Grand Pharma submitted a New Drug Application (NDA) for the global innovative ophthalmic product GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%) to the National Medical Products Administration of the People’s Republic of China (NMPA) which is indicated for the treatment of Demodex blepharitis and got formally accepted recently. It is another significant progress of the innovative field of ophthalmic treatment of the Group.
Demodex mites are the root cause of Demodex blepharitis. GPN01768 is a non-competitive antagonist selective for insect and arachnid gamma-aminobutyric acid-gated chloride channels (GABA-Cl). By selectively inhibiting GABA-Cl in Demodex mites, GPN01768 paralyzes and kills the mites, thereby treating Demodex blepharitis. In addition, GPN01768 is highly lipophilic, which promotes its absorption into the oils of eyelash follicles where mites reside.
GPN01768 was developed by Tarsus Pharmaceuticals, Inc. “Tarsus) and is the first and only product approved by the United States Food and Drug Administration (FDA) for the treatment of Demodex blepharitis. In March 2024, the Group has entered into a strategic cooperation agreement for product introduction with Tarsus, and acquired from LianBio Development (HK) Limited the exclusive development, production and commercialization rights in Greater China Region (Mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China, and Taiwan Region, the Licensed Region) for GPN01768 in treating Demodex blepharitis and Meibomian Gland Disease. This registration progress will, if approved, promote the implementation of GPN01768 in China to benefit patients with Demodex blepharitis as soon as possible.
Blepharitis is a common ophthalmic disease that is characterized by eyelid margin inflammation. Demodex blepharitis is a chronic inflammatory reaction caused by Demodex infestation of the eyelid margin, which accounts for over two-thirds of all blepharitis cases, mainly involving the eyelid skin, eyelash follicles and glands and meibomian glands.
