What is geographic atrophy?

Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD). 1 2 

AMD is a disease that occurs in those above 50 years of age 3 that causes the gradual and permanent loss of sight due to blurring or loss of central vision which affects the ability to read and see faces. 

There are different stages of AMD. These are categorised using the Beckmann classification 4 based on the clinical examination or evaluation of a fundus photo, which is a photo taken of the rear of the eye to identify lesions.

AMD has 3 distinct stages, early, intermediate, and advanced. 5 The early and intermediate stages of AMD are less likely to cause changes in the vision. There are two forms of advanced AMD. 6

1. Geographic atrophy (GA) (‘dry’ AMD) occurs when the photoreceptors and retinal pigment epithelium (RPE) cells at the macula die over time, causing a gradual, painless but permanent loss of central vision. The macula is the central part of the retina that processes what you see directly in front of you, that is, your central vision. It allows you to achieve high-resolution vision and accounts for your ability to read, recognise faces and to see the world in detail and colour.

  • GA is a progressive disease that leads to irreversible central blindness over time. 7 The severity of the visual disability associated with GA secondary to AMD is evidenced by the median time to progression to legal blindness estimated at 6.2 years. 8

2. Neovascular AMD (‘wet’ AMD) occurs where new blood vessels grow into and under the retina, which can leak and cause bleeds leading to sudden vision loss and distorted vision.

How many people live with GA?

It is estimated that there are up to 100,000 Australians living with GA. This is based on an average 1-2% population estimate of late-stage AMD and that GA appears to occur in a proportion equal to that of those with wet or neovascular AMD. 9 10 11 12

Worldwide, there are an estimated 5 million people living with GA. 13

  • The incidence of GA is also more prevalent in the European population compared to the Asian, African, and Hispanic populations. 14 15
  • The incidence of GA has been shown to increase four-fold every ten years from the ages 50 to 80 in the European population. 16 17
  • As the aging population globally is estimated to increase over the coming decades, and the incidence of GA is therefore also projected to rise. 18
Source image: Courtesy of Macular Research Unit, Centre for Eye Research Australia

How is GA identified 

Through a retinal examination by an optometrist or ophthalmologist, GA is identified by areas of retinal thinning associated with loss of photoreceptors and retinal pigment epithelium (RPE).  

Over time, this damage to crucial parts of the retina can eventually lead to the loss of these retinal structures, resulting in the sharply defined areas of cell loss characteristic of GA.

These areas may have a scalloped or geographic border, which is the reason for the name “geographic atrophy.” 19

What are the symptoms of GA 

GA often develops gradually over time and may not cause noticeable symptoms in its early stages. This is particularly so if it is only present in one eye to start with as the other eye will mask the problem. However, as the condition progresses, common symptoms may include:  

  • Gradual central vision loss which affects the ability to see fine details, read, drive, and recognise faces. This vision loss typically worsens over time as the atrophic areas in the macula expand. 
  • Blurred or distorted central vision. Straight lines may appear wavy or distorted, and objects may appear less clear or sharply defined. 
  • Visual distortions such as seeing blind spots or missing areas in their central field of vision. These can interfere with daily tasks that require clear central vision. 
  • Difficulty with low-light vision or experience reduced night vision. This can make it challenging to see in dimly lit environments or at night.  
  • Decreased contrast sensitivity making it harder to distinguish between objects of similar shades or colours. This can impact activities such as reading, driving, and navigating unfamiliar environments.  

It is important to note that the symptoms of GA can vary from person to person, and some individuals may experience more severe vision loss than others. Regular eye examinations and monitoring by an eye care professional are essential for detecting and managing GA, as early intervention (once approved and available in Australia) may help slow the progression of vision loss and preserve remaining vision. 

What is the cause?

The development of GA is complex and influenced by various genetic, environmental, and age-related factors. 

