Opus Genetics (NASDAQ: IRD) has announced the completion of dosing in the higher-dose Cohort 2 of BIRD-1, its ongoing Phase 1/2 clinical trial evaluating OPGx-BEST1 in patients with BEST1-related retinal diseases, including Best vitelliform macular dystrophy (BVMD) and autosomal recessive bestrophinopathy (ARB).
The company expects to report topline three-month data from Cohort 2 in the first quarter of 2027, with dosing in a potential pivotal Phase 3 trial anticipated to begin in the second half of 2027.
In a statement, George Magrath, MD, CEO of Opus Genetics, commented, “Completing dosing in Cohort 2 represents a key step in advancing OPGx-BEST1 toward potential pivotal development. The positive results from Cohort 1, including clinically meaningful improvements in visual function in all five participants and encouraging structural improvements, provide important proof of concept for this program. We expect Cohort 2 data to further characterize the safety, functional, and structural responses to OPGx-BEST1 at the higher dose and inform the design of a potential pivotal trial. We look forward to reporting this additional data in the first quarter of 2027 as we work toward delivering a potential first treatment addressing the underlying genetic cause of BEST1-related retinal diseases.”
