MedPath logo

EYBELIS OPHTHALMIC SOLUTION 0.002%

Prescription Only
Drug type: Therapeutic
ATC code: S01EX06
Dosage form: SOLUTION, STERILE
Route of administration: OPHTHALMIC
Active ingredient: Omidenepag isopropyl; OMIDENEPAG ISOPROPYL

Therapeutic indications

Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in ‘Description’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with aphakic eyes or intraocular lens (IOL) inserted eyes (see ‘Undesirable effects’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant use with tafluprost (see ‘Interactions’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology and method of administration

Posology

The recommended dose is one drop in the affected eye(s) once daily in the evening.

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

Paediatric population

The safety and efficacy of omidenepag isopropyl in children and adolescents have not yet been established. No data are available.

Method of administration

For ocular use.

Be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.

If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

Benzalkonium chloride may change the colour of the contact lenses. Contact lens wearers should remove the contact lenses before using this product and put them back after 5–10 minutes.

Registrant
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Approval Date
2021-04-07
Approval Number
SIN16150P
Manufacturer
Santen Pharmaceutical Co., Ltd. Shiga Plant
Licence Holder
SANTEN PHARMACEUTICAL ASIA PTE. LTD.