Interview with Dr. Mike Francke, Head of the Task Force on the Treatment of Progressive Myopia, Paul Flechsig Institute for Brain Research, University of Leipzig
Many people all over the world suffer from myopia, also known as nearsightedness. A severe elongation of the eyeball is the cause behind it. If it continues to progress, it ultimately leads to complete loss of vision. Now an innovative medical device intends to stop this progression in the future.
Dr. Mike Francke
In this interview with MEDICA-tradefair.com, Dr. Mike Francke talks about the new and unique treatment approach, explains its functionality and effectiveness and reveals the next steps of his task force.
Dr. Francke, what is pathological myopia?
Dr. Mike Francke: Pathological myopia is a progressive, ongoing and therefore severe form of nearsightedness. It has pathologic consequences for the retina and choroid. Nearsightedness is caused when the eyeball grows too long. You can compare this to a balloon that keeps getting bigger due to an increase in internal air pressure, because it is mechanically too soft, whereas a soccer ball is dimensionally stable. In the case of pathological myopia, the sclera is too weak in terms of biomechanical properties. The retina and blood vessels are unable to withstand the stretching and tear. Not only does this result in severe vision loss but also leads to retinal degeneration and subsequently blindness.
How long have you searched for a myopia treatment and why?
Francke: Our task group has worked on this new treatment for progressive myopia since 2009. Our goal is to intervene earlier before the pathological consequences and damages to the retina occur. So far, research does not sufficiently indicate that this is a major and global issue for society. Despite the enormous demand, the number of task forces that focus their research on this subject is still rather scant.
What are your successes so far?
Francke: We utilize the principles of so-called collagen cross-linking, the cross-linking of collagen fibers of the sclera. To do this, we adapt a cornea treatment that has been clinically established since 2004 and whose effects after one-time application last between ten to fifteen years. We are very optimistic that this is also possible with a myopic eye. A procedure that is effective for treating Keratoconus and thus the anterior, still transparent segment of the eye, might also work in the posterior, no longer transparent segment. We were able to show in animal experimental and preclinical studies that this treatment approach actually works. It can prevent eye elongation or at least drastically reduce it without causing damage to other eye tissue like the retina or choroid.
In pathological myopia, the eye continues to expand until blindness occurs.
What does your future procedure to treat human myopia look like?
Francke: Since this is a surgical procedure, we are developing a medical device that is able to apply a mediator substance – a so-called photosensitizer – and light. Because of its shape, we affectionately call our surgical system ”Leipziger Löffel“ (English: Leipzig Spoon). During the treatment, first, the conjunctiva between the orbit and eye is opened to enter the eye socket. The photosensitizer is then applied to the outer eye in the form of riboflavin – that’s Vitamin B2. This yellowish liquid has to subsequently penetrate the tissue and sclera, respectively. Afterwards, this portion is irradiated with blue light. Currently, this still requires a major surgical procedure followed by a two to three-day hospital stay. Our goal is to develop a minimally invasive procedure that might even be performed in an outpatient setting in the future.
What are the risks of this type of treatment?
Francke: Using animal testing, we were able to determine which blue light dosages are efficient and which dosages cause damage to the tissue. We consider the actual treatment to be very safe. There are merely the common risks for any surgical procedure, such as an eye infection for example. Of course, there is a chance – and we don’t know this yet because we have not seen this with animals yet – of a stiffening of the sclera, which increases the risk for glaucoma. However, there are no indications for this whatsoever because the preclinical trials have so far never shown any damage to other segments of the eye.
During treatment with the "Leipzig Spoon", vitamin B2 is applied to the back of the eye.
You have recently been to China as part of your research project. Why China?
Francke: We went to China at the invitation of the German Ministry of Education and Research since we are developing a product that is especially interesting and important for the Chinese market. Approximately 30 to 40 percent of the German population is nearsighted. Meanwhile, this percentage ranges between 70 and 90 percent in Asian countries. Thanks to urbanization, early entrance into school, reading in poor lighting conditions and less time spent doing outdoor activities, this number continues to increase. Due to this genetic predisposition, the Chinese market is a major market for us and our medical device. We are able to establish initial ties with potential investors to gain access to this market in the coming years.
What are the next steps for your project?
Francke: We are presently funded by the German Ministry of Economic Affairs and Energy as part of the EXIST Transfer of Research. Over the next two years, during which we are still receiving this support, our goal is to further develop the medical device with the help of sponsors from the medical device industry to where we will be able to attempt the first treatment of a patient. If we manage to do this and thus succeed in demonstrating the efficiency and safety of this method, we have laid the best foundation for great investments in this development and the approval of this medical device. The approval process including clinical trials takes another two years. The CE certification increases our chances of breaking into international markets. Ultimately, we will then have a new type of therapy for a disease for which there is no efficient treatment method yet.
The interview was conducted by Elena Blume and translated from German by Elena O'Meara. MEDICA-tradefair.com