducted under the Therapeutic
Goods Administration Clinical Trial Notification (CTN) scheme at the
Royal Victorian Eye and Ear Hospital in Melbourne, Australia, through
the Centre of Eye Research Australia (CERA). The Phase I clinical trial
will see seven glaucoma patients enrolled to evaluate the safety and
tolerability of its PA5108 ocular implant, with initial results expected
in Q1 2019.

PolyActiva has secured investment funds to date of USD$12m from
Australian-based venture capital firms Brandon Capital and Yuuwa Capital.

Further details of the study design can be found on www.anzctr.org.au
or www.clinicaltrials.gov.

1 Laura E. Dreer, Christopher Girkin and Steven L.
Mansberger. Determinants of Medication Adherence to Topical Glaucoma
Therapy. J Glaucoma. 2012 Apr; 21(4): 234–240.

About the Medical Research Commercialisation Fund (MRCF) and Brandon
Capital Partners

Brandon Capital Partners is a venture capital firm that manages the
Medical Research Commercialisation Fund (MRCF), Australia and New
Zealand's largest life science investment fund.

www.brandoncapital.com.au

About Yuuwa Capital LP

Yuuwa Capital is a $40M early-stage venture capital firm based in Perth,
Western Australia.

www.yuuwa.com.au

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