Recently, Guangdong Provincial People's Hospital successfully completed the injection of the innovative drug Busiliximab, which is also the first batch of injection of this drug in public hospitals in mainland China. Relying on the "Hong Kong-Macau Pharmaceutical and Device Access" policy, Busiliximab has been approved for urgent clinical use in designated medical institutions in the Greater Bay Area. This new generation of anti-VEGF (vascular endothelial growth factor) drugs in public hospitals will enhance the accessibility of innovative therapies and benefit more patients with fundus diseases.

China has more than 40 million patients with endophthalmic disease, and is in urgent need of new drugs to break through the treatment dilemma.

The number of patients with fundus diseases in China is increasing, with the potential number of patients with fundus diseases reaching 40 million. The most common of them are diabetic retinopathy and age-related macular degeneration, in addition to many other types of fundus diseases, which have a great impact on patients' health and quality of life, such as affecting vision, triggering ocular discomfort and increasing mental stress.

With the aging of the population and changes in people's lifestyles, the problems of age-related eye diseases and metabolic-related eye diseases have become more and more prominent, and fundus diseases have become the main blinding eye diseases in China. At present, more than 3 million new patients with fundopathy are admitted to hospitals every year in China, but the correct treatment rate is less than 10%, of which, more than 50% of the patients' age distribution is between 40 and 60 years old. According to statistics, the prevalence of diabetes mellitus in China reaches 9.7%, and the prevalence of pre-diabetes is as high as 15.5%. Diabetic macular edema (DME), as a common ocular complication in diabetic patients, is also the main cause of visual function impairment in diabetic patients. It is estimated that there are more than 5.7 million cases of DME in China.

Currently, vitreous injection of anti-VEGF drugs is the mainstream treatment for DME, and many patients have benefited from the rapid improvement of vision after injection of anti-VEGF drugs. However, a significant portion of patients with fundopathy have more complex conditions, which are not sensitive to the response of primary anti-VEGF drugs, and some patients with severe lesions need repeated injections. Studies have shown that existing anti-VEGF drug therapy can only effectively reduce edema and improve visual acuity in about 50% of patients, and the clinical needs of DME patients have not yet been adequately met, and there is an urgent need for the introduction of innovative drugs with better efficacy, longer dosing intervals, and higher compliance.

Buxibacizumab is now available in public hospitals, benefiting more patients with fundus disease.

Benefiting from the preferential policy of early and pilot implementation in Guangdong, Hong Kong and Macau, the new generation of anti-VEGF drug Busilixizumab completed its first batch of public hospital injections in Guangdong Provincial People's Hospital (GDPH) in May 2024, which was carried out by Prof. Yu Honghua, Director of Ophthalmology, Guangdong Provincial People's Hospital (GDPH).

Patients with diabetic macular edema face many challenges in terms of adherence and accessibility to disease treatment. Clinical evidence shows that bucizumab has the advantages of smaller molecular weight, faster onset of action, greater ability to reduce retinal edema, and longer treatment intervals than existing treatments, which is expected to significantly improve patients' clinical benefits and medication adherence. We look forward to the approval of buxibacizumab and its wide application nationwide, so that this innovative therapy can benefit more patients.
--- Prof. Yu Honghua, Director of Ophthalmology, Guangdong Provincial People's Hospital, China

Sprinting to the fast lane of accessibility to accelerate the benefits to patients with fundus diseases

With the continuous support of a series of national policies, the clinical application of busiliximab in China is progressing. Prior to this, the drug has been applied in Boao LeCheng International Medical Tourism Pioneer Zone in Hainan and other places to carry out pilot clinical applications, and achieved excellent clinical results, which provides strong evidence of the innovative value of buxibacizumab and is expected to help accelerate the approval and accessibility of the drug.

At the 2024 meeting of the Association for Research in Vision and Ophthalmology (ARVO), Novartis announced the 54-week results of the CONDOR Phase III clinical trial of buxibizumab 6mg for the treatment of proliferative diabetic retinopathy (PDR). The results showed that buclizumab was significantly superior to conventional whole retina laser photocoagulation (PRP) therapy in maintaining best-corrected visual acuity, reducing macular edema, and controlling the progression of diabetic retinopathy, while showing no additional safety risks. This is the world's first PDR Phase III registry study in a Chinese population, marking an important advance in the treatment of diabetic retinopathy.

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