"Myopia miracle drug" low-concentration atropine is on sale: ophthalmology experts remind that not every child can use it

On March 26, the 0.01% atropine sulfate eye drops produced by Shenyang Xingqi Ophthalmic Pharmaceutical Co., Ltd. began to be sold in Internet hospitals, and patients can consult and prescribe drugs online in online hospitals.

According to the news released on the official website of the State Drug Administration, the drug has been approved for marketing on March 5 to delay the progression of myopia in children and adolescents, and has become the first "national medicine quasi-word" atropine sulfate eye drops in mainland China.

Upstream News (report mailbox: [email protected]) learned that low-concentration atropine has been on the market in many countries and regions for many years, and there have been cases of parents asking people to purchase on behalf of others at high prices, but due to the unstable supply, it is still difficult to find a drug. Now that the drug has been approved, it has relieved the urgent need of parents.

Tao Yong, an ophthalmology expert from Beijing Chaoyang Hospital affiliated to Capital Medical University, told upstream news reporters that at present, atropine eye drops are the only drugs that have been proven by evidence-based medicine to effectively delay the progression of myopia, but before starting to prepare for the use of atropine to prevent and control myopia, patients need to go to the hospital for medical optometry and accommodative examination, and if it is suitable for use, it should be used under the guidance of a doctor. 

Purchasing on behalf of other brands of atropine eye drops on the Internet. Image source/interviewee 

The "myopia miracle drug" is on the market, and parents may say goodbye to purchasing

On March 11, the State Drug Administration announced that the 0.01% atropine sulfate eye drops produced by Shenyang Xingqi Ophthalmic Co., Ltd. (hereinafter referred to as "Xingqi Ophthalmology") was approved for marketing to delay the progression of myopia in children and adolescents, becoming the first "national medicine quasi-word" atropine sulfate eye drops in mainland China.

0.01% atropine sulfate eye drops is not a new drug, it has been used for the prevention and control of myopia in many countries and regions for many years, and has been used in the first-line clinical practice of ophthalmology in many hospitals in China.

Low-concentration atropine is regarded as the "miracle drug for myopia", and some parents will choose to purchase drugs from other regions or prescribe drugs in hospitals through relationships in order to alleviate their children's myopia. Mr. Wang, a 40-year-old Harbin parent, told reporters that his 7-year-old daughter is in the second grade of primary school. Although he has always paid great attention to his children's eye habits, his children still have a tendency to become myopia. A year ago, Mr. Wang learned about low-concentration atropine eye drops through a friend who worked in the hospital, and began to purchase them through purchasing channels. However, the purchasing price varies, and sometimes it is out of stock. For example, the price of a certain brand of medicine fluctuates between 460 yuan and 800 yuan per box. "What worries me the most is that there is no guarantee that the drugs purchased are genuine. Mr. Wang said, "After the new drug is launched, we can prescribe it in the hospital normally!"

The reporter learned that many parents are showing their own powers and buying drugs on their own. A parent in Jiangsu Province purchased low-concentration atropine eye drops from an eye hospital in Shandong Province for a long time through relatives.

Although a box of eye drops is as high as 800 yuan, there are still parents who do not hesitate to spend a lot of money to buy a "myopia miracle drug". The reporter saw on multiple platforms that many netizens shared their experience in purchasing and using low-concentration atropine eye drops, and some of them posted online posts for publicity.

The approval of the mainland's first low-concentration atropine may bid farewell to the cumbersome purchasing process, which undoubtedly alleviates their anxiety.

Xingqi Ophthalmic Medicine announced that the eye drops alone can delay the progression of myopia by 60%, and has a minimum rebound effect after drug withdrawal, and has a cumulative effect on myopia control, which is a reasonable concentration for myopia management in children and adolescents with myopia at this stage. It can be used flexibly and can be used in combination with optical control means.

On March 26, the reporter learned from Shenyang Xingqi Eye Hospital that the 0.01% atropine sulfate eye drops produced by Xingqi Ophthalmology have been sold in the hospital's Internet hospital, and patients can consult and prescribe drugs online in the online hospital at a price of 298 yuan for 30 pieces. The staff told reporters that there have been many patients consulted in the past two days, and if you can't register, you can wait two days to register to buy medicine.

The 0.01% atropine sulfate eye drops produced by Xingqi Ophthalmology were approved. Image source/Screenshot of the official website of the National Medical Products Administration 

Before using atropine eye drops, optometry should be directed by your doctor 

The reporter noticed that the topic of low-concentration atropine has always been very high, but there are mixed reviews among parents.

