Business
Opus Genetics Announces Positive Recommendation from Independent Data Monitoring Committee for Phase 1/2 Trial in Best Disease
Initial favorable safety profile demonstrated in OPGx-BEST1 clinical trialRESEARCH TRIANGLE PARK, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Opus Genetics (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the Independent Data Monitoring Committee (IDMC) issued a positive recommendation to continue as planned in the Comp
About this update from Opus Genetics, Inc.
[{"type":"image","alt":"Opus Genetics, Inc.","displaySize":"","headline":null,"caption":"Opus Genetics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":129,"url":"https://media.zenfs.com/en/globenewswire.com/df50c41a115dee0675cbe3b477dc2db0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/8o4zybgloi24hra3hobbTg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE4MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/df50c41a115dee0675cbe3b477dc2db0","width":300,"height":129}},"lazy":false},{"type":"text","content":"Initial favorable safety profile demonstrated in OPGx-BEST1 clinical trial","length":74,"tagName":"p"},{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Opus Genetics (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the Independent Data Monitoring Committee (IDMC) issued a positive recommendation to continue as planned in the Company’s Phase 1/2 BEST1 clinical trial (BIRD-1), which is a multi-center, adaptive, open-label, dose-exploring study evaluating OPGx-BEST1 in participants with Best disease.","length":597,"tagName":"p"},{"type":"text","content":"The IDMC overseeing the trial completed its pre-specified safety review of the one-month data from the sentinel participant and recommended advancing enrollment and dosing of additional participants in the trial, without modification.","length":234,"tagName":"p"},{"type":"text","content":"“We are thrilled with this outcome from the first participant, whose encouraging safety results at one month enable us to proceed with dosing the next four participants in our BEST1 Phase 1/2 trial,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “The IDMC’s safety review and recommendation to continue the trial reinforces our confidence as we advance this program. BEST1-associated retinal diseases constitute a substantial unmet medical need, and this progress with OPGx-BEST1 represents an important step toward potentially preserving and restoring visual function for patients with Best disease.”","length":622,"tagName":"p"},{"type":"text","content":"About OPGx-BEST1 and the Phase 1/2 Trial","length":40,"tagName":"p"},{"type":"text","conte...