CLINICAL DATA

DURYSTA^® is a powerful IOP-lowering therapy
for patients with OAG or OHT.

In clinical studies, DURYSTA^® demonstrated an IOP reduction of approximately 5 to 8 mm Hg in patients with a mean baseline IOP of 24.5 mm Hg.
Please see below for additional details.

EFFICACY DATA: ARTEMIS 1 AND 2 (PIVOTAL STUDIES)

Most DURYSTA® participants in the pivotal trials had mild OAG or OHT in early disease.^1,2

Study Design^1-3

Efficacy was evaluated in 2 multicenter, randomized, parallel-group, controlled, 20-month (including 8-month extended follow-up) studies of DURYSTA^® compared to twice-daily topical timolol 0.5% drops in patients with OAG or OHT. IOP values obtained after initiation of nonstudy IOP-lowering treatment were excluded from the analysis.

Key exclusion criteria^3,4

History of narrow angle (Shaffer grade < 3)
Nonresponsive to topical beta-blockers and/or PGAs therapy
Peripheral anterior synechiae in the inferior iridocorneal angle on gonioscopic examination at screening in either eye
History or evidence of complicated cataract surgery or phakic IOL insertion
Contraindications to beta-blocker therapy

Key inclusion criteria3,4

Patients ≥ 18 years of age with a diagnosis of OAG or OHT in each eye and both eyes requiring IOP-lowering treatment
Study eye inferior iridocorneal angle Shaffer grade angle of ≥ 3 on gonioscopy and peripheral anterior chamber depth of ≥ 1/2 corneal thickness by Van Herick estimation
Central corneal endothelial cell density by specular microscopy of ≥ 1800 cells/mm² in at least 1 eye

ARTEMIS 1 ARTEMIS 1

ARTEMIS 2 ARTEMIS 2

APPROXIMATELY 5 to 8 mm Hg mean IOP reduction over 15 weeks in
patients with a mean baseline IOP of 24.5 mm Hg¹

Most common adverse reactions

Ocular

The most common ocular adverse reaction was conjunctival hyperemia, which occurred in 27% of patients. Other common ocular adverse reactions reported in 5% to 10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, IOP increased, corneal endothelial cell loss, vision blurred, and iritis¹

Nonocular

The most common nonocular adverse event was headache, which was observed in 5% of patients¹

ADDITIONAL DATA: MORPHEUS PHASE 3B SLEEP STUDY

Study Design⁵

The MORPHEUS study was a multicenter, open-label, noncomparative, phase 3B sleep lab study. Participants (N = 31) were administered a single DURYSTA^® in study eye on Day 1. Study participants were nonsmoker adults with OAG or OHT, an open iridocorneal angle, and baseline IOP after washout of 22 to 34 mm Hg by GAT in at least 1 eye (the study eye). A Reichert Model 30 pneumatonometer was used when IOP measurements were collected at sleep lab visits and a GAT was used when IOP measurements were collected at office visits. While rescue IOP-lowering treatment could be initiated at the investigator’s discretion, IOP measurements were evaluated in study eyes that had not been rescued.

Primary endpoint⁵

Hour-matched change from baseline in habitual position IOP over 24 hours at Week 8 after being assessed with pneumatonometry

Secondary endpoint⁵

Change from baseline in range of IOP in eyes treated with DURYSTA® at the Week 8 sleep lab visit

Other endpoint⁵

Time to initial use of nonstudy IOP-lowering treatment

Study Limitations⁵

Small number of subjects (N = 31) is not powered for statistical significance
Nonrandomized, single-arm, unmasked study may introduce bias related to overall treatment effect. Interpret data with caution

Data limitations: There are no statistical hypotheses defined in the protocol for the study. Analysis results are based on descriptive statistics; therefore, no statistical conclusion can be drawn from this study.

