Recently HKN News on-line reported the following:
近視の進行を抑える国内初の目薬 製造販売を正式に承認 厚労省
2024年12月27日 17時06分
近視の進行を抑える国内で初めての目薬について、厚生労働省は27日、製造販売を正式に承認し、今後、身近な医療機関でも処方されるようになると期待されています。
承認されたのは、大阪の製薬会社「参天製薬」が開発した目薬「アトロピン硫酸塩水和物」です。
近視は多くの場合、体の成長とともに眼球が前後に伸び、網膜でピントが合わなくなって進行するとされています。
開発のために軽度から中等度の近視の子どもを対象に行われた治験では、目薬を投与したグループは投与しなかったグループと比べて、近視が進行する速度が緩やかになり、眼球の伸びも抑えられたということです。
今月開かれた厚生労働省の専門家部会で国内での製造販売を認めることが了承され、厚生労働省は27日正式に承認しました。
近視の進行を抑える目薬が承認されたのは国内では初めてです。
これまでは海外で承認された同様の成分の目薬を一部の医療機関の医師が個人輸入する形で使っていましたが、今後、身近な医療機関でも処方されるようになると期待されています。
会社によりますとこの目薬には公的な医療保険は適用されず、全額が自己負担になる見込みだということです。
海外で承認された目薬を使っていた病院は
東京 文京区にある東京科学大学病院の眼科では、軽度や中等度の近視の子どもに対し、シンガポールなど海外で承認された目薬を輸入して使用しています。
同様の成分の国産の目薬が承認されたことから、この病院では患者の希望を踏まえて切り替えていく方針で、この日も医師が近視の治療のために受診した子どもと親に検査の結果を示しながら新しい目薬について説明していました。
横浜市から訪れた小学3年生の男の子の母親は「子どもの近視が心配で毎回、片道1時間以上かけて通院しています。国産の薬が出て最寄りの眼科のクリニックで処方してもらえるようになると助かります」と話していました。
五十嵐多恵医師は「国産の薬が承認されたことで医師としても安心して処方できるようになる。個人輸入の必要もなくなり、国内で近視の治療が普及する大きな一歩になる」と話していました。
日本近視学会 理事長「近視が進行しやすい子どもへの使用想定」
承認された目薬の治験データの分析に関わった日本近視学会の理事長で、東京科学大学の大野京子教授は、この目薬は主に近視が進行しやすい子どもへの使用が想定されているとしています。
目薬の有効性が示された治験も5歳から15歳の軽度から中等度の近視の子どもを対象に行われていて、大人や、子どもでも強度の近視の場合はすでに進行が収まっているケースが多いため、効果を期待しにくいということです。
Translation
Ministry
of Health, Labor and Welfare officially approves manufacturing and sales of
Japan's first eye drops that suppress the progression of myopia
On the 27th, the Ministry of Health, Labor and Welfare officially approved the manufacturing and sales of Japan's first eye drops that could suppress the progression of myopia, and it was expected that they could be prescribed at neighborhood medical institutions in the future.
The eye drop approved was the "Atropine sulfate hydrate" developed by Osaka pharmaceutical company "Santen Pharmaceutical (参天製薬)".
In many cases, myopia would progresses when the eyeball stretched back and forth as the body grew, and the retina was no longer able to focus.
In clinical trials on myopia development conducted on children with mild to moderate myopia, the rate of myopia progression was found slower and the eyeball stretching was also suppressed compared to the group that did not receive the eye drops.
A Ministry of Health, Labor and Welfare expert committee held this month approved eye drops manufacturing and sales in Japan, and the Ministry of Health, Labor and Welfare officially approved it on the 27th.
This would be the first time an eye drop that could suppress the progression of myopia was approved in Japan.
Until now, doctors at some medical institutions imported eye drops with similar ingredients approved overseas, but it was expected that they could be prescribed at local medical institutions in future.
According to the company, public medical insurance would not cover these eye drops, and patients had to pay the full cost themselves.
Hospitals that used eye drops approved overseas
The
ophthalmology department at Tokyo University of Science Hospital in Bunkyo
Ward, Tokyo, imported eye drops approved overseas, such as from Singapore, for
children with mild to moderate myopia.
As domestic eye drops with similar ingredients approved, the hospital planned to switch to them based on the patient's wishes, and on this day doctors were explaining the new eye drops to children and their parents who came to the hospital for myopia treatment, and showing them the results of the tests.
The mother
of a third-grade boy who visited from Yokohama City said, "I'm worried
about my child's myopia, so I always travel more than an hour each way to the
hospital. It would be helpful if a domestically produced drug was available and
I could get it prescribed at the nearest eye clinic."
Dr. Igarashi Tae (五十嵐多恵) said, "With the approval of a domestically produced drug, doctors can prescribe it with confidence. There will be no need for personal imports, and this will be a big step towards the widespread use of myopia treatment in Japan."
Japan Myopia Society President: "Intended for use in children whose myopia is likely to progress"
Professor Kyoko Ohno (大野京子) of Tokyo University of Science, president of the Japan Myopia Society, who was involved in analyzing the clinical trial data for the approved eye drops, said that the eye drops were intended for use primarily in children whose myopia would likely progress.
On top of
clinical trials that demonstrated the effectiveness of the eye drops conducted
on children aged 5 to 15 with mild to moderate myopia, regarding the trials on
adults and children with severe myopia, as the progression of the condition had
often already stopped, it was difficult to expect seeing any effect.
About this
approval, Professor Ohno said, " In Japan there is a particular trend
of an increase in the number of children with myopia, yet there are only a
limited number of medical institutions that import eye drops from overseas, and
until now many patients are only able to monitor their condition with eye glasses
etc. Now domestically produced eye drops have been approved and they can be
prescribed by ophthalmologists across the country, yet it is also important to
improve lifestyle habits to prevent myopia from progressing, such as avoiding
looking at close objects for long periods of time, and to spend more time
outdoors."
So, Japan has officially approved the
manufacturing and sales of eye drops that can suppress the progression of
myopia, this will be a big step towards the widespread use of myopia treatment
in Japan. But experts have pointed out that it is also important to improve
lifestyle habits to prevent myopia from progressing, such as by avoiding
looking at close objects for long periods of time and spending more time
outdoors. Apparently playing video game on mobile phones etc. continuously for
a long time will be bad for the eyes.
Note:
1. Santen
Pharmaceutical Co., Ltd. (参天製薬株式会社) is a Japanese pharmaceutical company specializing in ophthalmology.
With its ophthalmic products Santen holds the top share within the Japanese
market and is one of the leading ophthalmic companies worldwide with its
products being sold in over 50 countries.
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