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.
Ocular Allergy/Inflammation
Inveltys Now Available for Post-Op Ocular Pain, Inflammation
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.
Dextenza Approved for Ocular Pain Following Ophthalmic Surgery
The approval was based on data from 2 vehicle-controlled Phase 3 trials.
Inveltys Approved for Post-Op Pain, Inflammation After Ocular Surgery
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.
Ophthalmologists Warn About Eye Injury Risk With Fireworks
American Academy of Ophthalmology recommends wearing protective eyewear, keeping safe distance
Treatment for Limbal Stem Cell Deficiency Gets Orphan Drug Designation
GPLSCD01 is an investigational treatment made up of ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Unique Treatment for Ocular Redness Now Available Over-the-Counter
Lumify is the first OTC eye drop to contain low-dose brimonidine, an alpha-2 adrenergic receptor agonist.
Early Age-Related Macular Degeneration Linked to High HDL
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%.
FDA Accepts Durasert NDA for 3-Year Treatment of Posterior Segment Uveitis
The FDA have set a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018 for Durasert.
NDA Submitted for Durasert 3-Year Implant for Posterior Segment Uveitis
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).
