Hope for Glaucoma Patients: Another Domestic Generic Drug Approved for Market

　　【Pharmaceutical Network | Industry Dynamics] Recently, Suzhou Tianlong Pharmacy announced that its developed Travoprost Eye Drops have been officially approved for market launch. This medication is primarily used to lower intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. The company’s newly approved Travoprost Eye Drops are the first in China to be approved under the new Class 4 registration pathway, which is considered equivalent to passing the consistency evaluation. This marks another new product approval for the company, following the approvals of Levofloxacin Eye Drops in 2017 and Sodium Hyaluronate Eye Drops in 2018.
 

Glaucoma has become a leading cause of blindness worldwide. Currently, there are approximately 67 million glaucoma patients globally, and it is projected that by 2020, the number will reach 79.6 million, with a blindness rate of 14%. At present, clinical treatments for glaucoma mainly rely on anti-glaucoma medications, laser therapy, and surgery. Depending on the type and stage of glaucoma, pharmacological treatment is often the first-line approach, which has driven rapid growth in the market for glaucoma therapeutic drugs.
 

Data shows that the global ophthalmic drug market had total sales of approximately USD 23 billion in 2016, with glaucoma medications accounting for about USD 7.1 billion. Among the top 10 drugs in the glaucoma medication market are latanoprost, travoprost, brinzolamide, brimonidine, carteolol, bimatoprost, latanoprost/timolol, methazolamide, levobunolol, and pilocarpine nitrate.
 

Among them, travoprost eye drops is a new product developed by Alcon in the United Kingdom, which received formal FDA approval in September 2006 under the brand name Travatan. In 2004, Alcon's travoprost eye drops entered the Chinese market and was launched under the brand name Suweitang. In October 2014, the CFDA approved the registration of the combination drug travoprost/timolol eye drops, branded as Sulitan (DuoTrav), which has since entered the domestic hospital market.
 

It is understood that travoprost is an isopropyl ester prodrug. It is absorbed through the cornea and hydrolyzed into its biologically active free acid form. During systemic metabolism, travoprost free acid undergoes oxidative metabolism to form inactive metabolites. By fully activating the FP receptor, it promotes adequate outflow of aqueous humor, thereby providing a potent intraocular pressure-lowering effect and preserving patients’ visual fields. It is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
 

According to Alcon’s data, global sales of its product Xalatan amounted to approximately US$619 million in 2016. Data from Menet shows that total sales of ophthalmic drugs in China reached around RMB 20 billion in 2016, with medications for glaucoma treatment accounting for approximately 11% to 12% of this total. Among these, travoprost-based products represented more than 55%, indicating a market dominated by Alcon’s Xalatan.
 

In recent years, as the National Medical Products Administration (NMPA) has expanded the green channel for drug evaluation and approval, the approval process for registration certificates has also accelerated. In October 2017, Grand Pharma announced that its independently developed "Travoprost Eye Drops," the first generic drug in China for the treatment of glaucoma, had received the New Drug Certificate and Production Approval from the NMPA.
 

With the official approval and market launch of travoprost eye drops by Suzhou Tianlong Pharmacy, it is a great boon for glaucoma patients in China.
 

It is reported that prior to 2020, Suzhou Tianlong Pharmacy primarily focused on high-end generic drugs for anti-infective and dry eye indications. Since 2020, the company has shifted its focus to novel ophthalmic drugs combining imitation and innovation, gradually introducing new dosage forms such as drug delivery systems. Meanwhile, the company is paying close attention to the broader field of ophthalmic health, launching eye care products and health supplements at appropriate times. Through product innovation and collaborations with advantageous enterprises, the company aims to transform into a technologically advanced, specialized, and large-scale ophthalmic pharmaceutical enterprise. The plan is to build the company into a major domestic manufacturer of ophthalmic medications within 5–8 years, establishing strong brand influence in niche ophthalmic market segments.