FDA Advisory Committee votes on whether the Pfizer-BioNTech vaccine should be authorized in 5 to 11 year olds; The Moderna vaccine elicits strong antibody responses in pediatrics; Trial results shed light on booster dose efficacy; Shingrix is recommended for immunocompromised patients; A novel treatment is approved for macular edema associated with uveitis; And Pepaxto is withdrawn following new findings.
The approval was based on data from the pivotal phase 3 PEACHTREE trial, the phase 3 MAGNOLIA study, and the open-label safety AZALEA trial.
Difluprednate Ophthalmic Emulsion 0.05% is an AB-rated generic equivalent of Durezol.
Certain types of tumor necrosis factor (TNF) agents may affect the recurrence of uveitis in Behcet disease (BD) patients, while not affecting the occurrence of uveitis in patients with ankylosing spondylitis (AS), according to research presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting.
Control of inflammation not superior with mycophenolate mofetil versus methotrexate
This slideshow reviews drug information for Yutiq. Click here for the complete Yutiq monograph. For a downloadable PDF of this slideshow, click here.
Clearside Biomedical announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Xipere (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis.
EyePoint announced the launch of Yutiq (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The product was approved by the Food and Drug Administration (FDA) in October 2018. Yutiq is a sterile non-bioerodible intravitreal implant containing fluocinolone acetonide 0.18mg in a 36-month sustained-release drug delivery system.…
The FDA have set a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018 for Durasert.
The NDA submission was supported by data from two Phase 3 studies that met the primary efficacy endpoint of prevention of recurrence of uveitis at 6 months of follow-up (P<0.001).
