FDA Approves Drug for Open-Angle Glaucoma and Ocular Hypertension

In a recent press release, Santen announced that the FDA approved OMLONTI, the company’s newest ophthalmic medication. This ophthalmic solution is composed of 0.002% omidenepag isopropyl. This drug will lower intraocular pressure (IOP) for patients with ocular hypertension or open-angle glaucoma.

According to the press release, “glaucoma causes damage to the optic nerve resulting in visual field loss and remains a leading cause of irreversible blindness worldwide. Since the disease is generally progressive, early detection and treatment to control the progression are crucial, and lowering IOP is the most effective means of avoiding damage to the optic nerve.”

These chronic conditions are more likely to develop with age or unmanaged comorbidities such as systemic hypertension and diabetes.

The FDA approval follows the results of randomized clinical trials. Participants in these trials had a baseline IOP of 24–26 mm Hg. Patients received treatment with OMLONTI or control for approximately three months. Following treatment, patients receiving OMLONTI had an average IOP reduction between 5 and 7 mm Hg. These results persisted across all three iterations of the study.

Despite successful treatment results, OMLONTI, like any other drug, has some side effects. Across the 10 studies investigating the drop’s safety, the identified side effects include macular edema, pseudophakia, ocular inflammation, and changes in eye pigmentation.

“Treatments that focus on IOP reduction help to slow or prevent further loss of vision for those with glaucoma or ocular hypertension. However, not all patients respond to the same treatments, and some may not have successful outcomes,” said Jason Bacharach, MD, Medical and Research Director at North Bay Eye Associates, Inc, in the press release. “The approval of omidenepag isopropyl ophthalmic solution 0.002% provides doctors with another safe and effective option to use when treating patients with these sight-threatening conditions.”

While there are currently viable treatment options for ocular hypertension and open-angle glaucoma, this approval provides clinicians and patients with additional options to consider. Providers treating patients who have not succeeded with existing treatment options may consider implementing this new medication.