  • Genetic Factors: Certain gene variants are linked to a higher risk of developing GA and other forms of AMD. These include those in complement factor H (CFH), complement factor I (CFI), complement component 2 (C2), and complement factor B (CFB). These genes help regulate the immune system and inflammation, which are crucial in the development of AMD. 20
  • Environmental Factors: Smoking is the greatest modifiable risk factor 21 associated with an increased risk of GA. Other lifestyle and environmental risk factors include diet 22 and exposure to ultraviolet (UV) light. 23 
  • Ageing: Ageing is the primary risk factor for GA, however it is non-modifiable, meaning that it is unable to changed or controlled. As people age, cellular processes in the retina, including the function and maintenance of RPE cells, become less efficient. The accumulation of cellular damage and oxidative stress over time contributes to the degenerative changes seen in AMD, including GA. 24 25 26
  • Inflammation in the retina can lead to RPE dysfunction, photoreceptor damage, and ultimately the formation of GA lesions. 27

Social impact of GA 

Geographic atrophy (GA) can make it difficult for individuals to perform everyday tasks independently, significantly affecting their daily functioning and quality of life. 28 People with GA may find certain activities challenging such as reading, driving, watching television, completing household chores, recognising faces, 29 and the ability to perceive non visual communications.

More light may be needed for tasks such as reading, typing, or sewing, and may experience blurred vision, sensitivity to light, colour vision defects, progressive visual loss, a restricted visual field, and poor contrast vision. 30 GA may also impact a person’s ability to work, including volunteering which may lead to reduced community participation.

The impact of visual impairment goes beyond daily tasks. GA can cause emotional distress or even depression, anxiety about the future, frustration, and a sense of dependency on others. In addition, older adults with vision loss often have poorer physical and cognitive abilities, making them more susceptible to comorbidities, disability, and increased mortality. 

Visual impairment, particularly the near vision impairment characteristic of GA, is also a risk factor for frailty and increases the incidence of falls among the elderly. Falls are a significant public health concern worldwide, with a substantial portion attributed to visual impairment, including GA and AMD. 31

What treatments are available 

Emerging treatments 

There are now two treatments for GA which have been approved in the USA. These aim to slow progression of the disease rather than stop or reverse it. They both use complement inhibitors that target the complement pathway, which plays a role in the immune response. By reducing the activity of this pathway, the medicine aims to reduce inflammation and retinal damage in order to slow down GA progression and preserve vision.

1. Pegcetacoplan (Syfovre, Apellis Pharmaceuticals) 

Pegcetacoplan involves monthly or every-other-month intravitreal injections, which uses a fine needle to deliver the medication directly into the eye. Pegcetacoplan was approved for use in the US by the Food and Drug Administration (FDA) in February 2023. It is currently being evaluated for use in Australia by the Therapeutic Goods Administration (TGA). 32

2. Avacincaptad pegol (Izervay, Iveric Bio) 

Avacincaptad pegol was approved for use in the US by the Food and Drug Administration (FDA) in August 2023. It is also administered via monthly intravitreal injections. 

 

Late-stage clinical trials in progress 

There are several late-stage clinical trials in progress for other GA treatments with one in Phase 3 testing an oral capsule called ALK-001 (Alkeus Pharmaceuticals).

In Australia, there is also one trial in Phase 3 called the Phoenix trial testing an oral tablet called Tinlarebant (Belite Bio).  Also domestically, there is a trial in Phase 2 called ALXN2040-GA-201 testing an oral medication called Danicopan (Alexion Pharmaceuticals) and a Phase 2 trial called Parasol testing a gene therapy vector called JNJ-81201887 (Janssen). 

There are other international Phase 2 studies and several earlier stage clinical trials targeting the complement system, using neuroprotective agents, and testing ocular gene therapy and stem cell therapy that may provide alternative treatments for GA in the future. 33
 

Clinical care 

It is recommended that patients see their optometrist or ophthalmologist for further information. 

In preparation for potential new treatments coming to Australia for GA, The Royal Australian and New Zealand College of Ophthalmology (RANZCO) recently updated its referral pathway for AMD management (April 2024). It advises referral to an ophthalmologist if patients with GA are interested in learning more about potential GA treatments to enable them to make an informed decision. 

