Opus Genetics Inc（IRD）资讯与事件IRDOpus Genetics Inc

Opus Genetics Receives FDA Approval for Presbyopia Drug

Opus Genetics (IRD) announced that the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults. Opus Genetics and Viatris (VTRS) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize the product in the United States. This FDA approval in presbyopia will trigger a milestone payment to Opus Genetics. The FDA approval is supported by positive results from the pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials, both of which met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported. Phentolamine ophthalmic solution 0.75% is a preservative-free, topical formulation that reduces pupil diameter through a sympatholytic mechanism of action, without engaging the ciliary muscle.

Opus Genetics Presents Clinical Findings for OPGx-BEST1 and OPGx-LCA5 in Brazil

Opus Genetics presented clinical findings from its OPGx-BEST1 and OPGx-LCA5 gene therapy programs at Retina in Rio 2026 in Rio de Janeiro, Brazil. The company presented findings from the low-dose Cohort 1 of its Phase 1/2 BIRD-1 trial of OPGx-BEST1, which showed improved retinal sensitivity in three of four evaluable participants. Additional analyses identified retinal structural and imaging characteristics associated with visual function and treatment response, providing insights that may help guide future clinical development. Additional findings from the ongoing Phase 1/2 trial of OPGx-BEST1 demonstrated encouraging improvements in retinal sensitivity in participants with BEST1-associated retinal diseases, along with new insights into imaging markers that may help predict treatment response. The company also presented findings from the Phase 1/2 clinical trial of OPGx-LCA5, which demonstrated sustained improvements in visual function among adults and children treated with OPGx-LCA5 for Leber congenital amaurosis type 5, or LCA5, a rare inherited retinal disease that causes severe vision loss beginning in childhood. In the OPGx-LCA5 Phase 1/2 study, improvements in visual acuity and light sensitivity were observed in three adult participants through 24 months and three pediatric participants through six months. Participants also reported improvements in everyday activities, including navigating independently, recognizing family members, and identifying objects and seeing colors. Opus presented findings from the ongoing Phase 1/2 BIRD-1 trial of OPGx-BEST1, an investigational gene therapy designed to restore bestrophin-1 function in patients with IRDs caused by mutations in the BEST1 gene, including Best vitelliform macular dystrophy, or BVMD, and autosomal recessive bestrophinopathy, or ARB. The presentation included results from five participants treated in the initial low-dose cohort, with follow-up ranging from three to six months. Among four participants who could complete retinal sensitivity testing, three demonstrated improvements in the treated transitional zone, an area surrounding damaged retinal tissue where light-sensitive cells remain and may be responsive to treatment. Improvements were measured using microperimetry, a test that evaluates the retina's ability to detect light at specific locations. In responding participants, increases in retinal sensitivity were also associated with reductions in intraretinal fluid characteristic of BEST1-associated disease. Additional analyses examined the relationship between retinal structure and function, suggesting that measurements obtained through optical coherence tomography, or OCT, and other imaging techniques may help identify retinal regions most likely to respond to treatment. The presentation also highlighted natural history findings demonstrating that retinal sensitivity declines most noticeably in the transitional zone surrounding damaged tissue, even when measurements across the entire retina appear relatively stable. Together, these findings are informing future clinical development of OPGx-BEST1, including more targeted retinal sensitivity assessments and imaging approaches designed to improve the measurement of treatment response. Rodrigo Jorge of Ribeirao Preto Medical School at the University of Sao Paulo, presented findings from the ongoing Phase 1/2/3 trial of OPGx-LCA5, an investigational gene therapy designed to restore production of lebercilin, a protein essential for normal retinal function. The presentation included data from six participants treated at the low dose of 1E10 vector genomes per eye, including three adults and three adolescents. Adults demonstrated sustained improvements in visual acuity through 24 months, while pediatric participants demonstrated restoration of cone-mediated vision with sensitivity improvements reaching normal ranges through six months. Both groups also demonstrated improved light sensitivity, as measured by full-field stimulus testing, or FST, compared with their untreated eyes. Additional retinal imaging using microperimetry showed increased retinal sensitivity and movement of visual fixation toward the central retina, which is responsible for sharp, detailed vision. Participants also reported meaningful improvements in everyday activities, including recognizing family members, navigating independently without a cane, identifying objects and participating in activities that had previously been difficult because of severe vision loss. Based on the encouraging Phase 1/2 findings, Opus advanced OPGx-LCA5 into Phase 3 development using the low dose without requiring further dose escalation. The Phase 3 clinical trial's natural history and treatment cohorts are fully enrolled, with dosing initiation expected in the fourth quarter of 2026. The clinical trial's primary efficacy endpoint will assess improvements in retinal sensitivity across 16 central retinal test locations. OPGx-LCA5 is an investigational adeno-associated virus serotype 8, or AAV8-based gene therapy designed to deliver a functional copy of the LCA5 gene to retinal photoreceptors. Mutations in LCA5 disrupt production of lebercilin, a protein critical for normal retinal function, resulting in severe visual impairment beginning early in life.

