At the just-concluded National People’s Congress, many representatives of the medical and health put forward suggestions and topics related to fundus diseases. Coincidentally, in the “14th Five-Year Plan” National Eye Health Plan (2021-2025) promulgated last year, fundus diseases were put on the national strategy for the first time, and eye health was regarded as a key task to improve the “National Health Level”.
The current situation of eye health in China is indeed severe, and China is the country with the most eye diseases in the world. With the development of China’s aging trend, the number of patients with cataract, glaucoma, and dry eye disease is on the rise, and the age of patients with retinopathy caused by high blood pressure and high blood sugar is gradually getting younger. Myopia is the most common eye disease. Currently, the number of myopia patients in China has exceeded 600 million, and the myopia rate is as high as 48.5%. In addition, myopia rate among teenagers is even more than 50%.
Ophthalmic drug R&D platform
Medicilon’s preclinical ophthalmic research platform is one experienced team integrating advanced drug delivery technology and analysis methodology.
Development Status of Ophthalmic Drug Market
Facing the hot topic of ophthalmology, the development of ophthalmic drugs in China is rapid, but it is still unable to meet the needs of the market. According to data, the size of China’s ophthalmic drug market has grown from US$2.1 billion in 2015 to US$2.8 billion in 2019, with a growth rate of 8%, which is far exceeding the global growth rate. The growth rate of China ophthalmic drugs will continue to grow, and the growth rate is expected to reach 19.1% in 2030. As a result, the Chinese ophthalmic drug market will reach to US$16.9 billion.
In order to fulfill the market demand for ophthalmic drugs as soon as possible, ophthalmic drugs have been continuously approved recently in China., A lot of pharmaceutical companies have joined the R&D and production of ophthalmic drugs. According to the PharnexCloud database, since 2014, there have been 234 new ophthalmic drugs in China, including 15 drugs in the drug discovery stage and 61 drugs in the preclinical stage. In terms of clinical trial stage, the number of products in phase II clinical trial is 47, which is the largest among the clinical trial stage.
Dosage Form Classification of Ophthalmic Drugs
However, due to the slow progress of research on ophthalmic diseases, China mainly focuses on the development of improved processes or dosage forms of approved drugs in terms of drug research and development. The main dosage forms of eye disease drugs are divided into five categories: eye drops, injections, gels, eye ointments, and tablets. Among them, eye drops have long dominated the ophthalmology market with a wide variety of categories.
| Dosage form | Drug category | Advantage | Disdvantage |
|---|---|---|---|
| Eye drops | Eye drops | The most commonly used ophthalmic dosage forms Easy to administer Remarkable effect | Short duration of action Frequent exposure to ocular side effects |
| Injection | Injection | Immediately inject the effective concentration into the affected area Small doses and conc | Difficult to operate Risk of injury |
| Gel | Eye gel | Good drug absorption high local drug concentration | Blurred vision after use |
| Eye ointment | Eye ointment | Long duration of action Facilitates the healing of corneal injuries | Strong greasy feeling Blurred vision after use |
| Tablet | Eye drops | Suitable for pharmaceutical ingredients with unstable solubility | Cumbersome to use |
Medicilon ophthalmic pharmaceutical preparation services cover four types: eye drops, injections, gels, and eye ointments. Medicilon has completed safety research on the preparations of various eye drops and vitreous injection new drugs and helped to obtain clinical approval.
Injectable ophthalmic drugs encounter greater obstacles in the research and development stage than other dosage forms due to the difficulty of their administration methods. Medicilon’s preclinical ophthalmology research platform can achieve drug administration in animal species such as rabbits, dogs, miniature pigs and non-human primates, including: subretinal injection, suprachoroidal injection, vitreous injection, etc. Medicilon has years of rich practical experience and advanced equipment to solve various complex problems of clients regarding ophthalmology research, focus on details, control quality, and provide clients with stable and high-quality research services.
Development Direction of Ophthalmic Drugs
VEGF Target
VEGF is the most studied target in the development of ophthalmic drugs. Anti-VEGF drugs could reduce the formation of new blood vessels and reduce the permeability of blood vessels. In the global ophthalmic drug market, since anti-VEGF drugs can effectively inhibit the formation of new blood vessels and promote the regression of existing new blood vessels, it has become a first-line therapy for fundus vascular diseases such as wet age-related macular degeneration (wet-AMD), diabetic retinopathy (DR), diabetic macular edema (DME) and retinal vein occlusion (RVO).
Regardless of the world or China, the market competition for the development of anti-VEGF ophthalmic drugs is fierce. According to the white paper of PharnexCloud ophthalmology industry, there are 105 approved ophthalmic drugs worldwide, including 24 approved ophthalmic drugs in China.
On September 19, 2022, Innovent’s self-developed anti-VEGF-A/VEGF-C bispecific antibody IBI333 was approved for clinical use in China, and the indication is neovascular age-related macular degeneration (nAMD). This is also the world’s first clinically approved anti-VEGF-A/VEGF-C bispecific antibody.
In addition, there are two anti-VEGFR ophthalmic drugs in the pipeline of Innovent Bio that have entered the clinical stage, IBI324 (anti-VEGF/Ang2 bispecific antibody) and IBI302 (VEGF/Complement), which are in the leading position in the China VEGF target.
Gene Therapy
Inherited Retinal Disorders (IRDs)
Since most disease-causing genetic mutations have been identified, the fastest-growing indication area for gene therapy is ophthalmology.
Among them, AAV virus vector is the main application. Clinical trials have shown that the use of adeno-associated virus (AAV) vectors to deliver gene therapy in the eye can achieve the effect of treating a variety of genetic eye diseases without causing significant immune responses and systemic side effects.
In December 2017, the first gene therapy was born in the ophthalmic drug market – Luxturna developed by Spark was approved for launching to the market. Three years later, the first in vivo gene therapy product developed by China, NR082 (rAAV2-ND4) developed by Neurophth, was certified as an orphan drug by the US FDA, and was approved to conduct clinical trials in China in March 2021.
According to the latest news, on February 22 2023, NR082 has completed phase III clinical trials in China, and we look forward to the early launch of the first gene therapy ophthalmic drug in China!
