“Macular degeneration,” changes occurring in macular which results in the visual impairment, and “diabetic retinopathy,” which takes place in retina resulting from diabetic complication, are both senile eye diseases.
Recently, the number of the elderly with the disease has been growing fast along with the increase of aged people. Medicines to treat these diseases, however, are all imports. The therapies for macular degeneration are “Eylea” (compound: aflibercept)’ made by Bayer바이엘 and Lusentis (compound ranibizumab)’ made by Novartis노바티스. The prices of the two drugs are high, about 1 million won ($888) a month.
This explains why the government has set about to develop new medicines. The Ministry of Health and Welfare보건복지부(MOHW) has been conducting a project titled “Fist-in Class diabetic retinopathy therapy development (from Dec. 1, 2015, to May 31, 2020)” as part of its high-tech medical technology development programs. And the Ministry of Trade, Industry and Energy산업통상자원부(MOTIE) has been pushing to develop medicines to treat macular treatment and dry eye syndrome as its key technology development project.
One thing these projects have in common is to develop cheap and effective drugs to treat geriatric ophthalmic disorders. Another common feature is that Professor Yang Jae-wook양재욱 at Inje University Busan Paik Hospital인제대 부산백병원 is in charge of these projects.
Korea Biomedical Review met with Professor Yang to discuss the possibility of developing new treatments for these eye diseases. Yang, concurrently the head of Technology to Business (T2B)-based Infrastructure Center for Ocular Disease, also has supported their entry into clinical trials by, for instance, evaluating pre-clinical effectiveness test to develop medicines and medical equipment.
|Professor Yang Jae-wook at Inje University Busan Paik Hospital stresses the importance to develop therapies for macular degeneration and diabetic retinopathy, during a recent interview with Korea Biomedical Review.|
Question: What is the reason behind your decision to develop therapies for macular degeneration and diabetic retinopathy treatments?
Answer: The prevalence rate of eye diseases has increased along with population aging, but there have been few therapies. The word eye disease brings to people’s mind cataract, but macular degeneration is a more common disorder, inflicting one in every four people ages 65 or older. There has been much progress in the development of diabetic retinopathy, but its early preventive treatment is still insufficient.
When “Lusentis” and “Eylea” were introduced in Korea in 2007, they could receive insurance benefits for only five times at the most. Now the maximum number of insurance coverage has risen to 14 times, meaning the payment made by health insurance budget for a patient has increased nearly three times. This is why the development of therapies has become imperative.
Moreover, some patients have to take Lusentis or Eylea 14 times or more. Because patients can’t get medical insurance for the 15th time, they have to pay more than 1 million won a month to buy them. There are not many patients who can afford to continue to buy them. And therefore most of the patients return to the anticancer therapy, Avastin.
In other words, if we can develop cheap and improved therapies, the treatment will receive attention not only at home but from all over the world.
Q: The government must be highly interested in the outcome of the project to develop treatments.
A: The government, from the previous Park Geun-hye administration, has been highly interested in diabetic retinopathy project and has often asked us to send them an interim outcome. So much so that we have to prepare for the post-2020 program even though the final result of the ongoing project has yet to come out. This is because we have to undergo a preliminary feasibility checkup. We have also heard positive evaluation about the project to develop the diabetic retinopathy therapy from government officials.
Q: We are also curious about what the “T2B-Based Infrastructure Center for Ocular Disease” does?
A: In August 2015, the ministry designated the T2B-based Infrastructure Center for Ocular Disease as a special organ which provides the evaluation services of pre-clinical effectiveness, appointing one center for one disease. But there had not been a center to deal with eye diseases. This center plays a role in connecting hospitals and pharmaceutical companies to develop new drugs.
The center decides whether they should go on or stop at the pre-clinical trial stage. It analyses and informs wrongs if there are any, and helps them to develop drugs. It also corrects a wrong disease target in the process. The center received 7.5 billion won from the ministry and 1 billion won from Busan Metropolitan Government. And it provides about 70 percent of the total for businesses developing the therapies. Ventures or small-and medium-sized enterprises get up to 80 percent of costs while big businesses can receive 50 percent concerning pre-clinical trials. As of May 2017, the center was conducting 13 projects -- 12 for developing medicines and one for making medical equipment.
Q: What sets you center apart from other similar centers?
A: Among the 20 researchers at the T2B center, five have doctoral degrees, and the other 15 have master degrees. It has ophthalmic equipment that other Korean hospitals do not, and has animal models for which it has directly secured patents. When we test a diabetic therapy, for example, we have to conduct an animal test first and needs an animal as an experiment object model. Some animal models are very expensive worth billions of won or even tens of billions of won. In actuality, a U.S. company has asked us to evaluate pre-clinical trial evaluation of new drugs after watching our animal model patent. We conducted the evaluation for three months, and the U.S. Food and Drug Administration (FDA) approved the research later.
Q: Some point out that it isn’t difficult to produce results as if new drugs are effective in pre-clinical trials.
A: Right. It’s just what people say wrong evaluation. You may be able to generate useful data from evaluations not based on correct animal model experiment, but the resultant drugs cannot come into the market. Many news stories about the development of new medicines actually belong to the Technology Readiness Level (TRL) of second or third phases. What the T2B center does is evaluating the sixth phase (evaluation of the pilot products’ function) and seventh phase (functional evaluation of prototype products).
Q: Are there any research that completed pre-clinical trial phase and moves toward clinical test stage?
A: A case in point is a dry eye therapy being jointly developed with YuYu Pharma유유제약. The center has already finished pre-clinical trials and is about to enter into clinical trials. If the substance candidate is worth of 10 won, the value of the substance will go up to 100 won or 1,000 won if the compound proves its efficacy through pre-clinical trial evaluation. The price of the substance will jump to 10,000 won if regulators approve the Phase 1 clinical trial, and rocket to 100 million won if it enters into the Phase 2, which means the surge as the phase proceeds.
Q: Aside from research, you have been treating treatments in the field consistently. In Korean medical situation, it isn’t easy to do the two things at the same time.
A: Whenever I am in hard times, I recall the maxim, “Doctors lose their touch the moment they stop clinical activities.” I believe it’s better to develop therapies as a clinician however hard it may be. Developing new drugs can contribute to helping patients. And many doctors have been struggling for that. I hope more people will recognize there also are doctors fighting day and night with the aim of developing new drugs.
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