 

Download Information Sheet

Video presentation about GA

Presented at the Retina Australia Research Update in Canberra 16 May 2024 by Dr Carla Abbott, Centre for Eye Research, University of Melbourne

Dr Carla Abbott presented on the emerging treatments in geographic atrophy, a late stage of age-related macular degeneration (AMD).

For the first time, there are now approved treatments for geographic atrophy, also known as atrophic AMD, available in the USA, and it is expected these treatments will also be considered by regulators in other jurisdictions including Australia in the coming months.

Having access to potential new treatment options means it is important for clinicians to be thinking about who these treatments are best suited for and how best to discuss these new options with patients.

This talk covers the diagnosis of atrophic AMD, the potential new treatments on the horizon, the patients that these treatments are best suited for and collaborative management approaches between optometry and ophthalmology. The talk also discussed opportunities for patients to be involved in cutting-edge clinical trials for AMD.

Watch the presentation on GA here

hi everyone um so thank you very much for that very warm welcome and I’m really pleased to be here and be given this opportunity by the organizers to come and have a chat today so um really Keen to get your questions at the end but I’ll try and make sure that I’m speaking for those who aren’t able to see the slides um clearly as well so uh yeah as introduced I will be talking um mainly about geographic atrophy which is a late stage of age Rel Immaculate Generation Um but first I would just like to acknowledge the traditional owners of the lands we are all meeting on today and pay my respect to Elders past and present and i’ would also like to extend that respect to any traditional owners joining us here today as well um before we start just a couple of disclosures and acknowledgements so um I did get my flight paid for from Melbourne to attend um by rner Australia today but I have no other disclosures and um I work within the macular Research Unit at SI which is headed by Professor Robin gimer who’s a medical retina specialist and she has also contributed to this presentation and has a number of disclosures as listed so first just a little bit of the basics about age related macular degeneration and its clinical classifications um so we know that at late stage age related Ma generation or I’ll call it AMD for short causes central vision loss um so there is an image up there showing what things look like clearly um with a normal vision compared to Vision with um AMD where you have central vision um missing um and in terms of what you see at the back of the eye at the retina um there’s a gradation between or a clinical stage progression between when you have no aging changes at the retina at all um to when you start to get early signs of AMD which um to start with its very tiny little yellow dots um called drusen that start to develop they get bigger um when you get diagnosed as a clinical stage of intermediate AMD but both the early and intermediate stages don’t usually cause a lot of symptoms and it’s not until the late stages where you actually have photo receptor loss which are the cells that um detect light in the back of the eye um where you actually get that central vision loss and there’s two typ of late um AMD both what we call Geographic atrophy or I’ll be using GA for short since that’s what we’re going to mainly talk about today and that’s the atrophic type or you also get the neovascular type which is when there’s bleeding in the back there um so both stages and the uh Geographic atropy type can also change to the neovascular type as well so that’s just a little bit of an introduction to AMD and I’ll be focusing on the ga um dry type um today so although AMD is a leading cause of vision loss um affecting about one in seven people over 50 historically there has been quite limited treatment options to slow the vision loss um so neovascular AMD um had first intravital anti F treatments approved way back in 2004 in the US to start with and Then followed through in Australia um and so those treatments have been available now for 20 years um but Geographic atrophy the other late stage um has not had a treatment at all until the first ones were approved in the US last year um which is not actually approved yet in Australia but we’ll be talking a bit more about that today and in early and intermediate AMD there’s no Treatment available um currently to prevent people from progressing to the late stages either neovascular or atropic

