Taiwan’s BRIM Biotechnology to advance clinical trials for 4 new eye drugs
台灣全福生物科技將推動四種新型眼科藥物的臨床試驗
Company says new drugs target dry eye, glaucoma, keratitis, and macular degeneration
TAIPEI (Taiwan News) — BRIM Biotechnology Chair Lin Chun (林羣) said the company will advance clinical trials for four new eye drugs this year.
Lin said BRIM Biotechnology’s new dry eye treatment, BRM421, has completed formulation and concentration optimization. The company submitted a human clinical trial application for the drug to the US Food and Drug Administration in May, per CNA.
BRIM Biotechnology also plans to submit documentation for a second Phase III clinical trial of BRM421 to US authorities in the second half of this year. The trial design will incorporate data from earlier human studies to refine dosage levels.
The company's other new drug, BRM424, developed to treat neurotrophic keratitis, a degenerative corneal disease caused by impaired sensory innervation, has begun clinical trials in the US and Brazil. A second patient in the US trial has been enrolled. Meanwhile, Brazil's national health authority has approved the human clinical trial, with enrollment scheduled for this month.
In collaboration with the Industrial Technology Research Institute, the company completed formulation improvements for its glaucoma treatment candidate, BRM411. Lin said the firm applied to Taiwan’s Food and Drug Administration to begin human clinical trials.
BRIM Biotechnology General Manager Hsu Wen-chi (徐文祺) said that glaucoma, an eye condition that damages the optic nerve, is rapidly increasing in Taiwan and is the second leading cause of blindness in the country. She noted that BRM411 can potentially reduce side effects and has attracted interest from pharmaceutical companies.
The company also cooperated with ITRI to develop BRM412, a new drug candidate for treating macular degeneration, an eye disease that can blur a patient's central vision. Hsu said the company has improved the drug’s formulation. She added that an application for a Phase II clinical trial for the medicine will be submitted to the US FDA in the second half of this year.
According to the International Myopia Institute, more than 73% of Taiwan's population is affected by myopia. High myopia can lead to complications such as cataracts, retinal detachment, macular degeneration, and even blindness.
As of March 2024, more than 450,000 individuals in Taiwan were diagnosed with glaucoma, a 22% increase over the past five years. Macular degeneration affects approximately 10% of the nation's population aged 65 and older.