OZURDEX 700mcg Implant/Intravitreal

What is OZURDEX 700mcg

OZURDEX 700mcg is a sustained-release intravitreal implant containing dexamethasone, a potent corticosteroid. It is specifically designed for administration directly into the vitreous humor of the eye to treat various inflammatory and edema-related eye conditions.

• Active Ingredient: Dexamethasone 700 micrograms delivered via a biodegradable implant.
• Formulation: A solid implant preloaded into a sterile applicator for intravitreal injection.
• Indications: OZURDEX is primarily used to manage macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), non-infectious uveitis affecting the posterior segment of the eye, and other inflammatory ocular conditions.
• Therapeutic Benefits: The implant releases dexamethasone gradually over several months, reducing inflammation, vascular permeability, and swelling in the retina to improve or stabilize vision.
• Usage Setting: Administered by ophthalmologists in clinical settings under sterile conditions to ensure safety and efficacy.

By delivering corticosteroids directly inside the eye, OZURDEX provides targeted therapy that minimizes systemic exposure and maximizes local effect.

How to use OZURDEX 700mcg

The administration of OZURDEX 700mcg requires precision and expertise to ensure safety and effectiveness:

• Preparation: The implant comes preloaded in a single-use applicator. The patient’s eye should be prepared with appropriate antiseptic measures, typically using povidone-iodine solution to reduce infection risk.
• Anesthesia: Local anesthesia is applied to the eye surface or via subconjunctival injection to minimize discomfort during implantation.
• Injection Procedure: The implant is injected directly into the vitreous cavity through the pars plana region using the applicator. The procedure is quick, usually taking only a few minutes.
• Post-Procedure Care: Patients may be prescribed topical antibiotics or anti-inflammatory drops to prevent infection and control inflammation.
• Monitoring: Follow-up appointments are essential to monitor intraocular pressure (IOP), retinal health, and response to treatment.
• Repeat Dosing: The implant may be repeated every 3 to 6 months based on clinical response and physician assessment.
• Contraindications: Do not administer if active ocular infections or other contraindications are present.

Administration must be performed by a trained ophthalmologist using sterile technique to minimize complications.

Mode of Action OZURDEX 700mcg

OZURDEX works through the potent anti-inflammatory effects of dexamethasone delivered directly into the vitreous body:

• Anti-Inflammatory Action: Dexamethasone binds to glucocorticoid receptors within cells, modulating gene expression to inhibit the production of inflammatory mediators such as prostaglandins, cytokines, and leukotrienes.
• Reduction of Vascular Permeability: By stabilizing endothelial tight junctions, it reduces leakage from blood vessels that contribute to macular edema.
• Inhibition of Immune Cells: Suppresses infiltration and activation of inflammatory cells within the ocular tissues.
• Biodegradable Implant: The implant slowly releases dexamethasone over 3 to 6 months, providing sustained therapeutic levels while biodegrading into inert components that are naturally eliminated.
• Local Delivery: Targeted intraocular administration maximizes drug concentration at the site of pathology while minimizing systemic side effects.

This mechanism leads to decreased swelling, improved retinal function, and stabilization or improvement of vision in affected patients.

OZURDEX 700mcg Interactions OZURDEX 700mcg

Due to its localized administration, systemic drug interactions are limited but several ocular and systemic considerations apply:

• Other Corticosteroids: Concurrent use with systemic or topical corticosteroids may increase the risk of steroid-related adverse effects such as elevated intraocular pressure (IOP) or cataract formation.
• Intraocular Pressure Elevating Agents: Drugs that raise IOP should be used cautiously, as dexamethasone can independently increase IOP in susceptible individuals.
• Antiglaucoma Medications: Patients on medications for glaucoma may need adjustments if IOP rises after OZURDEX implantation.
• Immunosuppressants: Systemic immunosuppressive therapy may potentiate the risk of infections; careful monitoring is required.
• Ocular Procedures: Prior or planned intraocular surgeries may influence timing and safety of OZURDEX implantation.
• Infection Risk: Concomitant use of agents that suppress immune response can elevate infection risk, especially endophthalmitis.

Inform your ophthalmologist about all current medications to ensure safe administration and monitoring.

Dosage of OZURDEX 700mcg

The dosage of OZURDEX is standardized and tailored to intravitreal implantation:

• Single Implant Dose: Each implant contains 700 micrograms of dexamethasone and is designed for single-use administration directly into the vitreous.
• Frequency: Typically, the implant may be repeated every 3 to 6 months based on clinical need, response, and physician evaluation.
• Adjustments: The dosing interval may be extended or shortened depending on the patient’s response, tolerance, and disease progression.
• Special Populations: Safety and efficacy in pediatric patients have not been well established; usage in such populations requires specialist assessment.
• Monitoring: IOP and ocular status should be assessed before and after implantation to guide repeat dosing decisions.

It is critical to follow the ophthalmologist’s instructions for timing and follow-up care to optimize therapeutic outcomes.

Possible side effects of OZURDEX 700mcg

While OZURDEX is generally well tolerated, it may cause ocular and systemic side effects, including:

• Common Side Effects:
• Increased intraocular pressure (IOP)
• Cataract formation or progression
• Eye pain or discomfort
• Conjunctival hemorrhage
• Floaters or blurred vision
• Less Common Side Effects:
• Intraocular inflammation
• Vitreous detachment
• Corneal edema
• Retinal detachment (rare)
• Serious but Rare Side Effects:
• Endophthalmitis (intraocular infection)
• Severe ocular hypertension resistant to treatment
• Hypersensitivity reactions

Patients should report any worsening vision, severe pain, or signs of infection immediately to their ophthalmologist.

OZURDEX 700mcg Contraindications OZURDEX 700mcg

OZURDEX should not be used in the following situations:

• Active Ocular Infections: Including bacterial, fungal, viral (e.g., herpes simplex), or parasitic infections of the eye.
• Hypersensitivity: Known allergy to dexamethasone, other corticosteroids, or any component of the implant.
• Glaucoma with Uncontrolled Intraocular Pressure: Patients with poorly controlled glaucoma are at increased risk of vision loss.
• Vitreous Hemorrhage or Retinal Detachment: Implantation may exacerbate or complicate these conditions.
• Pregnancy and Lactation: Use only if the potential benefits justify the potential risks to the fetus or infant.

Careful patient selection and ophthalmic examination are essential before administration.

Storage of OZURDEX 700mcg

Proper storage preserves the implant’s sterility and efficacy:

• Temperature: Store the implant at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F).
• Light Protection: Keep the implant in its original packaging away from direct sunlight to prevent degradation.
• Humidity: Store in a dry place to maintain integrity of the implant and applicator.
• Sterility: Do not remove the implant from its sterile packaging until immediately prior to administration.
• Expiry Date: Use the implant before the expiration date printed on the packaging.
• Handling: Only trained healthcare professionals should handle and administer the implant to maintain sterility and safety.

Following recommended storage conditions ensures the implant’s safety and performance for intravitreal use.