Once-Daily Eye Drop for IOP Enters FDA Review - Takeaways - MDSpire

Once-Daily Eye Drop for IOP Enters FDA Review

FDA acceptance puts Kowa Pharmaceuticals’ nitric oxide-donating bimatoprost on track for an April 2027 decision

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The FDA has accepted Kowa Pharmaceuticals' NDA for K-911, a once-daily eye drop for lowering intraocular pressure.
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K-911 is designed for patients with open-angle glaucoma or ocular hypertension and utilizes nitric oxide and bimatoprost.
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The FDA has set a target action date of April 30, 2027, for the review of K-911.
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The NDA is supported by two Phase III trials, Mont Blanc and Denali, comparing K-911 to latanoprost.
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K-911 remains investigational and has not yet been approved by the FDA.