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Spotlight on DURYSTA®

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Glaucoma affects an estimated 76 million individuals worldwide and is a leading cause of blindness, with open-angle glaucoma (OAG) being the most prevalent form. Intraocular pressure (IOP) is the primary modifiable risk factor, and lowering IOP has been shown to reduce the risk of developing glaucoma in individuals with ocular hypertension (OHT).1

Topical ophthalmic medications are standard first-line therapy for OAG and OHT and are generally well tolerated with favorable systemic safety profiles. However, poor adherence to daily eye drop therapy is common and presents a significant clinical challenge, highlighting the need for treatments that provide sustained IOP reduction without reliance on daily administration.1,2

Durysta®: Implantable Medication Device

Durysta (bimatoprost implant; Allergan/AbbVie) was developed to address poor adherence in glaucoma management by eliminating the need for daily topical eye drops. Approved by the FDA in 2020, Durysta was the first intracameral, biodegradable, sustained-release implant containing 10 mcg of bimatoprost indicated to reduce IOP in patients with OAG or OHT.1,3

Efficacy Data

Durysta provided sustained IOP reduction over both short- and long-term follow-up across phase 3 and phase 3b studies.1,2,4-6

ARTEMIS

FDA approval was based on results from 2 multicenter, randomized, parallel-group, controlled, phase 3 ARTEMIS studies with a 20-month duration, including an 8-month extended follow-up period. These studies compared Durysta with twice-daily topical timolol maleate 0.5% in patients with OAG or OHT. ARTEMIS 1 enrolled 198 patients, and ARTEMIS 2 enrolled 176 patients.1,2,5

Durysta demonstrated IOP reductions ranging from 4.9 to 7.0 mmHg over 15 weeks in patients with a mean baseline IOP of 24.5 mmHg.4 In both ARTEMIS studies, Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period (see FIGURES 1 and 2).1,2

MORPHEUS

MORPHEUS was a multicenter, open-label, 12-month, phase 3b study involving 31 patients with OAG or OHT that evaluated the 24-hour IOP–lowering effect of Durysta at 8 weeks, as well as IOP-lowering efficacy and safety outcomes at 1 year. IOP measurements were obtained using pneumatonometry during sleep laboratory visits and Goldmann applanation tonometry during office visits. The primary endpoint was the hour-matched change from baseline in habitual-position IOP over 24 hours at week 8, as assessed by pneumatonometry.6

Pneumatonometry measurements obtained over 24 hours at week 8 demonstrated consistent IOP reduction throughout the day and night, with reduced IOP fluctuation. Additionally, most patients maintained reduced IOP for up to 1 year without the need for additional therapy. The estimated probability of not requiring rescue treatment in the study eye was:6

  • 84% at 120 days
  • 81% at 180 days
  • 74% at both 270 and 360 days

Safety and Tolerability

Safety data from pivotal studies demonstrated a consistent adverse event profile.1,2,5,6

In the ARTEMIS studies, the most common ocular adverse reaction was conjunctival hyperemia, reported in 27% of patients. Other common ocular adverse reactions, reported in 5% to 10% of patients, included foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, increased IOP, corneal endothelial cell loss, blurred vision, and iritis. The most common nonocular adverse event was headache, reported in 5% of patients.5

In the MORPHEUS study, the most common treatment-emergent adverse event (TEAE) was conjunctival hyperemia, observed in 35.5% of patients. Increased IOP was reported in 22.6% of patients. Other common TEAEs, reported in 6.5% to 9.7% of patients, included conjunctival hemorrhage, visual field defect, cataract, dry eye, foreign body sensation, punctate keratitis, and COVID-19.6

Treatment Administration

Durysta should not be re-administered in an eye that has previously received the implant. Durysta is supplied preloaded in a single-use applicator designed to deliver the biodegradable implant directly into the anterior chamber of the eye. Following administration, patients should be instructed to remain upright for at least 1 hour to allow appropriate implant positioning.1

For more information, visit https://www.durystahcp.com.

References

  1. Bacharach J, Tatham A, Ferguson G, et al; ARTEMIS 2 Study Group. Phase 3, randomized, 20-month study of the efficacy and safety of bimatoprost implant in patients with open-angle glaucoma and ocular hypertension (ARTEMIS 2). Drugs. 2021;81(17):2017-2033. doi:10.1007/s40265-021-01624-9
  2. Medeiros FA, Walters TR, Kolko M, et al; ARTEMIS 1 Study Group. Phase 3, randomized, 20-month study of bimatoprost implant in open-angle glaucoma and ocular hypertension (ARTEMIS 1). Ophthalmology. 2020;127(12):1627-1641. doi:10.1016/j.ophtha.2020.06.018
  3. 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. News release. Allergan. March 5, 2020. Accessed December 31, 2025. https://news.abbvie.com/index.php?s=2429&item=123527
  4. Medeiros FA, Sheybani A, Shah MM, et al. Single administration of intracameral bimatoprost implant 10 µg in patients with open-angle glaucoma or ocular hypertension. Ophthalmol Ther. 2022;11(4):1517-1537. doi:10.1007/s40123-022-00527-6
  5. DURYSTA. Package insert. AbbVie; 2024.
  6. Weinreb RN, Christie WC, Mederios FA, et al. Single administration of bimatoprost implant: effects on 24-hour intraocular pressure and 1-year outcomes. Ophthalmol Glaucoma. 2023;6(6):599-608. doi:10.1016/j.ogla.2023.06.007

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