disease so today we’re going to be talking about the emerging treatments for Geographic atrophy or GA so in February last year in the US the FDA approved Peg seta Coop plan um or also called ciorra as the first treatment to slow down the progression of GA and six months later in August they also approved um another um drug aasin caped pegol um as another um approach so these companies will also be applying in other jurisdictions including Australia um and the update on that at the moment is that um in Europe it’s still a under um evaluation and in Australia there hasn’t been any announcement yet about either Medicine by our regulating system which is the therapeutic Goods Administration um so we’re waiting um eagerly to hear what’s going to happen there and we’re going to talk about all this in a bit more detail um there’s also several other novel interventions currently in late stage clinical Tri for GA so what are these um new emerging treatments doing so um the most common pathway that’s being looked at is the complement pathway and trying to suppress inflammation so the complement pathway is a group of proteins that are helping the immune system to work and I do have an image up there of um the roundabouts of that system um but essentially there’s strong evidence that implicating overactivity of the complement pathway in um how AMD develops and hence there’s many trials for GA now that are um targeting potential treatments um that work on trying to inhibit the complement pathway so reduce that overactivity that’s um known and um the most common point of uh targeting that is by what we call the C3 and C5 inhibition um which we’ll talk about um in terms of the the medications so we’re going to go through some of the clinical trial data firstly that’s resulted in the approval of these um medications in the US so firstly um the peg a coop plan um there was two trials called The Oaks and the Derby trials and these are what’s called phase three trials which is the later stage um clinical trial development so there was over 1200 participants with GA across 200 sites internationally um that looked at um this Peg seta Co c-l um intervention and this is an anti- C3 intervention um and it’s using inital injections either monthly or every other month so that’s injections into the eye itself to um try and reduce the growth of the um atropic lesions so you can there is an image here that’s trying to point out that the macula is quite a large area at the back of the eye in the retina and the fobia what we call the fobia is the very center of the macula which has um the absolute finest Vision responsible for our absolute central vision so um and you can see there’s black areas in there in that image that are indicating the areas where the photo receptors are lost or we call it at Tropic area and so that’s where there’s no vision so these studies were looking at the 12 and the 20 month 24mth change in the total area of these GA lesions to see if the drug was able to slow down the growth of the lesions and this trials also looked at a subanalysis of the lesion area change away from the fobia as well so this is called extra fovial lesions um compared to lesions which are under the fobia called sub fovial lesions um and as I mentioned the fobia is that very central part of the macula and the trial has also been extended out to 60 plus months ongoing but we’ll show you the 12 and 24 months data now so for the um Oak study this is the 12 month lesion area data um in graph format here and for the whole data set so both the suboval and what we call the extra fovial lesions there was a 22% reduction in the size of in the lesion growth um compared to the people that didn’t get any of the um drug and um that’s for the monthly injections and for the every other month injections there was a 16% reduction in the growth of the lesions and then very interestingly when we looked at the pre-specified analysis of the extal lesions so the ones outside of the um fobia there was a 35% reduction um in the growth of the lesions in the monthly group and a 21% in the every other month so it seems to work a bit better for the to slow down the extra fob F lesions um but I will come back to this a little bit later as well in the derby study um again looking at both uh all the data Al together there was a 12% reduction in those that are receiving monthly injections and 11% reduction in those receiving every other month um injections and then when they look just at the extra fobal lesions there was a bit higher um rates so 25% reduction in um the every other month and a 16% reduction in the monthly

injections uh when we’re looking at both the Oaks and the Derby studies at 24 month 24 months you see a continuation in this um Trend so there was a 22% monthly reduction in those receiving the monthly um injections 18% in the every other month for Oaks and similar numbers uh 19% reduction in the monthly group for Derby and a 16% in the every other month um for Derby

