CyclASol is an investigational topical treatment of cyclosporine that contains no oils or surfactants and is preservative-free.
Iheezo is a sterile, preservative-free, single-patient use, ophthalmic gel preparation.
The sBLA is supported by data from a phase 3 trial that evaluated lanadelumab to prevent acute HAE attacks in 21 patients 2 to less than 12 years of age.
Tarcocimab tedromer is an investigational VEGF inhibitor designed to improve bioavailability and intraocular half-life using the Company’s antibody biopolymer conjugate platform.
Pegcetacoplan is a targeted C3 therapy that works by regulating excessive activation of the complement cascade.
The approval was based on data from the phase 2 IMCgp100-202 trial that assessed Kimmtrak in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
Pataday Once Daily Relief Extra Strength is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Refresh Digital is designed to protect tears from evaporating due to incomplete blinking during digital device use.
The NDA submission is supported by data from the phase 3 MIST-1 and MIST-2 studies.
Previously, the device had only been approved in those with episodic migraine.
