When was OZURDEX approved? A timeline of FDA clearances for key ophthalmological conditions

October 11, 2025 •

4 min read

OZURDEX received its initial FDA approval on June 17, 2009, specifically for treating macular edema following retinal vein occlusion. This marked the first step in a phased approval process for the sustained-release dexamethasone implant, providing a clear answer to the question of when was OZURDEX approved for its different indications.

Quick Summary

The FDA first approved the dexamethasone intravitreal implant, OZURDEX, in June 2009 for retinal vein occlusion-related macular edema. It received subsequent approvals for non-infectious uveitis in September 2010 and diabetic macular edema with expansions in 2014, detailing its phased regulatory history.

Key Points

Initial Approval (2009): OZURDEX first received FDA approval on June 17, 2009, specifically for treating macular edema following retinal vein occlusion.
Uveitis Approval (2010): The FDA expanded OZURDEX's use on September 24, 2010, to include non-infectious uveitis affecting the posterior segment of the eye.
DME Approvals (2014): Multiple approvals occurred in 2014 for diabetic macular edema, initially for specific patient groups in June and later expanding to the general DME population in September.
Mechanism of Action: OZURDEX is a biodegradable implant that releases the corticosteroid dexamethasone over an extended period to reduce inflammation in the retina.
Common Side Effects: The most frequent adverse events include temporary increases in intraocular pressure (IOP) and the formation of cataracts with repeated use.
Method of Administration: The medication is delivered via a minimally invasive intravitreal injection procedure performed in a doctor's office.
Comparison to Anti-VEGF: Compared to anti-VEGF therapies, OZURDEX offers sustained action but has a different risk profile, particularly concerning IOP and cataract development.

The Staggered Approval Process for OZURDEX

OZURDEX (dexamethasone intravitreal implant) is a biodegradable, sustained-release corticosteroid implant used to treat several serious eye conditions. The approval of OZURDEX by the U.S. Food and Drug Administration (FDA) did not happen all at once but was instead granted in stages, corresponding to specific clinical indications. This phased approach allowed the FDA to evaluate the drug's safety and efficacy for different patient populations over time.

Initial Approval for Macular Edema (June 2009)

The journey for OZURDEX began in 2009. The FDA granted its first approval on June 17, 2009, for the treatment of macular edema associated with retinal vein occlusion (RVO). This approval was based on clinical studies demonstrating the implant's effectiveness in reducing macular swelling and improving visual acuity in patients with either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). RVO is a condition where a blood clot in the retinal veins causes fluid to leak into the macula, the central part of the retina responsible for sharp, central vision. The sustained-release action of OZURDEX provided a new treatment option for managing this inflammatory response.

Expanding Indications: Non-Infectious Uveitis (September 2010)

Following its initial success, OZURDEX received its second major FDA approval on September 24, 2010, for a new indication: non-infectious uveitis affecting the posterior segment of the eye. This chronic inflammatory condition can cause significant vision loss. Clinical trials showed that a single injection of OZURDEX was significantly more effective than a sham injection in reducing vitreous haze, a marker for inflammation, and improving visual acuity in patients with posterior uveitis. This expansion solidified OZURDEX's role as a versatile anti-inflammatory agent for a broader range of ophthalmic conditions.

Multiple Approvals for Diabetic Macular Edema (2014)

In 2014, OZURDEX received two key approvals for diabetic macular edema (DME), a common complication of diabetes and a leading cause of vision loss. The first was in June 2014 for DME in specific patient populations, including those with an artificial lens implant (pseudophakic) or those scheduled for cataract surgery (phakic). Later that year, in September 2014, the FDA approved a revised, broader indication for OZURDEX to treat DME in the general patient population. This broader approval was supported by long-term clinical data from the MEAD study, which demonstrated its efficacy in treating DME without the need for monthly injections.

How OZURDEX Works

OZURDEX's mechanism of action relies on the controlled, slow release of dexamethasone, a powerful corticosteroid. The implant, a tiny rod-shaped device, is injected into the vitreous humor, the jelly-like substance filling the back of the eye. The implant then gradually dissolves over several months, releasing the anti-inflammatory medication directly to the retina. Dexamethasone suppresses inflammation by inhibiting various inflammatory cytokines, reducing edema, fibrin deposition, and capillary leakage, ultimately helping to improve visual acuity. This sustained delivery system offers a significant advantage by reducing the frequency of injections compared to other treatments.

