Is Durysta FDA Approved? An In-Depth Look at This Glaucoma Treatment

October 8, 2025 •

3 min read

On March 4, 2020, the U.S. Food and Drug Administration (FDA) approved the first-of-its-kind biodegradable implant, Durysta (bimatoprost implant), for the treatment of open-angle glaucoma and ocular hypertension. This approval introduced a new method for delivering medication directly into the eye, offering an alternative to daily eye drops for many patients.

Quick Summary

Durysta is an FDA-approved, biodegradable bimatoprost implant that lowers intraocular pressure in adults with open-angle glaucoma or ocular hypertension. It provides sustained medication release over several months, offering an alternative to daily drops, though it is approved for only one administration per eye due to safety concerns.

Key Points

FDA Approval Confirmed: Durysta was approved by the FDA on March 4, 2020, for treating open-angle glaucoma and ocular hypertension.
Sustained-Release Implant: It is a biodegradable implant containing bimatoprost that is injected into the eye and slowly releases medication over several months.
Improved Adherence: The implant eliminates the need for daily eye drops, significantly improving patient adherence to treatment.
Single-Dose Limitation: The FDA approved Durysta for only one administration per eye due to the risk of corneal cell damage with repeat dosing.
Contraindications: It is not suitable for patients with certain conditions, including active eye infections, corneal dystrophy, or prior corneal transplantation.
Consideration for Use: Patients should discuss the risks and benefits with their ophthalmologist, who can determine if the implant is an appropriate part of their long-term glaucoma management plan.

What is Durysta and how does it work?

Durysta is a small, dissolvable implant containing bimatoprost, a medication that reduces eye pressure. It is placed in the eye by an ophthalmologist and releases the medication over time as it dissolves. Bimatoprost works by increasing the drainage of fluid from the eye, which lowers intraocular pressure. This method offers a sustained and localized drug delivery.

The FDA approval of Durysta

Durysta received FDA approval on March 4, 2020, based on two Phase 3 clinical trials, the ARTEMIS studies. These trials showed that Durysta was effective in lowering intraocular pressure by approximately 30%. The approval provided a new option for patients with open-angle glaucoma or ocular hypertension, particularly those who have difficulty using daily eye drops.

Potential benefits of using Durysta

Durysta offers potential benefits compared to traditional eye drops:

Improved Adherence: A single implant replaces the need for daily eye drops for several months, which can improve how consistently patients receive treatment.
Consistent IOP Control: The continuous release of medication can lead to more stable eye pressure compared to the fluctuations that can occur with daily drops.
Reduced Side Effects: Delivering the medication directly to the eye can minimize the amount of drug that enters the bloodstream, potentially leading to fewer systemic side effects.
Minimally Invasive: The procedure to insert the implant is less invasive than surgical treatments for glaucoma.

Important risks and considerations

Durysta has specific risks and limitations:

Single-Dose Limit: The FDA approved Durysta for only one administration per eye due to an increased risk of corneal cell loss with repeat treatments.
Corneal Adverse Reactions: There is a risk of corneal cell loss, and the implant should not be used in patients with pre-existing corneal issues like Fuchs’ Dystrophy.
Risk of Inflammation: Like other similar medications, Durysta can cause or worsen eye inflammation and should be used cautiously in patients with uveitis.
Iris Pigmentation: The implant can cause increased brown pigmentation of the iris, which is typically permanent.
Implant Migration: There is a risk of the implant moving to the back of the eye in patients with a damaged lens capsule.
European Withdrawal: The application for approval in Europe was withdrawn due to safety concerns regarding corneal cell loss and incomplete biodegradation with repeat use.

Durysta vs. traditional topical eye drops: A comparison


Feature	Durysta (Bimatoprost Implant)	Traditional Eye Drops (e.g., Lumigan)
Adherence	High. Administered once per eye, eliminating daily effort.	Variable. Dependent on the patient's daily routine and consistency.
IOP Consistency	High. Provides a steady, continuous release of medication.	Variable. Can lead to peaks and troughs in eye pressure throughout the day.
Duration of Effect	Sustained release over several months, with effects potentially lasting longer.	Requires daily, and sometimes multiple daily, administration.
Side Effects	Most common include eye redness, foreign body sensation, headache. Corneal cell loss is a key risk.	Can cause a variety of topical and systemic side effects, including cosmetic changes.
Delivery Method	Minimally invasive, in-office injection into the anterior chamber.	Self-administered topical drops applied to the surface of the eye.
Repeat Treatment	Limited to a single administration per eye, according to FDA approval.	Can be used as a long-term, ongoing treatment.

Conclusion

Yes, Durysta is FDA approved as of March 4, 2020, providing a novel treatment for adults with open-angle glaucoma or ocular hypertension. Its sustained-release mechanism offers advantages in terms of patient adherence and consistent intraocular pressure control compared to daily eye drops. However, the FDA limits its use to a single administration per eye due to risks, particularly corneal endothelial cell loss. Due to these risks, including concerns raised during the European review process, it is essential for patients to discuss whether Durysta is appropriate for their specific case with their ophthalmologist. This ensures that the potential benefits are carefully weighed against the risks as part of a long-term glaucoma management plan. The official FDA prescribing information online can provide further details.

Frequently Asked Questions

Yes, Durysta received FDA approval on March 4, 2020, for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The Durysta implant is designed to release medication over several months. Clinical studies showed IOP reduction lasting up to 15 weeks, though some patients experienced effects for a longer duration.

No. The FDA approved Durysta for a single administration per eye only, without retreatment, due to the risk of corneal endothelial cell loss.

The primary benefit is improved adherence, as it eliminates the need for daily eye drops. It also provides a more consistent, steady reduction in intraocular pressure.

The most common ocular side effect is conjunctival hyperemia (eye redness). Other common side effects include eye pain, foreign body sensation, blurred vision, and dry eye.

Durysta is contraindicated in patients with active eye infections, corneal endothelial cell dystrophy (like Fuchs’ Dystrophy), prior corneal transplants, or a ruptured posterior lens capsule.

Yes, like other bimatoprost products, Durysta can cause a gradual increase in the brown pigmentation of the iris. This change is likely to be permanent.

The application for European approval was withdrawn by the manufacturer due to safety concerns raised by the European Medicines Agency, specifically the risk of irreversible corneal endothelial cell loss with repeat dosing and incomplete biodegradation.