Posts

Australian tech could end need for daily eye drops

Australian tech could end need for daily eye drops

A clinical-stage Australian biotechnology company, PolyActiva, has recruited patients into its Phase I clinical trial for a new ocular implant that could improve the daily lives of millions of glaucoma patients.

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 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 300,000 Australians and is expected to affect approximately 80 million people worldwide by 2020. Increased intraocular pressure (IOP) in the major risk factor for the optic nerve damage that results in blindness. Treatment is designed to reduce IOP. Eye drop therapy is the mainstay of glaucoma treatment however there are two main deficiencies associated with drop therapy – poor patient adherence resulting from the need to administer drops daily and local side-effects resulting from the topical administration of the drug to the eye. Alternative methods of delivering drugs to the eye are required to increase patient adherence to treatment.

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.

 

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.

 

Article appeared on Glaucoma Australia 

glaucoma

Aussie Tech Could End Glaucoma Eye Drops

Australian tech could end glaucoma eye drops

A clinical-stage Australian biotechnology company has begun recruiting glaucoma patients for a trial of a new implant that could end the need for daily eye drops.

PolyActiva has developed ocular implants that, when placed in the eye, provide sustained treatment over a six-month period, potentially removing the need for patients to manage their own treatment. Such a move could improve glaucoma outcomes, as several studies have demonstrated that up to 46% of patients don’t remember to use their drops or administer them poorly.

PolyActiva CEO Dr Russell Tait told Insight the technology had originally been developed for a different purpose, but its ability to carry a large amount of drugs in a small area and achieve zero order release, while maintaining separate control over the implant’s biodegradation made it ideal for delivering drugs to the eye.

“The implant is designed to deliver treatment for six months after which it will disappear without further intervention.”
Russell Tait, PolyActiva

“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,” Tait said.

“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.”

According to Tait, the implant is capable of being administered in an ophthalmologist’s office under a slit-lamp using a custom-designed administration device.

“The implant itself is tiny – it’s about .2 mm in diameter and up to 4 mm in length, depending on the strength of the relevant product,” he explained.

“It sits in the lumen of a 27 gauge needle and it’s administered by clear corneal injection with a custom-built administration. For the glaucoma product it sits in the inferior angle of the interior chamber.”

The clinical trial will assess the safety and tolerance of the implant when administered to glaucoma patients and should be completed by the middle of 2019, with a view to eventually bringing the technology to market in around six years. Trials will initially be restricted to Australia, however as they progress Tait said the company would look to engage centres in the US as well.

“The major investors, MRCF [Medical Research Commercialisation Fund] and Yuuwa Capital, see this technology having a major potential impact on the lives of millions of glaucoma patients globally,” Dr Chris Nave, chairman of PolyActiva and CEO of the MRCF said.

“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. Latanoprost is the active ingredient of a commonly prescribed glaucoma eye-drop treatment (Xalatan).

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, through the Centre of Eye Research Australia (CERA).

Article appeared on Insight

05/09/2018 • By Matthew Woodley

contact lens

A Warning for Contact Lens Wearers

Warning for contact lens wearers as infection increases

Blinding Acanthamoeba keratitis infections are on the rise, according to a new study led by UNSW’s Dr Nicole Carnt.

The research, which was conducted at Moorfields Eye Hospital in the UK while Carnt was on an NHMRC CJ Martin Biomedical Early Career Fellowship, found a threefold increase in Acanthamoebakeratitis infections in Southeast England since 2011. However, while the study is based on data from the UK, Carnt said its findings were equally important in Australia.

“It is absolutely imperative that regulators and those working in the optical sector take the findings seriously, and use the recommendations to take immediate and urgent action on prevention,” Carnt said.

“Contact lenses are medical devices and should be supplied with warnings regarding safe use.”

“It is absolutely imperative that regulators and those working in the optical sector take the findings seriously.”
Nicole Carnt, UNSW

Carnt told Insight she has been working with the Cornea and Contact Lens Society Australia (CCLSA) to develop a website dedicated to healthy contact lens wear, along with other initiatives to raise awareness.

“We are trying to encourage optometrists to talk about water related risks, as often they tend to skip over it as in the too hard basket or the risk too low to enforce the message,” she said.

“Yes, contact lenses are a lifestyle option and we don’t want people to be restricted but we do want them to be aware of the risks and take precautions where needed. Our message is to choose healthy contact lens wear.”

