Dry eye drug research and development pipeline is hot: who is the "pioneer"?

Dry eye is a chronic ocular surface disease caused by multiple factors, which may be accompanied by ocular surface inflammation, tissue damage and neurological abnormalities, resulting in various ocular discomfort symptoms and/or visual dysfunction
.
According to reports, the worldwide prevalence of dry eye is 5% to 34%
.
Datamonitor Healthcare reported that in 2020, there were 1.
52 billion dry eye cases in individuals over the age of 15 globally, and this number is expected to increase to 1.
72 billion by 2029
.
Overall Impression Sales will peak in 2023-2024 According to reports, the global sales of dry eye products in more than 70 major pharmaceutical markets in 2020 will be approximately US$5.
24 billion, with a compound annual growth rate of 8.
1% in 2016-2020
.
Global sales of dry eye products are forecast to peak at US$5.
80 billion in 2023-2024 and US$5.
51 billion in 2030
.
The United States is the world's largest market for dry eye products, with a market size of US$3.
02 billion in 2020, and a CAGR of 10.
2% from 2016 to 2020
.
Japan ranks second at $360 million, with a CAGR of -1.
5% from 2016-2020
.
South Korea ranks third with a market size of US$220 million and a CAGR of 11.
7% from 2016 to 2020
.
According to the data of Minet, in 2020, the total sales of domestic dry eye medicine public hospitals and retail pharmacies will be 3.
09 billion yuan, and the compound annual growth rate from 2016 to 2020 will be 6.
4%
.
Affected by the new crown pneumonia epidemic in 2020, the use of dry eye medication in domestic public hospitals decreased by 5.
6% year-on-year, but retail pharmacies increased by 5.
7% year-on-year
.
The sales of cyclosporine in the global market topped the list of active ingredients in dry eye products.
In 2020, the sales of cyclosporine ophthalmic preparations in the world's major pharmaceutical markets topped the list, with sales reaching US$2.
42 billion, with a CAGR from 2016 to 2020.
rate of 7.
1%
.
The first brand of cyclosporine ophthalmic preparations for dry eye disease is Restasis of Allergan, with global sales of US$2.
28 billion in 2020, a compound annual growth rate of 6.
1% from 2016 to 2020, and is forecast to decline to 6.
6% in 2030.
billion dollars
.
Sodium hyaluronate ophthalmic preparations take the lead in the domestic market.
According to the data of Minet.
com, according to the statistics of active ingredients, the sales of dry eye medicine in domestic public hospitals in 2020 will be 2.
32 billion yuan, and the sales of retail pharmacies will be 780 million yuan
.
Among them, the sales of sodium hyaluronate ophthalmic preparations ranked first in domestic public hospitals and retail pharmacy channels, with 1.
20 billion yuan and 290 million yuan respectively, with a compound annual growth rate of more than 15.
0% from 2016 to 2020
.
The first brand of dry eye drug sales in domestic public hospitals is URSAPHARM's sodium hyaluronate eye drops, with sales of 480 million yuan in 2020; Santian's Aili sodium hyaluronate eye drops followed closely with sales The amount is very close to Hailu
.
The No.
1 brand of dry eye drug sales in retail pharmacies is Ruizhu polyvinyl alcohol eye drops of Hubei Yuanda Tiantianming Pharmaceutical, with sales of 210 million yuan in 2020
.
Potential species Which species deserve attention? According to reports, more than 20 drugs have been marketed for the treatment of dry eye in the world, of which 23 are currently in phase III clinical trials and 44 are in phase II clinical trials
.
The varieties worthy of attention are as follows: Loteprednol Suspension Eye Drops On October 26, 2020, the US FDA approved Kala Pharmaceuticals' Loteprednol Suspension Eye Drops (trade name: Eysuvis, 0.
25%), with Short-term (two-week) treatment for the signs and symptoms of dry eye
.
Previously, the US FDA has not approved corticosteroids for the treatment of dry eye, and this product uses Kala Pharmaceuticals' AMPPLIFY mucus penetrating particle (MPP) delivery technology to enhance the penetration of corticosteroids on the ocular surface
.
Varenicline Nasal Spray Created by Oyster Point, this product has multi-targeted action: nicotinic acetylcholine receptor modulator; nicotinic ACh receptor alpha 4 subunit modulator; nicotinic acetylcholine receptor partial agonist; nicotine Acetylcholine receptor beta2 subunit modulator
.
In December 2020, a New Drug Application (NDA) was submitted to the U.
S.
FDA through the 505(b)(2) pathway for the treatment of dry eye signs and symptoms
.
The FDA accepted the application in March 2021, with projected 2030 sales of $500 million
.
Tavilermide is being developed by Mimetogen Pharmaceuticals under the code MIM-D3
.
Tavermide is a small molecule nerve growth factor (Nerve Growth Factor, NGF) mimetic peptide, tropomyosin-related kinase a (TrkA) receptor agonist, mucin secretagogue, 1% eye drops For the treatment of dry eye syndrome (keratoconjunctivitis sicca, dry eye)
.
In October 2013, the dry eye syndrome III clinical trial was initiated; in March 2019, another dry eye syndrome phase III clinical trial was initiated
.
AR-15512 This product was developed by Aerie Pharmaceuticals after the acquisition of AVX Pharma.
It is a transient receptor potential TRPM8 agonist eye drop that selectively acts on temperature or humidity-detecting neurons in the cornea, thereby regulating basal tear fluid to produce a stable tear film , and has analgesic effect, relieve eye discomfort, for the treatment of dry eye (dry eye syndrome)
.
The product has achieved positive results in the Phase IIb COMET-1 clinical trial: it has a statistically significant improvement in various ocular symptoms and signs
.
In November 2020, a phase III clinical trial was initiated in patients with dry eye disease
.
There are many varieties and targets under development.
With the increasing demand for video terminal work, especially people's dependence on mobile phones in daily life and work, the bad habit of excessively looking at mobile phones, as well as diabetes, corneal refractive surgery, pterygium, Allergic conjunctivitis, Sjögren's syndrome and ocular surface drug abuse are all high risk factors for dry eye syndrome
.
The global prevalence of dry eye disease is increasing year by year
.
Because the causes of dry eye syndrome are very complex, the cause of many patients is usually difficult to find.
For these patients, relieving dry eye symptoms is an important goal of their drug treatment.
Therefore, eye lubricants/artificial tears are the current domestic and foreign drugs for dry eye syndrome.
main species
.
The future direction of development is individualized treatment for specific etiologies
.
There is an unmet clinical need for dry eye drugs in the world, and there is a driving force for drug research and development.
The new chemical entities approved for the treatment of dry eye in recent years have clear pharmacological activities
.
The pipeline varieties under research show the characteristics of acting on multiple targets, many varieties and fierce competition.
It is foreseeable that the dry eye drug market will have continuous growth potential in the future
.