To advance into the ophthalmic drug market, BRIM Biotechnology Chairman Andrew Lin stated on the 2nd that the company is promoting clinical trials for four new ophthalmic drug candidates this year. Among them, three have entered Phase II clinical trials. The most closely watched candidate, BRM421 for dry eye disease, has completed an improved formulation and will prioritize a dose-response clinical study with the new version. BRIM plans to submit an application for a second Phase III clinical trial in the U.S. in the second half of the year.
BRIM CEO Hsu Wen-chi noted that BRM421 has undergone optimization in both formulation and concentration. In May, the company submitted an application to the U.S. Food and Drug Administration (FDA) for a dose-response human clinical trial, which will determine the optimal dosage for the new formulation.
Simultaneously, BRIM is preparing the application for a second Phase III clinical trial in the U.S., targeted for submission in the second half of this year. The trial design will draw on early findings from the dose-response study to help select and adjust the most suitable dosage, thereby optimizing trial implementation and minimizing development risk.
The company’s second drug, BRM424, developed for the treatment of neurotrophic keratitis (NK), has launched clinical trials across five centers in the U.S. and Brazil. Due to the challenges in recruiting patients for this rare disease, the second patient in the U.S. trial has just been enrolled. Meanwhile, Brazil's National Health Surveillance Agency (ANVISA) approved the trial application in February, and recruitment is expected to begin in June.
To accelerate patient enrollment for this rare disease, BRIM is also expanding its network of clinical trial sites in the U.S. The company hopes these efforts will speed up trial progress and bring better treatment options to patients. Positive clinical data are anticipated by the end of this year.
BRIM's third drug, BRM411, a glaucoma treatment licensed from the Industrial Technology Research Institute (ITRI) last year, has completed formulation optimization. The company has submitted an Investigational New Drug (IND) application to Taiwan’s TFDA for a Phase I/IIb clinical trial and is currently supplementing the application per TFDA’s recommendations.
According to Hsu, the company is actively preparing relevant trial data and advancing clinical planning in parallel to avoid delays. Once the TFDA review is completed, patient enrollment is expected to begin in the second half of the year.
Hsu added that glaucoma is one of the fastest-growing eye diseases and the second leading cause of blindness worldwide. With its potential to reduce side effects like eye redness, BRM411 has attracted interest from several pharmaceutical companies. Alongside clinical development, BRIM has also initiated licensing discussions, aiming to accelerate the development of this next-generation glaucoma therapy through strategic partnerships.
BRIM's fourth pipeline drug, BRM412—also licensed from ITRI—is a new formulation for treating wet age-related macular degeneration (AMD). Following formulation optimization and in-depth analysis of clinical development strategy, the company has held multiple discussions with domestic and international ophthalmology key opinion leaders (KOLs). BRIM plans to request a pre-IND meeting with the U.S. FDA in the second half of this year, followed by a formal Phase II trial application.
Hsu emphasized that BRIM remains committed to professionalism and rigor in advancing innovative drug development and application. To strengthen competitiveness in the biotech sector and ensure sustainable growth, the company continues to explore strategic collaborations, licensing opportunities, and acquisitions—aiming to deliver breakthrough treatment options and meet market and societal expectations for biotech innovation.
Resource: 全福四項眼科新藥推進臨床試驗 今年底將有數據成果
