The FDA has approved acoltremon 0.003% ophthalmic solution (Tryptyr – Alcon) for treatment of dry eye disease. Acoltremon is the first transient receptor potential melastatin 8 (TRPM8) thermoreceptor agonist to be approved in the US for this indication.
DRY EYE DISEASE — Disruption of tear-film homeostasis (altered composition, reduced production, rapid evaporation) and resulting ocular surface inflammation cause the discomfort and blurred vision of dry eye disease. Many cases are caused by tear evaporation due to meibomian gland dysfunction. Other precipitating factors include...
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RELEASE
The FDA has approved Kirsty (Biocon), a biosimilar to rapid-acting insulin aspart (NovoLog), for treatment of type 1 or type 2 diabetes. Kirsty is the first rapid-acting insulin to become available in the US that has received interchangeability status with NovoLog; Merilog, another insulin aspart biosimilar, was approved earlier but has not received interchangeability status with NovoLog.1
REGULATORY STATUS — A biosimilar is a biologic product that is highly similar in composition, strength, and biological properties and has no clinically meaningful differences in efficacy, safety, purity, and potency to the FDA-approved reference product. For a biosimilar to be approved as an interchangeable product, the manufacturer must conduct clinical trials to prove that the results will be the same if the patient switches between the reference product and …