um so just on to the other um drug as well that’s now been approved in the US the Evas and caped perol so this was a study with 448 participants internationally and they were getting um inovital injections um as well and looked at the 12mon change in the total area of the um lesions so um the data you can see a similar trend line where you get a 14% % reduction in those that are receiving the monthly injections um compared to people not receiving the injections um with one statistical method and they had another statistical method that showed very similar outcomes 177% reduction um now they did not um have an every other month option they just had a monthly injection option um this trial is also being extended up to 42 months ongoing um and they did not have an evaluation of the extra fobal versus Sub fob F data because anybody that had a subal leion was actually excluded from the study to start with so a little bit diff of differences in the study design in terms of so that’s the efficacy data how well it works um in terms of the Adverse Events St or the safety of these um medicines um both the Oaks and Derby compared to the ga two studies um were similar so there’s very small numbers of Adverse Events that are Sim similar to other intravital injection studies of course you’re putting a needle into the eye so there is a small risk very tiny risk of infection and so forth um just because that’s the approach um the main thing to note is there was seen an increased prevalence of the neovascular type of AMD onset in the treated groups compared to those that um did not get treated and that was a 12% um onset in those receiving monthly intravital injections 7% in those receiving every other month compared to 3% that got a sham injection um for the Oaks and Derby studies um and in the ga 2 study there was a 7% in those that were treated compared to 4% in the Sham now all these people were then treated with the anti-f injections which is the common um treatment for those with the wet type of AMD or neovascular AMD um so it was just a matter of treating those people with with that and as I said there is a small risk anyway of developing going from Geographic atrophy to um neovascular AMD the other thing of note that was actually not found in the trials um presumably because the cases are so low but it’s under um ongoing investigation is the American Society of Retina Specialists reported 13 cases um from Real World data of retinal vasculitis within 14 days of injection that was not found the trials um and there’s also been one case that was reported as well um using the um vasin caped pegle um drug and so there’s ongoing um investigation into that there’s no cause that has been completely clarified at this time and the exact rate of cases is unknown but it’s very tiny however because this um vasculitis can have a severe visual impact um so you can have uh great loss of vision um um this risk needs to be explained to patients at consent just comparing the two studies a little bit more The Oaks and Derby to The Gather to so they did have the same inclusion criteria for the leion size Baseline so the same um people going into the studies with the same types of leion size um but they did have a different inclusion criteria for vision so the Oak and Derby participants had to have what we call 69 or better Vision which is up to three lines of central vision loss on the chart um whereas The Gather two could actually be up to what we would call um 695 Vision which is actually greater than legal blindness in this country so there was quite a difference in who was included in terms of their um vision and then um for the leion location there was also a different criteria as we’ve already talked about a little so the Oaks and derby um participants could have the suboval um or extra fovial lesions well gather to could only have the extra fovial lesions so they actually excluded if anyone with the suboval lesions um and so the implication is because over half the eyes in the Oaks and Derby studies had suboval lesions and these generally have a slower growth rate than the extrao lesions it’s unsurprising that they had a slower reduction in lesion growth compared to the Sham group as the Sham group will also have a lower rate of growth in its in itself just to do with the underlying known how those lesions change and the other thing that was different between the studies was the criteria for neovascular AMD in the fellow eye or the other eye so the Oaks and Derby studies did allow people with neurovascular AMD in their fellow eye to um be enrolled and the ga two did not so um this means that the risk of neovascular AMD development is different between the studies because it’s known that people with neurovascular AMD and the fellow I are at higher risk of development neovascular AMD in their other eye already so just the key messages on this um so the um monthly or every other month injections of both of these medications have been shown to decrease the rate of GA lesion growth especially for extraoral lesions overall the medicines are generally well tolerated however there was an increased rate of neovascular AMD which can be managed and there are ongoing investigations into post study reports of retinol vasculitis which is in very small numbers and we still need to understand more um it’s important for patients to note that there was no noticeable day-to-day effects of visual function and that patients won’t notice an improvement in Vision when you get these injections which is quite different to the neovascular AMD where um you do get this Improvement in Your Vision after you receive the injection um so I’ll talk a little bit more in a moment about what this means in terms of clinical management but it’s just important to understand that um and of course there’s Ong glowing clinical trials to assess the longer term safety and efficacy of the um medications um for longer periods of time so just to recap the regulatory side so the regulatory approvals for these were obtained in 2023 in the US um both the European medicines Authority and the therapeutic Goods Administration in Australia are still considered ing um their decisions so it’s not currently available in Australia I’d just like to very briefly touch upon other emerging interventions in advanced stage clinical trials for GA so this is um a table I’ve got up here that was published in retina today in November and basically it’s just to indicate there’s a lot of studies happening I’m inan late stage clinical trials and there’s also a range of targets and delivery methods um that are being looked at including oral subcutaneous so under the skin or also oneoff subretinal approaches meaning under the retina um however most are still targeting this complement pathway that we talked about at the start I’m just going to very quickly touch on two of those to give you a flavor so the beauty of potential subcutaneous injections is there’s potential for self- administration so not having to go into the opthalmologist office every month to get your eye injection um so this one one is under the golden Phase 2 trial um which is looking at an inhibitor of complement Factor B targeting the liver because the liver is um responsible for the production of that complement Factor um it would