Lisa Feng 0:02
Hello, and welcome to our In Conversation with Zhaoke, Podcast Series, where leading scientists will exchange views with doctors, surgeons, and other experts in the Ophthalmology field. We will discuss a number of issues affecting the eye, which impact tens of millions of patients each year. We will also focus on several drugs we have in our pipeline which we believe will provide future solutions and relief to patients as well as providing context on the ophthalmology market in China.
In today’s episode, Founder, Chairman and CEO of Zhaoke Ophthalmology, Dr. Benjamin Li will be discussing glaucoma with Dr. Mandy Li, Senior Vice President, Research and Development, at Zhaoke Ophthalmology.
Dr. Benjamin Li has over 25 years of experience in pharmaceutical research and development. Since 2014, he has been serving as the Vice President of the Hong Kong Biotechnology Organization, and since 2016 he has been the President of the Guangzhou Pharmaceutical Organization. Dr. Li has won multiple awards for his work and is an Adjunct Professor and Honorary Fellow at the Hong Kong University of Science and Technology.
Dr. Mandy Li is trained as a research scientist and holds a Ph.D. in biochemistry from The Chinese University of Hong Kong. As Head of R&D at Zhaoke Ophthalmology, Mandy oversees drug development from inception in a science lab all the way through clinical development. Her team is rapidly expanding from 40 members at the beginning of the year to 64 at the end of August. The recent milestone including the successful completion of our Phase III study for CsA Ophthalmic Gel for Dry Eye Disease is a testament to the commitment and capabilities of her team.
Our topic today is glaucoma, a disease affecting approximately 64.3 million people globally and the second cause of blindness in the world. Glaucoma is becoming a significant issue in China with 15.3 million patients experiencing the highest rate of blindness in the world from one of the two most common types of glaucoma.
Today, we will analyze the causes, symptoms and treatments for Glaucoma, as well as the new treatments being developed by Zhaoke Ophthalmology, which we hope will have a meaningful impact on the millions of patients affected by the disease.
Mandy Li 2:44
To begin, I wanted to give you some context on glaucoma. This is a common eye condition that appears when the optic nerve that connects the eye to the brain gets damaged. If left untreated, it can cause irreversible blindness. As the nerve gradually deteriorates, blind spots begin developing in one’s visual field. The damage of the nerve then leads to increased pressure in the eye, caused by fluid building up in the front part of the eye. Usually, the internal fluid will drain out at the angle where the iris and the cornea meet. However, when this fluid is overproduced or the drainage isn’t effective, pressure increases inside the eye, causing blindness. First, let’s try to understand why glaucoma occurs and if there are ways to prevent it?
Dr. Li 3:40
Glaucoma can develop in an individual for several reasons. The disease tends to run in families and in some people, scientists have identified genes related to high eye pressure and optic nerve damage. It can affect people of all ages, but is most common in adults in their 70s and 80s. Ethnicity can also be a factor as people of African, Caribbean or Asian origin are at a higher risk. It's not clear whether it is possible to prevent glaucoma but having regular eye tests should help detect the disease as early as possible. Unfortunately, glaucoma doesn’t usually cause any symptoms initially, which makes it difficult to detect early, and can make prevention more challenging.
Mandy Li 4:37
So, when patients start suffering from symptoms, it can be too late. What are some symptoms that glaucoma patients might experience?
Dr. Li 4:47
Glaucoma is a disease that can lead to loss of vision if it's not diagnosed and treated early. Typically, it develops slowly over a few years and initially affects the peripheral vision first, especially the part of your vision that’s closest to your nose. This means the majority of people don’t realize they have glaucoma initially. Usually, the first symptoms include blurred vision and seeing rainbow-coloured circles around bright lights. Both eyes are usually affected but it could be worse in one eye. Other common symptoms are intense eye pain, nausea, red eye and headaches.
Glaucoma is becoming a huge healthcare problem in China, as East Asians experience the highest rate of blindness in the world, from one of the two most common types of glaucoma. For people of Asian ethnicity, primary angle-closure glaucoma or PACG is more prevalent. This occurs when the iris bulges forward to narrow or block the drainage angle formed by the cornea and iris. China’s rapidly aging population will also contribute to an increase in the number of patients affected by glaucoma in the country, as older people are more likely to suffer from the disease. In addition, glaucoma is significantly underdiagnosed in China with a diagnosis rate of 20% vs 78.2% in the US.
Fortunately, diagnosis rates are beginning to rise as more specialized hospitals and private eye clinics in China come onstream. AI-enabled technologies may also help improve the diagnosis rate significantly. As more people are diagnosed with eye diseases, demand for better treatment increases, leading to an improved standard of care in the domestic market.
