Omidenepag Isopropyl Ophthalmic Solution - Indications, Pharmacology, Warnings, and Precautions

Overview:

Omidenepag Isopropyl is marketed as an ophthalmic solution with a concentration of 0.002 percent to be applied to the eyes to tackle the manifestations of glaucoma. In 2022, the Food and Drug Administration (FDA) endorsed and authorized the usage of 0.002 percent of Omidenepag Isopropyl solution for patients suffering from an ophthalmic condition called glaucoma, in which the patients experience boosted pressure within the eyes. It was first developed by a pharmaceutical company in Japan. It tackles the condition by depreciating the pressure inside the eyes, relieving the discomfort and manifestations associated with it.

Drug Group:

Omidenepag Isopropyl ophthalmic solution falls under the drug group of selective prostaglandin E2 receptor agonists, facilitating the outflow of fluid inside the eyes. These drug groups are considered to be the hallmark medicine for glaucoma.

Available Doses and Dosage Forms:

• Dosage Forms: It is approved and distributed in the form of eye drops, which can be infused into the eyes manually by the patient or with the help of another person.

• Available Doses: Omidenepag Isopropyl ophthalmic solution is available in 0.002 percent concentration, where each milliliter of the eye drop contributes to 0.02 milligrams (mg) of the Omidenepag isopropyl drug molecules upon administration.

For Patients:

What Is Glaucoma?

Glaucoma encompasses a wide range of eye conditions that arise from enhanced eye pressure. The human eye is a delicate and sensitive organ that aids in vision. There is a normal range within which the pressure inside the eyes (eyeballs) should fall so that the eye can function healthily and efficiently. The pressure felt within the eye is technically coined intraocular pressure. Whenever this intraocular pressure exhibits an appreciable rise, it can give rise to conditions like glaucoma over time.

Enhanced intraocular pressure impairs and wrecks the optic nerves that are integral to healthy vision. Harmed optic nerve reflects vision errors, which later progress into compromised vision. The affected patient often complains of pressure or soreness in the eye, accompanied by a headache. Visual defects in the form of a collapsed field of vision and dark spots in the visual field are other manifestations of glaucoma. In addition, the light sources often appear with a rainbow-like aura encircling the source point. Progressively, it eats up the person's vision and can lead to blindness without prompt therapy to tackle its advancements.

How Does Omidenepag Isopropyl Ophthalmic Solution Work?

Omidenepag Isopropyl ophthalmic solution works for glaucoma by gearing down the projected intraocular pressure. The fluid collection within the eye can add to the elevation and appreciation of the intraocular pressure. Omidenepag facilitates the outward movement of the gathered eye fluid, automatically bringing down the pressure build-up in the eyes. Persistent pressure build-up is believed to be the triggering factor behind glaucoma progression. Omidenepag evokes all the drainage pathways to clear up the fluid gathering within the eyes.

What Is the Dosage of Omidenepag Isopropyl Ophthalmic Solution?

A 0.002 percent is the marketed concentration of Omidenepag Isopropyl ophthalmic solution. A single drop of the solution is the preferred daily dosage regimen for glaucoma patients. It is usually advised to infuse the drop in the evening, following a regular time for all day, to ensure consistent medicine concentration during the treatment therapy.

How Effective Is Omidenepag Isopropyl Ophthalmic Solution?

The efficacy of Omidenepag Isopropyl ophthalmic solution has been demonstrated and established by comparative clinical trials with other potent antiglaucoma eye drops like Latanoprost. The 0.002 percent is reported to be the efficacious and ideal concentration of Omidenepag Isopropyl for tackling glaucoma. A single dose of one drop of Omidenepag eye drop is sufficient to precipitate a preferable markdown in the intraocular pressure. The patient response to Omidenepag was analogous with other prostaglandin analog medicines for glaucoma. It was also concluded that Omidenepag could alleviate intraocular pressure appreciably, even in patients where other prostaglandin analogs failed to bring in desirable effects.

What Are the Things to Inform the Doctor Before Taking the Drug?

Before commencing the therapy using Omidenepag Isopropyl ophthalmic solution, there are some things to inform the concerned doctors.

• Any allergic encounter or hyperreactivity upon exposure to Omidenepag or other medicines belonging to the same class should be informed to the doctor before initiating the treatment. If such allergies exist, there are chances for potentially dangerous allergic events using Omidenepag Isopropyl eye drops. Allergy to any of the components in the eye drop should be ruled out. In case of doubtful reactions, allergy tests should be done under medical supervision to clear the uncertainty.

• Accurate medical history of the patient should be provided to the doctor, including previous cataract surgery (operation done for clearing the lens fogginess) or any other eye disorder, even if completely cured. Traumatic impact on the eye should also be informed to the doctor without fail.

