The FDA issued a complete response letter for SYD-101, citing insufficient evidence of effectiveness despite achieving ...
While the trial met its primary endpoint, the FDA stated in its letter that the application could not be approved in its current form.
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Sydnexis Receives Complete Response Letter from FDA for SYD-101 to Slow Pediatric Myopia Progression
Sydnexis, Inc., ( a biopharmaceutical company focused on pediatric progressive myopia (PPM), today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL ...
The FDA declined to approve SYD-101, a low-dose atropine formulation that would have been the first pharmaceutical treatment ...
Developed by Paris, France-based EssilorLuxottica and made for children as young as 6, the brand-new Stellest lenses slow the ...
Patients with high myopia had less favorable refractive results after LASIK but still had satisfactory short-term outcomes, ...
Pediatric progressive myopia is a growing global public health concern, linked to serious ocular complications including ...
The US Food and Drug Administration (FDA) has now approved the marketing of Essilor Stellest eyeglass lenses. It is now approved as a new treatment option designed to both correct myopia, which is ...
The U.S. Food and Drug Administration has authorized marketing of the first eyeglass lenses in the United States that not only correct nearsightedness in children, they can slow the progression of the ...
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