FDA accepts NDA for bimatoprost grenod in open-angle glaucoma and OHT

The FDA has accepted for review the new drug application (NDA) for Kowa Pharmaceuticals America’s K-911 (bimatoprost grenod; also known as NCX 470), an investigational once-daily topical monotherapy for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.¹ The agency assigned a Prescription Drug User Fee Act target action date of April 30, 2027, according to a news release.¹ Additionally, Kowa anticipates a US commercial launch in the second half of 2027, contingent on approval.¹

"The FDA's acceptance of the NDA for K-911 marks an important milestone as we work toward bringing a potential new treatment option to people living with open-angle glaucoma or ocular hypertension," said Joe Barna, CPA, chief executive officer and president of KPA, in the release. "We're proud to bring Kowa's decades of global ophthalmology experience to the US eye care community, and we look forward to working with the FDA throughout the review process."

K-911 is a nitric oxide-donating bimatoprost formulation engineered to lower IOP through 2 distinct aqueous humor outflow pathways. Nitric oxide is intended to enhance conventional outflow through the trabecular meshwork-Schlemm's canal pathway, while bimatoprost enhances uveoscleral outflow. The NDA is supported by 2 pivotal phase 3 trials, Mont Blanc and Denali, which evaluated K-911 0.1% against latanoprost 0.005%, a widely used prostaglandin analog, in patients with open-angle glaucoma or ocular hypertension. Nicox S.A. discovered and developed the agent and led both pivotal trials, and continues to provide development support. Kowa is responsible for US regulatory and commercialization activities under a July 2025 licensing agreement granting rights to develop and commercialize the agent in the US and other licensed territories.¹

The glaucoma and ocular hypertension treatment landscape

Despite the availability of multiple treatment options, achieving and maintaining appropriate IOP control remains an important treatment goal in this population.¹ More than 4.2 million adults in the US live with glaucoma, and open-angle glaucoma represents the most common form.^2,3 An estimated 3 to 6 million people live with ocular hypertension, a condition characterized by elevated IOP without detectable optic nerve damage or vision loss.^4,5 Elevated IOP is an important risk factor for the development of glaucoma.⁴

K-911 remains investigational and has not yet been approved by the FDA. Specific efficacy and safety outcomes from the Mont Blanc and Denali trials were not detailed in the announcement, and full data will inform the eventual product profile if the agent reaches market.¹

For ODs, the dual-pathway mechanism is the notable clinical feature, pairing nitric oxide-driven conventional outflow with prostaglandin-mediated uveoscleral outflow in a single once-daily drop. If approved, the agent would be available for prescribing within state scope and could factor into medical management and comanagement decisions. Optometrists should watch for full phase 3 data comparing the agent with latanoprost to assess where it fits relative to existing prostaglandin analogs.

References

1. Kowa Pharmaceuticals America. FDA accepts for review the NDA for K-911 (bimatoprost grenod) for open-angle glaucoma or ocular hypertension. News release. Kowa Pharmaceuticals America, Inc. 2026. https://www.prnewswire.com/news-releases/kowa-pharmaceuticals-america-announces-fda-acceptance-of-new-drug-application-for-k-911-an-investigational-iop-lowering-eye-drop-for-patients-with-open-angle-glaucoma-or-ocular-hypertension-302861949.html?utm_medium=paid-search&utm_source=bing&utm_campaign=tin_bing_search_us_en_brand_core&utm_content=_brand_core&utm_term=pr%20newswire

2. Glaucoma. Cleveland Clinic. Updated November 12, 2024. Accessed August 27, 2026. https://my.clevelandclinic.org/health/diseases/4212-glaucoma

3. Glaucoma. National Eye Institute. Updated August 19, 2026. Accessed August 27, 2026. https://www.nei.nih.gov/eye-health-information/eye-conditions-and-diseases/glaucoma

4. Ehrlich JR, Burke-Conte Z, Wittenborn JS, et al. Prevalence of glaucoma among US adults in 2022. Jama Ophthalmology. 2024;142;(11):1046-1053. doi:10.1001/jamaophthalmol.2024.3884

5. Ocular hypertension. Cleveland Clinic. Updated August 19, 2022. Accessed August 27, 2026. https://my.clevelandclinic.org/health/diseases/24621-ocular-hypertension