• Along with medical history, the doctors should be provided with a detailed drug history, including all the medicines. Simultaneous drug usage poses challenges of drug-to-drug association and has a consequential impact on the potency and safety of both medicines.

• Doctors should be made aware of the pregnancy and lactating status of the patient before starting their therapy using Omidenepag Isopropyl ophthalmic solution. Expectant mothers and breastfeeding women should take the medicine only after consulting with a doctor.

• Omidenepag Isopropyl ophthalmic solution may enhance the eyes' light sensitivity, making it difficult for the person to drive, especially at night. Those constantly involved in driving should inform the doctor beforehand so that the doctor can change the medication choice.

How Is Omidenepag Isopropyl Ophthalmic Solution Administered?

Omidenepag Isopropyl ophthalmic solution, being an eye drop, should be infused into the eyes topically. Shaking or agitating the eye drop bottle before using it is always advised. It helps in homogenizing the solution contents, which may impact its effectiveness. In the case of patients with multiple eye drops, care should be employed not to infuse all the drops in a single stretch, but rather a break of not less than five minutes should be given between each medicine infusion. This provides enough time for the medicine to get absorbed into the eyes and prevent direct interaction with another medicine. For patients wearing contact lenses, it is advised to instill the drops with the lens off, which can be replaced after 15 to 20 minutes.

What Are the Side Effects of Omidenepag Isopropyl Ophthalmic Solution?

Some of the widely reported side effects associated with Omidenepag include:

• Visual Disturbances: The vision becomes unclear and hazy during the therapy. It is often accompanied by exaggerated light sensitivity and compromised color vision (challenges in distinguishing colors).

• Eye Discomfort: Eye irritation and occasional redness are also reported with Omidenepag therapy. These are quite transient and do not persist throughout the treatment regime. Patients may experience immediate soreness and dryness in the eye, especially after applying eye drops.

• Altered Eye Color: Some reports suggest an alteration in eye color following the topical therapy using Omidenepag. Though it is not encountered frequently, the changes are primarily irreversible and remain even after the cessation of the drug.

Dietary Considerations:

Omidenepag is a topical ophthalmic solution. Therefore, no specific dietary considerations need to be followed while on the therapy. If the patient is on some other medication that demands specific dietary considerations, those patients can stick to that dietary modification even after introducing Omidenepag.

Missed Dose:

If the patient forgets to instill the drops at the specified time, it is advised to administer them when the patient becomes aware of the missed one. However, if the patient recalls the missed dose the next day, close to the subsequent dose administration time, the patient can ignore the missed one. No dose duplication is required to counterbalance the missed one, which can lead to overdose issues and other problems. Even if one day's dose is missed, the patient can continue with the single-drop regime the next day. No dose alteration is acceptable without medical advice.

Overdose:

Infusing more than the specified dose of Omidenepag can bring in overdose issues. There are no reliable reports concerning the overdosing of Omidenepag ophthalmic solution.

Storage:

Omidenepag Isopropyl ophthalmic solution is marketed in a polyethylene bottle with a dropper tip, and it should be stored within the same until the time of administration. Sealed eye drop bottles should be kept at a temperature range of two to eight degrees Celsius (36 to 46 degrees Fahrenheit). Hence it should be refrigerated. Once the seal is opened, it can be kept at room temperature (30 degrees Celsius) for one month.

For Doctors:

Indication:

• Open-angle glaucoma.

• Ocular hypertension.

Dose:

The daily dose for treating open-angle glaucoma is just one drop of Omidenepag ophthalmic solution with a 0.002 percent concentration. The evening is the most preferred time for the administration. However, it can be flexible.

Dosing Considerations:

There is no specific dosing consideration for Omidenepag ophthalmic eye solution. One drop is the routine dosage advised, and the treating physician can make dose adjustments after analyzing the patient's health status and underlying medical conditions.

What Are the Pharmacological Aspects of Omidenepag Isopropyl Ophthalmic Solution?

• Mechanism: Being an EP2 receptor agonist, Omidenepag Isopropyl ophthalmic solution works to bring down intraocular pressure. After topical administration of the ophthalmic solution, the Omidenepag Isopropyl molecule, which is in the prodrug form, breaks down into its pharmacologically active form - Omidenepag. This hydrolysis reaction happens once the ophthalmic solution penetrates the corneal layer of the eye. This metabolite enhances the outrush of the aqueous humor by facilitating the actions of trabecular meshwork and the ciliary body concerned with the drainage of aqueous humor. This outflow directly impacts intraocular pressure (IOP), and the enhanced outflow then gears down the IOP.

