The Food and Drug Administration (FDA) has approved omidenepag isopropyl (OMLONTI®) medicated eye drops for patient use.* The 0.002% ophthalmic solution is used for lowering internal eye pressure in people with primary open-angle glaucoma or ocular hypertension, generally defined as eye pressure over 21 mm Hg (millimeters of mercury).

About OMLONTI®

OMLONTI®, by Santen Inc. and UBE Corporation, is a prostaglandin drug designed to improve drainage of eye fluid (aqueous humor) through both the trabecular meshwork and uveoscleral outflow pathways. It is the only treatment to date that provides this dual action and is Santen’s first glaucoma product available in the U.S.

Equal to other eye drops in safety and effectiveness

The FDA based the drug’s approval on three randomized, controlled clinical trials involving people with either glaucoma or ocular hypertension and a baseline eye pressure of 24-26. 

All three studies were double-blind, meaning that neither the researchers nor patients knew who was receiving the treatment in question.

There were three comparative treatment groups within each of the three studies. All three studies showed reductions in eye pressure across all treatment groups. In all three trials:

• OMLONTI® decreased eye pressure by 5-7 mm Hg.
• Timolol also decreased eye pressure by 5-7 mm Hg.
• Latanoprost decreased eye pressure by 6-8 mm Hg.

The safety and tolerability of OMLONTI® was confirmed with 12 clinical trials involving 1,111 adults and six children. Adverse effects included:

• Macular edema
• Eye inflammation
• Possible increased eye pigmentation
• Eyelash changes

Another treatment option

Treatments that lower eye pressure help to preserve vision in people with glaucoma or ocular hypertension, but not everyone responds well to the same treatments. The approval of OMLONTI® offers patients and clinicians another alternative.

The drug’s U.S. approval comes on the heels of its approval in Japan and mainland Asia. Said UBE Corporation senior executive officer Yoichi Funayama, “We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen.”

*Pharmacy Times. (2022, September 26). FDA Approves Omidenepag Isopropyl for Elevated Intraocular Pressure in Primary Open-Angle Glaucoma, Ocular Hypertension. https://www.pharmacytimes.com/view/fda-approves-omidenepag-isopropyl-for-elevated-intraocular-pressure-in-primary-open-angle-glaucoma-ocular-hypertension

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