Some parents thought that the eye drops might have side effects, and there was a rebound after stopping the drug, and some parents became loyal fans of atropine. In an exchange online post, a parent said, "After the child stopped taking low-concentration atropine, the myopia increased by 100 degrees within a month, and the rebound was great, and now the drug has been stopped and dare not use it again." Some parents also said, "With the use of OK glasses for two years, the child's myopia is no longer serious." ”

The reporter noted that the use of the drug is also controversial in the industry, and the controversy is related to the concentration of the drug and the side effects. In February 2023, a research team from the University of Chinese of Hong Kong published an article in the Journal of the American Medical Association (JAMA) on "A Comparative Study of Low-concentration Atropine Eye Drops and Placebo on the Incidence of Myopia in Children, LAMP2 Randomized Clinical Trial", which concluded that in non-myopic children aged 4-9 years, 0.01% of atropine was not significantly different from placebo.

The conclusions of this paper also mention that the use of 0.05% atropine eye drops at night significantly reduced the incidence of myopia and reduced the percentage of participants with rapid myopia metastasis at 2 years of age compared to placebo.

Other studies have shown that the higher the concentration of atropine, the stronger the control effect, but excessive concentrations will bring obvious side effects. The results of the ATOM (Atropine for the Treatment Of Myopia) study conducted by the National Eye Centre of Singapore showed that atropine eye drops can effectively delay the progression of myopia in children, and atropine eye drops at a concentration of 0.01% have better sustained effects and a better safety profile. Through 5 years of long-term follow-up experiments, the results showed that the higher the concentration of atropine, the better the myopia control effect, but the more obvious the rebound after discontinuation.

Tao Yong, an ophthalmologist at Beijing Chaoyang Hospital affiliated to Capital Medical University, said in an interview with upstream news reporters that so far, atropine eye drops are still the only drug that has been proven by evidence-based medicine to effectively delay the progression of myopia.

Tao Yong introduced that in recent years, there have indeed been controversies in the academic community about the clinical safety and efficacy of the eye drops. The control effect of atropine myopia is concentration-dependent, and high-concentration atropine eye drops have adverse reactions such as severe photophobia, decreased near vision and rebound effect of drug withdrawal, and atropine has the potential risk of complications such as glaucoma, and the mainland is very strict in controlling the use of atropine eye drops.

The clinical application of atropine began decades ago, and a number of clinical studies have shown that 1% atropine can effectively delay the development of myopia, but there may be obvious adverse reactions such as mydriasis, photophobia, blurred vision, allergic conjunctivitis, and affecting regulatory function. Therefore, at present, it is generally recommended to use low-concentration atropine, that is, 0.01% atropine, and at the same time, before starting to prepare for the use of atropine to prevent and control myopia, it is necessary to go to the hospital for medical optometry, adjustment force examination, and standardize the use under the guidance of a doctor if it is suitable for use.

In addition, for some parents who reported that their children rebounded after stopping the drug, Tao Yong said that there is indeed such a possibility. He said that from the current clinical use experience, atropine eye drops will have a certain rebound effect after discontinuation, which is manifested in the rebound of the growth rate of refraction and axial length. The lower the concentration, the smaller the myopia rebound effect, with 0.01% atropine ophthalmic solution showing the lowest rebound effect. The older the age of drug withdrawal, the lower the rate of myopia progression during the drug period, the higher the degree of myopia and the longer the eye axis before the drug, and the smaller the myopia rebound effect after drug withdrawal.

Experts say not every child can use it

Tao Yong emphasized that before helping children control myopia, they should not blindly follow the trend of using atropine. You'll need to take your child to the eye doctor and follow his doctor's instructions.

Tao Yong said that although low-concentration atropine is still the only drug that has been proven by evidence-based medicine to effectively delay the progression of myopia, and has been active in the clinical front line of myopia prevention and control, not every child is suitable for use and needs to use.

According to the current clinical application guidelines, for children over 4 years old who already have myopia, or children whose myopia degree increases by 0.5D per year, or whose axial length increases by more than 0.3mm per year, it can be used standardly. If the child has not yet developed myopia, or the farsightedness reserve is insufficient, you can do more outdoor activities, maintain good eye habits to prevent the occurrence and progression of myopia, and do not blindly follow the trend of using atropine.

Tao Yong said that according to the "Appropriate Technical Guidelines for the Prevention and Control of Myopia in Children and Adolescents" issued by the National Health Commission, low-concentration atropine is the only recommended drug suitable for myopia prevention and control. 

Upstream news reporter Zhang Ying