• Pharmacokinetics: Omidenepag absorption occurs through the cornea, where the inactive drug molecule transforms into its active form. The enzyme carboxylesterase-1 catalyzes this conversion. The utmost plasma concentration of the Omidenepag is reported at around 10 to 15 minutes following the drug instillation. Liver enzymes carry out the breakdown of the active metabolite. The removal of the drug happens via fecal and urinary routes, where almost 83 percent of elimination is reported to be through the feces and the rest through urine.

• Pharmacodynamics: Once the body identifies the drug, which happens in the corneal layer, an enzyme-mediated hydrolysis reaction will be triggered, which precipitates the formation of active Omidenepag.

Toxicity:

There is no clinical evidence suggesting the role of Omidenepag Isopropyl ophthalmic solution in cancer development. However, certain short-term animal trials using Omidenepag as subcutaneous injections at very high doses have proven the carcinogenic potential. Nephroblastoma, mammary adenocarcinoma, spermatic cord tumors, and pituitary adenomas were identified in the rodents treated with subcutaneous doses of Omidenepag. In-vivo tests of Omidenepag in rats failed to elicit any mutagenic properties, while in-vitro studies exposed certain clastogenic and mutagenic effects. Infertility is also not projected with Omidenepag when administered to rats for experimental purposes.

Clinical Studies:

Clinical studies were conducted for Omidenepag in patients with ocular hypertension or open-angle glaucoma. Studies compared the range of intraocular pressure reduction upon Omidenepag's administration with other standard drugs like Latanoprost and Timolol. It was concluded that the results obtained with Omidenepag were on par with the standard control drugs in bringing down the elevated IOP.

What Are the Contraindications of Omidenepag Isopropyl Ophthalmic Solution?

There are no specific contraindications reported for Omidenepag Isopropyl ophthalmic solution. However, allergy to Omidenepag or its related medicines is a potential contraindication for Omidenepag.

Warnings and Precautions:

• Macular Edema: Omidenepag administration potentially raises the risk of developing macular edema. Special caution should be emphasized while advising Omidenepag to patients with pseudophakia or aphakia.

• Pigmentation: Omidenepag is known to precipitate pigmentation in ocular and periocular structures. The iris elicits color change, attributed to a remarkable rise in the melanocyte's melanin content. In addition to the iris, eyelashes and the skin surrounding the eyes also develop pigmentation. Once the Omidenepag is withdrawn, the pigmentation gradually resolves over time. However, the iris color change is often fixed and permanent, with less scope for color recovery.

• Changes in the Eyelash Structure: Long-term infusion of Omidenepag induces structural changes in the eyelashes, like enhanced eyelash number, thickness, and length. These changes are transient, and upon withdrawal of Omidenepag therapy, these changes will be resolved.

• Possibility for Medicine Contamination: Frequent touching of the dropper tip to eyes or fingers may infect and spoil the ophthalmic solution. Hence, it should be employed not to make any contact with the dropper tip to keep it sterile and germ-free. In addition, the tip's contact with the eye may inflict traumatic eye injuries.

• Ocular Inflammation: Persistent use of Omidenepag may precipitate inflammatory changes in the eyes, and the patients should be informed about this prior. If the patient already has active eye inflammation, Omidenpag worsens the condition, so it should be cautiously advised.

• Use With Contact Lenses: When used in contact lens wearers, it is mandatory to take the lens off before Omidenepag infusion. The medicine should be given 15 minutes before wearing the lens for the drug to get absorbed into the eye; then, only the lens can be reinserted.

What Are the Drug Interactions of Omidenepag Isopropyl Ophthalmic Solution?

There are no specific drug-to-drug interactions reported with Omidenepag Isopropyl ophthalmic solution. However, if the patient is under multiple eye drop therapy, back-to-back instillation of the drops is strictly warned. A minimum of five minutes should be given between each eye drop to check unwanted interactions and their adverse reactions in the eyes.

Specific Considerations:

• Omidenepag During Pregnancy: The lack of clinical study reports, makes it difficult to arrive at a specific conclusion regarding the use of Omidenepag in pregnant ladies. Subcutaneous administration of Omidenepag in animals at a significantly higher dosage projected skeletal anomalies. Animal studies are not conclusive evidence for human usage; hence, doctors analyze the case by considering the maternal need for the medicine and the projected risk to the fetus.

• Omidenepag During Breastfeeding: No reliable data is available concerning the transmission of the drug molecules from the maternal body to the child through breast milk. Hence, the doctors consider the case and make the decision accordingly.

• Omidenepag in the Pediatric Population: Omidenepag is not scientifically tested for pediatric usage and is not widely advised.