Taiwanese firm Brim Biotechnology enrolled its first patients in the phase 3 clinical trial of BRM421, a first-in-class regenerative peptide, which repairs corneal damage and could potentially relieve the symptoms of dry eye disease (DED) in as little as two weeks.
The multicentre, double-blind, randomised, vehicle-controlled US trial will include more than 700 patients with moderate to severe DED. Patients will be treated with BRM421 or control eye drops for two weeks, with evaluation of efficacy and safety on day eight and day 15. Phase 2 data supports the company’s claims of BRM421 healing corneal damage and the rapid resolution of DED symptoms. The phase 3 trial’s co-primary endpoints are total corneal fluorescein staining score on day 15 and the visual analogue score of burning and stinging on day eight, said Dr Wen Chyi Shyu, CEO of Brim. “Due to its unique mechanism of action, BRM421 has the potential to become the first DED treatment to offer rapid and total relief.”
Topline results are expected at the end of 2023.
