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Veligrotug Delivers Positive Results in Phase 3 TED Trial
Viridian Therapeutics has announced positive topline results from the Phase 3 THRIVE-2 clinical trial evaluating veligrotug, an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, for the treatment of chronic thyroid eye disease (TED). The trial met its primary and secondary endpoints,…
EMA Backs Celltrion’s Aflibercept Biosimilar
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and marketing authorization recommendation for Eydenzelt, Celltrion’s biosimilar to aflibercept (Eylea). This marks a significant milestone for Celltrion, a South Korea-based biopharmaceutical…
HORA-PDE6b Gets FDA Rare Pediatric Disease Status
eyeDNA Therapeutics, a newly created subsidiary of Coave Therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) for HORA-PDE6b, the company’s novel gene therapy designed to treat inherited retinal dystrophy…
FDA Approves SB-007 for Stargardt Disease
The FDA has cleared an Investigational New Drug (IND) application for SB-007, an adeno-associated viral (AAV) vector gene therapy targeting the root genetic cause of Stargardt disease, according to a press release from SpliceBio. Addressing Stargardt Disease Across All ABCA4…
Atsena Completes XLRS Gene Therapy Trial Dosing
Atsena Therapeutics has successfully completed dosing in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating the subretinal delivery of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). The study represents an important step forward in developing…
ACELYRIN Halts Izokibep Development | OBN
ACELYRIN has announced that the Phase 2b/3 clinical trial evaluating izokibep for non-infectious, non-anterior uveitis did not achieve its primary endpoint. The trial results did not demonstrate a statistically significant improvement in time to treatment failure versus placebo. Consequently, the…
Fluoxetine Improves Visual Acuity in Adult Amblyopia
A groundbreaking study conducted by researchers from the Eye Research Center, Farabi Eye Hospital, and Tehran University of Medical Sciences has revealed that fluoxetine, a commonly used antidepressant, significantly improves visual acuity (VA) in adults with amblyopia. The study, led…
Stem Cell Breakthrough Restores Vision in LSCD Patients
In a groundbreaking achievement, researchers from Osaka University in Japan have successfully conducted the first human trial using induced pluripotent stem-cell-derived corneal epithelium to treat limbal stem cell deficiency (LSCD). This innovative approach marks a significant advancement in vision restoration…
Bimekizumab Reduces Uveitis Incidence in axSpA Patients
The study led by Matthew A. Brown, Genomics England, London, United Kingdom, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Bielefeld, Germany. Patients with axial spondyloarthritis (axSpA) treated with bimekizumab exhibited a markedly lower incidence of uveitis compared to those receiving…
ANX007 Protects Vision in Dry AMD – AAO 2024
A new investigational drug, ANX007, offers hope for the millions of people suffering from geographic atrophy, a severe form of dry age-related macular degeneration (AMD). The drug’s potential to reduce vision loss and protect essential retinal structures was highlighted at…