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Kala submits investigational new drug application
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Kala Pharmaceuticals has submitted an investigational new drug application to the U.S. Food and Drug Administration for a mucus-penetrating particle formulated loteprednol etabonate ophthalmic nano-suspension drug to treat inflammation and pain after cataract surgery, according to a press release.
The company’s mucus-penetrating particle technology platform allows therapeutic agents to pass through the mucus layer of the ocular surface, resulting in penetration into deeper eye tissues, including the aqueous humor and retina, according to the release.
Kala intends to initiate a phase 3 clinical trial to demonstrate anti-inflammatory efficacy similar to that of other steroid-based treatments with less frequent dosing while maintaining the safety profile of other loteprednol etabonate products, the release said.