The U.S. Food and Drug Administration (FDA) approved the DURYSTA™ bimatoprost implant for reducing intraocular pressure (IOP) on March 5, 2020. It is approved for patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).* The approval follows results from the two 20-month phase-3 clinical trials (ARTEMIS).

Manufactured by Allergan, a global pharmaceutical company based in Dublin, Ireland, Durysta is a prostaglandin analog. It is also the first commercially available sustained-release implant for lowering IOP that is intracameral (injected into the eye cavities) and biodegradable.

What were the results of the ARTEMIS clinical trials?

Phase 3 of the ARTEMIS clinical trials involved 1,122 participants with either OAG or OHT. Durysta was preloaded into a single-use applicator and administered directly into the anterior chamber (the space between the back of the cornea and front of the iris). During the 12-week primary efficacy period, Durysta decreased the patients’ IOP by approximately 30% from their baseline measurements. 

Due to certain contraindications and adverse effects, such as a relatively high risk of corneal decompensation, Durysta does come with certain warnings and safety measures. 

What are the contraindications?

Daystar should not be re-administered in an eye that has previously received Durysta treatment. The FDA limited Durysta to one administration because of a high rate of corneal decompensation that increased with subsequent doses during trials. 

It is also not recommended for patients with: 

• Active or suspected ocular or periocular (surrounding the eyeball) infections
• Corneal endothelial cell dystrophy 
• Prior corneal transplantation or endothelial cell transplants
• An absent or ruptured posterior lens capsule
• Hypersensitivity to bimatoprost or any other product components.

What possible adverse reactions are there?

Some of the most common adverse reactions reported by study participants included:

• Blurred vision
• Corneal decompensation requiring a corneal transplant
• Dilation and redness of conjunctival vessels (in the tissue lining the inner eyelid) 
• Dry eye
• Eye irritation and/or pain
• Headache
• Redness of conjunctival vessels
• Increased intraocular pressure
• Photophobia (sensitivity to light)
• Sensation of the presence of a foreign object in the eye

The current cost of the Durysta implant is about $2,000, plus the actual cost of the procedure. This is compared to Bimatoprost drops, costing approximately $1,200.00 per year.

What are the benefits of Durysta?

Eye drops are the current first-line treatment for glaucoma. While they are effective, nearly 80% of patients have trouble either placing a single drop on their eye or remembering to instill their drops. Poor adherence can result in disease progression, continued vision loss, and the potential need for invasive treatments such as surgery.

Durysta may also help patients who are unable to insert drops on their own or require a friend to help them. It also eliminates the need for patients to remember to take their drops, as many do.

“Today’s FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options,” said Allergan’s Chief Research and Development Officer David Nicholson.

It’s important to realize that any object placed into the eye creates at least a small risk of infection, which can lead to permanent vision loss. 

*AbbVie. (2020, Mar. 5). Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracameral Biodegradable Sustained-Release Implant to lower Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension Patients [Press Release]. https://news.abbvie.com/news/allergan-press-releases/allergan-receives-fda-approval-for-durysta-bimatoprost-implant-first-and-only-intracameral-biodegradable-sustained-release-implant-to-lower-intraocular-pressure-in-open-angle-glaucoma-or-ocular-hypertension-patients.htm

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