Thyroid Eye Disease Treatment Gets FDA’s Priority Review
The FDA has accepted for priority review the Biologics License Application (BLA) for teprotumumab (Horizon Therapeutics) for the treatment of active thyroid eye disease.
The FDA has accepted for priority review the Biologics License Application (BLA) for teprotumumab (Horizon Therapeutics) for the treatment of active thyroid eye disease.
Data from two Phase 3 studies showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation and pain compared with placebo.
The approval was based on data from 2 vehicle-controlled Phase 3 trials.
Data from two Phase 3, multicenter, randomized, double-masked, placebo-controlled trials showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation.
American Academy of Ophthalmology recommends wearing protective eyewear, keeping safe distance
GPLSCD01 is an investigational treatment made up of ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Lumify is the first OTC eye drop to contain low-dose brimonidine, an alpha-2 adrenergic receptor agonist.
The researchers found that the incidence rates of early and advanced AMD were 79.9 and 18.6 per 1,000 person-years, respectively, corresponding to five-years risks of 32.9 and 8.9%.
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).