Advertisement

Article | AAO 2026

An Update on Phase 3 Data from DENALI

Nora Lee Cothran, OD, FAAO, sat down with OM to discuss how NCX-470, bimatoprost grenod 0.1%, performed in the US subpopulation of patients who have glaucoma.

Optometric Management November 4, 2026

Clinical Scorecard: An Update on Phase 3 Data from DENALI

At a Glance

CategoryDetail
ConditionPrimary open-angle glaucoma or ocular hypertension
Key MechanismsNCX-470 (bimatoprost grenod 0.1%) is a nitric oxide-donating bimatoprost with dual mechanisms: the prostaglandin analog works within uveoscleral outflow, while the nitric oxide component works within the trabecular meshwork in conventional outflow.
Target PopulationThe DENALI US subpopulation included 549 patients with primary open-angle glaucoma or ocular hypertension who were washed out from prior glaucoma medications and randomized to NCX-470 or latanoprost.
Care SettingThe article reports phase 3 DENALI findings in a US subpopulation and includes an interview with an optometrist specializing in glaucoma and neurological eye disease.

Key Highlights

  • DENALI was a randomized, double-masked, active-controlled, parallel-group study conducted at 90 sites worldwide, including 65 US sites.
  • In the US subpopulation, NCX-470 met the primary endpoint of noninferiority to latanoprost 0.005% at all measured timepoints.
  • IOP was lower with NCX-470 at all measured timepoints and statistically significantly lower at 3 of 6 timepoints; average IOP reduction in the investigative arm was reported as 8.1 to 10.1 mmHg.
  • The interview reports that NCX-470 was well tolerated, with no serious treatment-related adverse events during the study.
  • IOP was measured at weeks 2 and 6 and month 3, at 8:00 AM and 4:00 PM.

Guideline-Based Recommendations

Diagnosis

    Management

    • The interviewee says AAO treatment guidance for starting medication in a newly diagnosed patient with glaucoma is to lower IOP by 20% to 30%.
    • The presenter challenges colleagues to consider switching to a dual-mechanism treatment; the supplied excerpt does not specify a patient subgroup.

    Monitoring & Follow-up

    • DENALI measured IOP at week 2, week 6, and month 3, at 8:00 AM and 4:00 PM.

    Risks

    • The interview states that patients may be unaware of how severe glaucoma can become if the disease goes unmanaged or is not actively managed.

    Patient & Prescribing Data

    The US DENALI subpopulation included 549 participants with primary open-angle glaucoma or ocular hypertension who were washed out from prior glaucoma medications and randomized to NCX-470 or latanoprost.

    NCX-470 was compared with latanoprost 0.005%. The interview reports average IOP reduction of 8.1 to 10.1 mmHg in the NCX-470 arm and no serious treatment-related adverse events; it does not provide dosing details.

    Clinical Best Practices

    • The presenter emphasizes active management and earlier treatment of glaucoma.
    • The presenter describes optometry as the first line of defense and says clinicians can choose what is best for each patient.
    • The presenter challenges colleagues to consider switching to a dual-mechanism treatment; the supplied excerpt does not specify a patient subgroup.

    Related Resources & Content