Major Averages Decline for Second Day as Treasury Yields and Oil Prices Rise

The major averages moved lower for a second day in a row as Treasury yields and oil prices continue to climb. Treasury yields jumped after the U.S. Treasury Department said it will triple its buyback operation of longer-dated government debt to $6B.The renewed oil spike, meanwhile, is being driven by escalating fighting in the Middle East, including attacks involving Iran-backed Houthi militants and Saudi energy infrastructure. Brent has gained roughly 20% over the past month, raising concerns that an extended energy shock could feed directly into consumer inflation and complicate the Federal Reserve's policy decision next week.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Independence Realty Trustand Centerspacein an $8.1B all-stock combinationAnalog DevicesAlif Semiconductor for $1.35B in cashJersey Mike's Subsreportedin its first quarterly report as a public companyChimeStride Bank for $590M in cash and raised its Q3 and FY26 revenue outlooksDuring a live-streamed event, Appleunveiled its new, as well as the iPhone 18 Pro, AirPods 5, and two new Apple Watches2. WALL STREET CALLS:Thermo Fisherto Buy at UBSDyne Therapeuticsto Underweight at JPMorganLineageto Overweight at Morgan StanleyMartin Mariettato Overweight at Wells FargoVulcan Materialsto Underweight at Wells Fargo3. AROUND THE WEB:UnitedHealthis selling a stake in Optum Health to TPGoperations as it works to restructure and stabilize the underperforming division following a major profit decline, Bloomberg reportsBP'sNorth Sea operations have drawn interest from suitors including Adura and NEO Next+, Bloomberg saysAs part of efforts to reshape its portfolio amid a prolonged downturn in the industry, Dowis considering plans to exit its $20B chemicals partnership with Saudi Aramco, Bloomberg reportsParamount Skydanceis arguing that California AG Rob Bonta's public comments undermine his legal opposition to Paramount's $1.88B bond request, potentially strengthening its position as it seeks protection against costs from the state-led challenge to its Warner Bros. Discoverymerger, Reuters saysThe U.S. Justice Department is expanding its antitrust probe into Fox'sproposed $22B takeover of Roku, Semafor reports4. MOVERS:Opus Geneticsgained afterof its BIRD-1 trialSignet Jewelersincreased in New York after, providing guidance for Q3, and raising its outlook for FY27Compass Pathwayswas higher in New York afterfrom its Phase 3 COMP005 trialServiceTitanfell afterand appointing Pretorius as its next chief revenue officerTyra Bioscienceswas lower after reporting results from its5. EARNINGS/GUIDANCE:Academy Sportsand raised its outlook for FY26Core & Main, with CEO Mark Witkowski commenting that "momentum continues to build across the business"Chewy, provided guidance for Q3, and raised its outlook for FY26Sunbelt Rentals, with EPS and revenue beating consensusCognyte, with CEO Elad Sharon calling it "a strong quarter"INDEXES:The Dow fell 405.41, or 0.77%, to 52,380.66, the Nasdaq lost 168.07, or 0.64%, to 26,253.34, and the S&P 500 declined 37.16, or 0.48%, to 7,636.36.