From Visiox Pharma
Approved
A relatively selective EP2 receptor agonist with a novel, first-in-class mechanism of action and prostaglandin-like efficacy.1,2
INDICATION AND USAGE
OMLONTI® (omidenepag isopropyl ophthalmic solution) 0.002% is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals.
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IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Pigmentation
Increased pigmentation of the iris, periorbital tissue, and eyelashes may occur. Iris pigmentation is likely to be permanent.
Eyelash Changes
Gradual change to eyelashes may include increased length, thickness, and the number of lashes or hairs. These changes are usually reversible upon discontinuation of treatment.
Ocular Inflammation
OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002% should be used with caution in patients with active ocular inflammation, including iritis/uveitis.
Macular Edema
Macular edema, including cystoid macular edema, has been reported in patients with pseudophakia. OMLONTI should be used with caution in aphakic patients, in pseudophakic patients, or in patients with known risk factors for macular edema.
Risk of Contamination and Potential Injury to the Eye
Advise patients to not touch the tip of the bottle to the eye or any surface to avoid contaminating the solution. Advise patients to not touch the tip to their eye to avoid the potential for eye injury.
ADVERSE REACTIONS
The most common adverse reactions with incidence ≥1% are conjunctival hyperemia (9%), photophobia (5%), vision blurred (4%), dry eye (3%), instillation site pain (3%), eye pain (2%), ocular hyperemia (2%), punctate keratitis (2%), headache (2%), eye irritation (1%), and visual impairment (1%).
Please click here to see the full Prescribing Information and Instructions for Use.
References:
1. OMLONTI [package insert]. Emeryville, CA: Santen Inc.
2. Aihara M. Prostanoid receptor agonists for glaucoma treatment. Jpn J Ophthalmol. 2021;65(5):581-590. doi:10.1007/s10384-021-00844-6
OMLONTI is a registered trademark of Santen, Inc.
SANTEN-US-230012 04/2023
Visiox Pharma
1349 W. Lane, Suite 1010
Columbus, OH 43221