OC-01 and OC-02 are two highly selective acetylcholinergic receptor agonists that treat dry eye by initiating the trigeminal parasympathetic pathway and increasing natural tear production.
OC-01 was approved for marketing in the United States in October 2021 and is currently the world’s first and only preservative-free, multi-dose, aseptically packaged nasal spray approved for the treatment of mild, moderate and severe dry eye, and was approved for marketing in November 2024 in China;
OC-02 completed a Phase IIb clinical study in the United States for dry eye, which showed that the product was able to promote tear film production, thereby improving the signs and symptoms of dry eye patients.
Grand Pharma entered into a strategic cooperation agreement for product introduction with Corxel Pharmaceuticals Hong Kong Limited (Corxel). According to the agreement, after the relevant conditions are met, the Group will obtain the exclusive development 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 varenicline tartrate nasal spray (OC-01), the world’s first innovative product for the treatment of dry eye, and OC-02 (Simpinicline) nasal spray (OC-02). This strategic cooperation will further deepen the strategic plan of the Group’s innovative products in the field of ophthalmology.
According to the results of the Phase III clinical study of OC-01, OC-01 showed statistically and clinically significant improvements in tear secretion in patients with dry eye compared with the control group. The natural tear secretion of the subjects increased significantly compared with the baseline (the proportion of subjects whose Schirmer score increased by greater than or equal to 10 mm from baseline was significantly dominant), with favorable safety and tolerability. OC-02 has completed a Phase IIb clinical study for dry eye in the United States. The results showed that the product can increase production of tear film, thereby improving the signs and symptoms of patients with dry eye.
Grand Pharma always regards the field of ophthalmology as one of its important strategic development directions, continuously focus on ophthalmic drug innovation, adheres to the path of professional development, to improved its industry position and market competitiveness constantly. At present, the Group has established a “professional, full-series, multi-variety” innovative drug product system, reserved a few world-wide innovative products for the treatment of “myopia”, “dry eye”, “pterygium”, “anti-inflammatory and analgesic after ophthalmology surgery”, “Demodex blepharitis” and “Demodex blepharitis patients with meibomian gland disease”, and have made significant research and development progress. In the next three years, a number of innovative products are expected to be approved for commercialization.