be able to provide simultaneous treatment for Bilal GA you wouldn’t have to get injections in both eyes you just need an injection Under the Skin it has over 300 participants and they get their subcutaneous injections every four weeks this is still under trial um meant to be finished this year um so there’s no um regulatory approvals for this at the moment the other one to highlight is Gene and cell therapies which have a potential for a once off treatment so none of this every month having to do anything you get one treatment once um and then that’s it so the um thing with this is it does require a sub retinol injection which means under the retina so you need a vitro retinal surgeon and an operating theater but then you only need that once so what are these for so Gene therapies are to modify a gene that not functioning properly and it’s basically bringing in a viral Vector to bring in a healthy copy of the gene to act on this complement pathway for example cell-based therapies um are aimed at replacing the retinal pigment epithelium um which is an important layer below the retina known to be affected in AMD and this can be um applied as a suspension or otherwise on sheets or a scaffold and it can also it’s made using stem cell technology um either human embryonic stem cells or otherwise induced plur poent stem cells um and these are of course talks in their own right with a lot of detail about how all this works but just to give you a flavor the trials um for this is due for completion in 2029 these um later stage trials happening internationally um but at the moment there’s no regulatory approval anywhere so a little bit on how to get involved clinical trials if you’re interested um firstly why why why would we do this so I guess advantages are the potential to receive a successful intervention um knowledge that you’re contributing to the finding of interventions or improving the understanding of eye disease and also access to a Cutting Edge research team with regular reports sent back to your primary eye care practitioner however the points to keep in mind because trials aren’t for everyone um the randomized nature of trials mean that you don’t know and you’re reading um researchers don’t know because it’s masked if you’re in a group receiving interventions or not so um you have to be prepared that you might not be getting the um intervention and often um the way a lot of clinical trials are at the moment and again there there may be sort of changes in this is that at the moment you have to usually get into a central um location such as I Hospital regularly which involves regular travel um at the center for I research Australia there’s currently 13 trials at on offer for AMD and I’ve sort of just listed them all there um the trials are for all stages of AMD and sometimes the participation just involves a one-off research visit up to Interventional studies requiring two or three years of visits um but clinical care is always maintained with your referring practitioner and um letters are sent back um you can directly register your interest for a trial on our website so there’s a big button there saying register your interest when you go out and it just takes you through a guided process of filling in an online form um so it’s quite easy to do that if you’re interested of course you can also talk to your optometrist or opthalmologist um if you’re interested to register for trials and there’s usually trials available in each major um capital city um in terms of the changes in clinical practice so what are the implications of these emerging treatments becoming available for GA going to have on clinical practice so it really is a dawn of a new era because this is really the first time there’s ever been treatments available for GA um which is incredibly exciting and um opthalmologists and optometrists in Australia even though it’s not approved yet have been preparing new clinical guidelines for GA when the treatments become available so ransco which is the governing body of Opthalmology have just um published their new referral pathway um last month online and um the optometrist one is about about to be released very shortly as well so um that’s fantastic um it’s important to still recognize that the treatment is not suitable for everybody um and that it needs to be talked through on an individual basis to work out is this something that’s going to be right for this person or not um the clinician will need to be considering the progression risk factors for that person the treatment risk factors for that person and the treatment bur burden including that it at the moment at least it involves lifelong monthly ritual injections um and also the fact that the patient um just to look after their expectations it’s going to reduce the amount of vision loss due to GA over time but it’s not going to cause a day-to-day noticeable difference in the vision so the patient needs to be prepared for that because that’s different to wet AMD for example um Imaging of the retina over time is going to be key to clinical decision- making so it’s important to identify those at high risk of progression from early stage AMD to GA and our lab’s done a lot of work in this space identifying biomarkers and also it’s going to be important to those with ja lesions to work out who’s going to be most likely to progress to underneath the fobia and cause that fobal vision loss which is your really Central um central vision and as I’ve already said there’s a great importance on individual counseling on the risks and benefits and talking it through with each patient so just to sort of show you how we would look at the rate the risk of Le lesion growth over time so the Blackness that you can see in these images of the retina is the bits with no vision the parts that have atrophy and then you can look in different patients so we’ve got a patient up the top with extra fobal lesion starting outside of the phobia how it changes from year one to year two to year three and the risk that it might come in underneath the phobia um versus someone down the bottom there who’s had um a sub fobal GA and how that changes over time from each year so this is the type of equipment that we’ll be using to make those decisions and to talk with patients about the risks and benefits okay last slide take home messages so there’s currently two proven interventions to slow the progression of GA that are now approved and freely available in the US um there’s many more Trials of Novel interventions for GA underway those targeting this complement pathway are the most numerous and in later stage clinical trials um and these trials are international and are available in Australia including where I am at SI um and whilst the frequent inital injections are the mode of delivery of many new interventions other roots are also being explored which is really exciting and um uh you can rest assured that your um clinicians the optometrist and opthalmologists in Australia are preparing for this time when GA treatments become available here and um we are recognizing that conversations with our patients about individual treatment potential and risks is going to be very important so that’s um really what I wanted to share with you today and of course I’m happy to take any questions thank

