BRIM Biotechnology's new dry eye drug BRM421 has received pre-EOP2 approval from the US FDA for Phase III clinical trial design and the company will apply to conduct a Phase III clinical trial in the US.

The team is also pleased to accept the FDA's recommendations on the implementation of future drug license applications (NDAs), which the team expected and welcomed, and has cancelled the EOP2 meeting scheduled for October 24, 111. The team will apply for a Phase III clinical trial in the US according to the design of the Phase III clinical trial submitted to the US FDA, in order to achieve early launch as a first-line drug for the treatment of dry eye.

BRM421 is a new, novel drug with a new mechanism for the treatment of dry eye. Based on the data from two completed Phase II clinical trials, BRM421 promotes the regeneration and differentiation of ocular cupped stem cells to repair the cornea, inhibit inflammation and promote healing of dry eyes. BRM421 is a novel regenerative therapy that, if approved for marketing, will not only revolutionize the current treatment of dry eye, but will also make Taiwan's original medicine visible to the world.

Dry eye is a common but complex chronic disease. According to GlobalData, the global dry eye drug market in 2018 was approximately US$3.9 billion, but more than half of the listed drugs are anti-inflammatory prescription drugs, while the rest are mostly artificial tears, lubricants and other products, and there is still no effective cure.

Due to the widespread use of 3C products, the long-term use of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has been rising rapidly in recent years and is getting younger. Overseas studies have pointed out that newly recovered patients are at high risk of developing dry eye in the future, and the global dry eye drug market is expected to accelerate and expand.