Advancing Ocular Health
Advancing Ocular Health
Episode 1

Alleviate with ZERVIATE™ – First New Molecule for Allergic Conjunctivitis in Over 10 Years!

In the first installment, Ranjan P. Malhotra, MD, FACS, and Eric T. Brooker, OD, FAAO, discuss safety and phase 3 data of ZERVIATE™, the first topical ocular formulation of cetirizine. ZERVIATE™ formulated with Hydrella is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Zerviate™ Important Safety Information

7/16/2020 | 22:48

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INDICATIONS AND USAGE

ZERVIATE™ (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.

DOSAGE AND ADMINISTRATION
Instill one drop of ZERVIATE in each affected eye twice daily (approximately 8 hours apart).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Contamination of Tip and Solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single-use container to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye.

Contact Lens Wear: Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE.

ADVERSE REACTIONS

The most commonly reported adverse reactions occurred in approximately 1%–7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced.

Please see the Full Prescribing Information.


INDICATIONS AND USAGE

For steroid responsive inflammatory ocular conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe and chronic anterior uveitis, corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies for which a corticosteroid is indicated and where the risk of superficial bacterial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Most viral disease of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Hypersensitivity to any components of the medication.

WARNINGS & PRECAUTIONS:

  • IOP increase – Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. IOP should be monitored.
  • Aminoglycoside sensitivity – Sensitivity to topically applied aminoglycosides may occur.
  • Cataracts – Posterior subcapsular cataract formation may occur.
  • Delayed healing – May delay healing and increase the incidence of bleb formation. Perforations of the cornea or sclera have occurred. Slit lamp biomicroscopy, and fluorescein staining should be conducted.
  • Bacterial infections – May suppress host response and increase secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Viral infections – Use with history of herpes simplex requires great caution. The course and severity of many viral infections of the eye (including herpes simplex) may be exacerbated.
  • Fungal infections – Fungal infections of the cornea may occur and should be considered in any persistent corneal ulceration.
  • Use with systemic aminoglycosides – Total serum concentration of tobramycin should be monitored.

ADVERSE REACTIONS:

The most frequent adverse reactions (<4%) to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelid pruritus, eyelid edema, and conjunctival hyperemia.

The reactions due to the steroid component are increased intraocular pressure with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.

The development of secondary infection has occurred. Fungal infections of the cornea may occur. Secondary bacterial ocular infection following suppression of host responses also occurs.

Non-ocular adverse events (0.5% to 1%) included headache and increased blood pressure.

Please see the Full Prescribing Information.


INDICATIONS AND USAGE

FLAREX® (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

Topical Ophthalmic Use Only: Not for injection.
Intraocular Pressure Increase: Prolonged use may result in glaucoma, damage to the optic nerve, and defects in visual acuity and visual field. It is advisable that the intraocular pressure be checked frequently.

Cataracts: Use of corticosteroids may result in cataract formation.

Delayed Healing: Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids.

Viral Infections: Use in the treatment of herpes simplex infection requires great caution.

Bacterial Infections: Use of corticosteroids may suppress the host response and thus aid in the establishment of secondary ocular infections. Acute purulent infections of the eye may be masked or exacerbated by the presence of steroid medication.

Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

Contamination: Do not touch dropper tip to any surface as this may contaminate the suspension.

Contact Lens Wear: Contact lenses should be removed during instillation of FLAREX but may be reinserted after 15 minutes.

Temporarily Blurred Vision: Vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving a motor vehicle.

ADVERSE REACTIONS

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience: The following reaction has been identified during postmarketing use of FLAREX in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes dysgeusia.

Please see the Full Prescribing Information.

FLA-20-WB-52-00