you the question y so the question is what is the uptake of these um new drugs by patients in the US um I’m not really I mean I guess because it’s real world data it’s very hard I mean so we’re getting some real world studies um starting to come through but um I guess I wouldn’t have the answer for that necessarily offand I’m not sure if um if would you have more information about that Mary thanks Mary I’ll just repeat a little bit of that for those online so there’s been 250,000 um injection well people being uh choosing to uptake um the peg Co plan in the US since it’s been available um since February 2023 and um that the um rates of compliance and um so forth has been quite high in the trials and also most people are opting for a six to eight week um in conjunction with their clinicians um injections rather than every month so about 70% of people are um using the six to eight week regimen rather than monthly I think I got all that right yep so that’s there we go that was um Mary from app palis uh giving you the information from

directly uh yes just yeah yeah yeah I’ll just um just kind of question um you got this current practice in the US uh looking here when it finally gets to here what do you expect the cost will be will PS kind of product all of the um cost um yeah do do you want to just down and speak into the do you mind just because well because there’s people on um there’s another doubling of the audience online if you don’t mind so I’ll just repeat the question the question was basically once it’s actually approved in Australia this new drug what is the cost to patients going to be is it going to be on the PBS or is it going to be user pay yes so the company has plans to seek reimbursement through the PBS um so we plan to submit next year following from on from getting uh regulatory approval by the therapeutic Goods Association Administration sorry TGA in the US what’s the position um the in the US there’s a different market so it’s they have a complete completely different model so in Australia you know we have a universal healthcare system um whereby the majority of therapies are hopefully funded and available on PBS and patients pay co-pay um in the US they’re largely funded by um Private health insurers there is a different kind of a fund called Medicare which is completely different to Australia it’s not the same Universal type of an arrangement um so it’s a completely different healthare system in term terms of paying for therapy so patients usually have to have Private health insurance if they’re not um able to afford um therapies out of pocket should start by saying sounds

fantastic I hope that helps

thank probably have time for one more question if there’s one more question that yeah while you come coming down uh so essentially the question from the audience was uh what why was it approved in the FDA and not approved in the European

market um it’s a good question but each country has its own um regulatory body as you know so FDA and the US EMA in Europe in Australia it’s the TGA um these countries do um conduct their um regulatory evaluation of the submission in different ways um they are independent um but they do look to what’s happening in the rest of the world so for example Australia will be ke the the Department of Health in Australia will be very interested in what’s happening in Europe but they operate completely independently make their own um decisions as to whether or not a prod they consider a product to be um efficacious safe and they also look at quality as well from a regulatory perspective

thank you just in the interest of time we might move on to our next speaker and thank Carla for a wonderful presentation