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.
The application is supported by data from the double-blind, placebo-controlled phase 3 VOYAGER PAD trial.
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
The FDA has granted Fast Track designation to Zimura (avacincaptad pegol; Iveric Bio) for the treatment of geographic atrophy secondary to dry age-related macular degeneration.
Cystinosis is a rare, multisystem genetic disorder caused by an accumulation of cystine crystals throughout the body, including the eyes.
The Food and Drug Administration (FDA) has approved Tepezza™ (teprotumumab-trbw; Horizon Therapeutics) for the treatment of thyroid eye disease.