Administering the Intravitreal Implant

The administration of the OZURDEX implant is a minor, in-office procedure performed by a qualified ophthalmologist. The process includes:

Patient preparation: The eye is cleaned and numbed with a local anesthetic to ensure comfort.
Injection: The implant is delivered using a single-use applicator, which is the size of a pen. The applicator releases the implant into the vitreous cavity.
Confirmation: The doctor confirms proper placement of the implant using an indirect ophthalmoscope.
Post-procedure care: The patient is monitored for potential complications such as increased intraocular pressure (IOP) or infection and is advised to follow all post-procedure instructions.

Comparison of Treatment Options

For conditions like macular edema, OZURDEX is often considered alongside other treatments, most notably anti-VEGF (anti-vascular endothelial growth factor) therapy. While both are effective, they differ in mechanism and side effect profiles. The choice of treatment depends on a patient's specific condition and history.


Feature	OZURDEX (Dexamethasone Implant)	Anti-VEGF Therapy (e.g., Eylea, Lucentis)
Mechanism of Action	Anti-inflammatory corticosteroid that reduces edema and inflammation.	Inhibits the growth factor (VEGF) that promotes blood vessel leakage.
Duration of Effect	Sustained release over several months, reducing injection frequency.	Typically requires more frequent injections (e.g., monthly).
Primary Adverse Events	Increased intraocular pressure (IOP) and cataracts, especially with repeat injections.	Lower risk of IOP elevation and cataracts compared to Ozurdex.
Best for	Macular edema with significant inflammation, non-infectious uveitis.	First-line treatment for many forms of macular edema, including DME and RVO.
Considerations	Recommended for patients with suboptimal response to anti-VEGF therapy or with significant inflammation.	Standard of care for many macular edema conditions; higher injection frequency may be a factor for some patients.

Side Effects and Patient Considerations

As with any medication, OZURDEX carries potential side effects, which patients should discuss with their doctor. The most common adverse effects observed in clinical trials were:

Increased intraocular pressure (IOP), often peaking around two months post-injection. This can usually be managed with medicated eye drops but requires careful monitoring.
Cataract formation, especially in patients who still have their natural lens and receive repeated treatments. This may require subsequent cataract surgery.
Conjunctival hemorrhage, a common side effect of the injection itself.

Patients should be aware of important contraindications, including a history of certain eye infections or pre-existing conditions like advanced glaucoma or a ruptured posterior lens capsule.

Conclusion

The FDA's approval of OZURDEX occurred in several distinct phases, reflecting its expanded use across different ophthalmological conditions. Starting with retinal vein occlusion in 2009, followed by non-infectious uveitis in 2010, and finally encompassing diabetic macular edema in 2014, the approval timeline showcases the systematic process of bringing this sustained-release treatment to market for patients with inflammatory eye diseases. For millions affected by these conditions, knowing when was OZURDEX approved represents a key milestone in the development of targeted and effective therapeutic options.

For more information on the original approval, see the FDA's drug approval package: Drug Approval Package: OZURDEX.

Frequently Asked Questions

OZURDEX is a dexamethasone intravitreal implant approved by the FDA for the treatment of macular edema following retinal vein occlusion (RVO), non-infectious uveitis affecting the posterior segment, and diabetic macular edema (DME).

The implant releases a corticosteroid called dexamethasone directly into the vitreous cavity of the eye. Dexamethasone acts as a potent anti-inflammatory agent, reducing swelling and capillary leakage in the retina over a sustained period as the implant biodegrades.

Yes, the FDA approved OZURDEX for different indications at different times. It was first approved for RVO in 2009, for posterior uveitis in 2010, and for diabetic macular edema in 2014.

Common side effects include elevated intraocular pressure (IOP) and the development of cataracts. These can often be managed with additional treatment, but monitoring is necessary.

The procedure is performed after administering a local anesthetic to numb the eye, minimizing discomfort. While some pressure may be felt during the injection, it is typically not painful.

Due to its sustained-release mechanism, the implant slowly dissolves over several months. Re-treatment is typically considered after approximately 6 months, though the exact timing depends on the patient's condition and the doctor's assessment.

Yes, clinical guidelines suggest that OZURDEX can be an option for patients with diabetic macular edema who have had a suboptimal response to anti-VEGF treatment.