Mandy Li 7:11
What current treatments are available for those suffering from glaucoma?
Dr. Li 7:16
Most of the time, glaucoma can be detected through routine eye tests such as vision tests and measurements of the pressure inside your eye, before it causes any noticeable symptoms. There are currently three common treatments for glaucoma: eyedrops, laser treatment and surgery. Unfortunately, the treatment cannot reverse any loss of vision that has already occurred, although, and this is very important, it can help stop eyesight deteriorating further. For PACG: the solution is immediate treatment in hospital with medicine to reduce the pressure in the eye, followed by laser treatment. For Secondary Glaucoma, which refers to any form of glaucoma in which there is an identifiable cause of increased eye pressure: the solution is eyedrops, laser treatment or surgery, depending on the underlying cause. For Childhood Glaucoma: the solution is surgery to correct the problem in the eye that led to the build-up of fluid and pressure.
Mandy Li 8:32
Can you tell us more about the three current solutions for glaucoma and what they involve?
Dr. Li 8:39
Eye Drops are the primary treatment for glaucoma, as they reduce the pressure in your eyes. However, people usually need to try several types before they find the one that works best and sometimes people need to use more than one type at a time. Additionally, these eyedrops can cause unpleasant side effects, including eye irritation, and some eyedrops are not suitable for people with certain underlying conditions. Laser treatment can be used where a laser is carefully aimed at part of your eye to stop fluid building up inside it. However, laser treatment is usually carried out when awake and patients will usually feel pain or heat during the procedure and may still need to continue to use eyedrops. The most common type of surgery for glaucoma is called trabeculectomy. It involves removing part of the eye-drainage tubes to allow fluid to drain more easily. Glaucoma surgery may be carried out under local or general anesthetic. However, after surgery, eyes may water and be red, and vision may be slightly blurred for up to six weeks, but should return to normal.
Zhaoke Ophthalmology is currently developing a new treatment for glaucoma. Mandy, can you explain how it differs from standard treatments currently available in the market?
Mandy Li 10:13
There are eight different forms of glaucoma, mainly due to anatomic and genetic differences, which is why we have multiple drugs in our pipeline targeting the disease. Our focus for glaucoma drugs is on developing best-in-class options that will raise global standards and provide a better experience for patients. We are concentrating our efforts on preservative-free options that have less side effects, which we can provide via single dose sterile packaging. Our comprehensive pipeline includes seven drugs that cover different types of glaucoma. To simplify things for our listeners, I will highlight three of our drug candidates here.
The first is Bimatoprost, a potential first-to-market generic in China. It will potentially be the first preservative-free generic commercialized in China, which will help improve patient comfort during treatment and lower the risk of allergies. It will have single dose sterile packaging, which enables the drug to be preservative-free and sterile.
The second is Bimatoprost Timolol, another potential first-to-market generic Bimatoprost Timolol in China. While similar sounding to the first drug, this treatment is used for more advanced stages of glaucoma, with increased pressure in the eye. We submitted an abbreviated new drug application to the National Medical Products Administration in October 2020 and expect to receive approval in the first half of 2022. We passed the on-site GMP inspection for the manufacturing facility of Bimatoprost Timotol in May 2021, which ensures that products will be consistently produced and controlled according to stringent quality standards. This also marks an important step in the overall ANDA review process.
And finally, Levobetaxolol Hydrochloride, a generic to Betaxolol Hydrochloride Eye Drops being developed by Zhaoke Ophthalmology to lower the pressure in the eye. This is potentially the first-to-market generic of levobetaxolol targeting glaucoma in China. We have recently announced that this drug has met its primary endpoint in a Phase III clinical trial, decreasing the intraocular pressure in eight weeks compared to the baseline. This new formulation has been shown to be more effective and better tolerated than the original treatment. Zhaoke Ophthalmology plans to submit a NDA to the NMPA by the first half of 2022, with the aim to receive approval in 2023 and to manufacture the product in-house after regulatory approval.
Dr. Li 13:04
What excites me the most is that these new treatments, once available, can make a meaningful difference to potentially millions of sufferers from glaucoma in China. As Mandy said, we expect the first products to receive approval and be commercially available in 2022.
Lisa Feng 13:30
Thank you for joining me on this podcast Dr. Benjamin Li and Dr. Mandy Li. I am Lisa Feng, Chief Financial Officer of Zhaoke Ophthalmology. I hope you have enjoyed listening to our podcast. Please feel free to listen to our previous episodes. We look forward to talking to you again soon in the next episode of our In Conversation with Zhaoke Podcast Series. Thank you.