BRIEF SUMMARY

OOMIDENEPAG-(Sep 2022)

Indn-  To reduce elevated intraocular pressure in   patients  with open Glaucoma or                  Ocular   hypertension                                                                                                                             

Comp-  Ophthalmic solution containing 0.002% (0.02 mg/mL) of omidenepag isopropyl.

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

ADR- 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%). 

CI- None 

WARNINGS-

Pigmentation.  Eyelash changes . Ocular Inflammation.  Macular Edema.

Pat Inform-

Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent,.about the possibility of eyelid skin darkening, which is usually reversible after discontinuation of Omlonti.

Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Omlonti. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes .

================================================================

U.S.  APPROVED DRUGS SURING 2022                                        

Serial No 24

Name-        OMLONTI                

Active Ingredient -   Oomidenepag

Pharmacological Classification- To reduce elevated intraocular pressure in                                                                       patients  with open Glaucoma or Ocular                                                                        hypertension                                                                                                                             

Date of Approval-         9/22/2022          

 HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use                       OMLONTI® safely and effectively.                                                                                See full prescribing information for OMLONTI®. OMLONTI® (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use

Initial U.S. Approval: 2022

INDICATIONS 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.

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%). 

CONTRAINDICATIONS-

 None 

WARNINGS AND PRECAUTIONS-

Pigmentation.                                                                                                                        Eyelash changes                                                                                                             Ocular Inflammation                                                                                                     Macular Edema.

DOSAGE AND ADMINISTRATION-

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

DOSAGE FORMS AND STRENGTHS-

 Ophthalmic solution containing 0.002% (0.02 mg/mL) of omidenepag isopropyl.

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Potential for Pigmentation-                                                                                           Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which is usually reversible after discontinuation of Omlonti.

Potential for Eyelash Changes-                                                                               Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Omlonti. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

Eyelash changes -                                                                                                         are usually reversible upon discontinuation of treatment.

Handling the Container-                                                                                           Advise patients to avoid touching the tip of the bottle to the eye or any surface, as this may contaminate the solution. Advise patients to not touch the tip to their eye to avoid the potential for injury to the eye.

The product should be refrigerated before opening, and once it is opened, it can be stored at room temperature for up to 31 days.  

When to Seek Physician- Advice Advise patients that if they develop a new ocular condition (e.g., trauma, infection, or inflammation), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of Omlonti.

Use with Contact Lenses- Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes after administration.

Use with Other Ophthalmic Drugs -Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart 

 Manufactured for: Santen Inc. Manufactured by: Woodstock Sterile Solutions, Inc. Distributed by: Santen Inc. 6401 Hollis Street, Suite 125 Emeryville, CA 94608 United States

 CLINICAL PHARMACOLOGY                                                                                   

1. Mechanism of Action-                                                                                 Omidenepag is a relatively selective EP2 receptor agonist which decreases intraocular pressure (IOP). The exact mechanism of action is unknown at this time

2. Pharmacokinetics -                                                                                                Absorption- Omlonti is absorbed through the cornea where prodrug omidenepag isopropyl is hydrolyzed to become biologically active metabolite, omidenepag.

After once daily ocular administration of one drop of omidenepag isopropyl 0.0025% eye drops to both eyes in humans for 7 days, plasma concentrations of omidenepag reached Cmax at 10- 15 minutes. Systemic exposure was similar between days 1 and 7, indicating no systemic accumulation.

Elimination-                                                                                                              Metabolism -After topical ocular administration, omidenepag isopropyl is rapidly metabolized in the eye to omidenepag (active moiety) by carboxylesterase-1.

Excretion-                                                                                                                         In rats, 0.03% 14C-Omlonti was instilled in both eyes as a single dose (5 mcL/eye, 3 mcg/animal). By 168 hours after ocular instillation, 89% of the administered radioactive dose had been excreted. Specifically, 83% and 4% of the administered radioactive dose were excreted in the feces and urine, respectively, and radioactivity in expired air was below the lower limit of quantitation.

 USE IN SPECIFIC POPULATIONS

1. Pregnancy Risk Summary-                                                                                   There are no available data on the use of Omlonti in pregnant women.

In animal reproduction studies, subcutaneous administration of omidenepag isopropyl to pregnant rabbits throughout the period of organogenesis produced fetal skeletal anomalies at a dose of 24 times the clinical dose, based on estimated plasma Cmax.

2. Lactation Risk Summary -                                                                                    There are no data on the presence of Omlonti in human milk, the effects on the breastfed infant, or the effects on milk production.

However, systemic exposure to omidenepag following topical ocular administration is low, and it is not known whether measurable levels of omidenepag would be present in maternal milk following topical ocular administration.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Omlonti and any unknown potential adverse effects on the breast-fed child from Omlonti.

3. Females and Males of Reproductive Potential Infertility-                                  There are no data on the effects of Omlonti on human fertility.                                       

4. Pediatric Use-                                                                                                           The safety and effectiveness of Omlonti have not been established in pediatric patients.

5. Geriatric Use -                                                                                                            No overall differences in safety or effectiveness have been observed between elderly and other adult patients.