While the infection is quite rare, usually affecting 2.5 in 100,000 contact lens users per year, one in four people affected will need a corneal transplant to treat the disease and restore vision.

A member of the Acanthamoeba Keratitis Patient Support Group in the UK led by Carnt, Ms Irenie Ekkeshis, says more needs to be done to prevent new cases.

“This research confirms what those of us affected by Acanthamoeba keratitis have suspected for some time: that incidences of this awful, life-changing infection are on the increase,” Ekkeshis said.

“There’s more that should be done to prevent people from losing their sight to Acanthamoeba keratitis.”

The microorganism responsible for the infection can often be found in bodies of water such as lakes, oceans and rivers, as well as domestic tap water, swimming pools, hot tubs, soil and air. As such, Carnt said contact lens wearers needed to be aware of the risks associated with use around water.

Acanthamoeba keratitis is a largely preventable disease. People who wear reusable contact lenses need to make sure they thoroughly wash and dry their hands before handling contact lenses, and avoid wearing them while swimming, face washing or bathing,” she said.

“Daily disposable lenses, which eliminate the need for contact lens cases or solutions, may be safer and we are currently analysing our data to establish the risk factors for these.”

The study was published in the British Journal of Ophthalmology.

Article appeared on Insight

26/09/2018 • By Matthew Woodley

 

Discuss your family’s eye history this JulEYE.

It’s as simple as having a conversation and as serious as saving your eyesight.

The RANZCO Eye Foundation (Royal Australian & New Zealand College of Ophthalmologists), a national not-for-profit organization, dedicates the month of July to its annual community awareness campaign.  JulEYE is aimed at educating Australians about eye disease and this year is encouraging everyone to discuss their family eye history. Despite 75% of vision loss being preventable or treatable, many Australians are still not finding out if eye disease is part of their family history to determine if they’re at risk and need to have their eyes checked.

juleye

RANZCO Fellow, Professor Frank Martin AM says: “To ensure we preserve our eyesight, Australians need to be more aware of their family’s eye history. If you have a family history of eye disease, a medical condition that can have eye related issues such as diabetes or are over the age of 40, eye testing every two years is essential as it is the most effective way to identify problems early. So this July, find out about your family’s eye health history.”

CEO of The RANZCO Eye Foundation, Jacinta Spurrett explains the JulEYE campaign, now in its sixth year, continues to educate Australians about eye disease.

“Too many young people equate vision loss or blindness to old age, but eye disease, like cancer, is indiscriminate and can happen at any age. More than 200,000 Australians are currently suffering from vision loss related to eye disease and every year a further 10,000 Australians will lose part of their vision or go blind. It is very important that you find out if you have a history of eye disease in the family and if necessary, be referred to an Ophthalmologist to have your eyes tested this July,” Spurrett adds.

“Each year we aim to reach more and more Australians with our message. Our focus in the first week of JulEYE is to encourage Australians to discuss their family’s eye history and to get their eyes tested if there is a history of eye disease. We will also highlight the real and increasing rate of diabetic retinopathy. With over 1.1 million Australians currently diagnosed with either Type 1 or Type 2 diabetes , it is vital that eye health check-ups are part of their overall diabetes management. Throughout JulEYE we will continue to challenge Australians to start talking about their family’s eye health and make it part of their family health discussions,” Jacinta Spurrett said.

Joining the JulEYE call to action is INXS band member and ‘JulEYE’ Ambassador, Kirk Pengilly; renowned Australian legal academic and 2011 Senior Australian of Year, Professor Ron McCallum AO, who has been totally blind since birth; former Director of the National Gallery of Australia, Betty Churcher AO who suffers from macular degeneration; and one of Australia’s highest-selling independent musical artists and motivational speakers, Lorin Nicholson who is also legally blind.

No one should take his or her eyesight for granted.

An eye test can detect the main causes of vision loss such as glaucoma, macular degeneration, diabetic retinopathy and cataracts. Eye disease is not just an affliction of the elderly – many of these diseases are hereditary and can cause blindness in babies, teenagers and adults alike. To find out where you can be tested, or to donate to The RANZCO Eye Foundation and support eye health research and sustainable development projects, visit www.eyefoundation.org.au or to join the conversation, go to: http://www.facebook.com/EyeFoundation