5 Key Takeaways

• 1

  The FDA has accepted Kowa Pharmaceuticals' NDA for K-911, a once-daily eye drop for lowering intraocular pressure.

• 2

  K-911 is designed for patients with open-angle glaucoma or ocular hypertension and utilizes nitric oxide and bimatoprost.

• 3

  The FDA has set a target action date of April 30, 2027, for the review of K-911.

• 4

  The NDA is supported by two Phase III trials, Mont Blanc and Denali, comparing K-911 to latanoprost.

• 5

  K-911 remains investigational and has not yet been approved by the FDA.