PRIMARY ENDPOINT

24-Hour Habitual IOP Curve at Baseline and Week 8⁵

SECONDARY ENDPOINT

Range in Habitual IOP Over 24 Hours⁵

The secondary outcome measure was change from baseline in range of IOP in eyes treated with DURYSTA® at the week 8 sleep lab visit⁵
Habitual position IOP was measured using the range of habitual position IOP values for each participant collected from the sleep lab visit during the diurnal/wake period (8 am-10 pm), the nocturnal/sleep period (12 am-6 am), and the entire 24-hour period (8 am-6 am)⁵

OTHER ENDPOINT: TIME TO RESCUE

Probability of Not Requiring Rescue IOP-Lowering Treatment⁵

Additional Considerations

The registrational trials that helped to support the FDA approval (ARTEMIS 1 and 2) demonstrated IOP reduction with DURYSTA® through 15 weeks.¹ Additionally, the biodegradable implant releases medication for several months²; therefore, continued IOP monitoring is needed

Safety Data

The most common TEAE was conjunctival hyperemia (incidence 35.5%, 11/31)⁵
Intraocular pressure increased was reported in 22.6% (7/31) of cases⁵
Other most common TEAEs reported in 6.5% to 9.7% of cases were conjunctival hemorrhage, visual field defect, cataract, dry eye, foreign body sensation in eye, punctate keratitis, and COVID-19⁵

Learn how DURYSTA^®
works for several
months

About DURYSTA®

Where DURYSTA^®
may fit in the
treatment paradigm

When to Use

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Resources

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BID = twice per day; OAG = open-angle glaucoma; OHT = ocular hypertension; PGA = prostaglandin analog; GAT = Goldmann application tonometer; TEAE = treatment-emergent adverse events.

References: 1. DURYSTA® Prescribing Information. 2. 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. 3. 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. 4. 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. 5. 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.

Important Safety Information

Contraindications

DURYSTA is contraindicated in patients with: active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy); prior corneal transplantation or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; hypersensitivity to bimatoprost or to any other components of the product.

Warnings and Precautions

The presence of DURYSTA implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration of DURYSTA should be limited to a single implant per eye without retreatment. Caution should be used when prescribing DURYSTA in patients with limited corneal endothelial cell reserve.

DURYSTA should be used with caution in patients with narrow iridocorneal angles (Shaffer grade <3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.

Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic bimatoprost, including DURYSTA intracameral implant. DURYSTA should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Prostaglandin analogs, including DURYSTA, have been reported to cause intraocular inflammation. DURYSTA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Ophthalmic bimatoprost, including DURYSTA intracameral implant, has been reported to cause changes to pigmented tissues, such as increased pigmentation of the iris. Pigmentation of the iris is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. While treatment with DURYSTA can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Intraocular surgical procedures and injections, including DURYSTA, have been associated with endophthalmitis. Proper aseptic technique must always be used with administering DURYSTA, and patients should be monitored following the administration.

Adverse Reactions

In controlled studies, the most common ocular adverse reaction reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions reported in 5%-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, iritis, and headache.

Please see accompanying full Prescribing Information, or visit https://www.rxabbvie.com/pdf/durysta_pi.pdf.

US-DUR-250116

Important Safety Information

Contraindications

Warnings and Precautions

DURYSTA should be used with caution in patients with narrow iridocorneal angles (Shaffer grade <3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.

Adverse Reactions

Please see accompanying full Prescribing Information, or visit https://www.rxabbvie.com/pdf/durysta_pi.pdf.

US-DUR-250116

CLINICAL DATA

EFFICACY DATA: ARTEMIS 1 AND 2 (PIVOTAL STUDIES)

Most DURYSTA® participants in the pivotal trials had mild OAG or OHT in early disease.^1,2

APPROXIMATELY 5 to 8 mm Hg mean IOP reduction over 15 weeks in
patients with a mean baseline IOP of 24.5 mm Hg¹

Ocular

Nonocular

ADDITIONAL DATA: MORPHEUS PHASE 3B SLEEP STUDY

Learn how DURYSTA^®
works for several
months

Where DURYSTA^®
may fit in the
treatment paradigm

Access DURYSTA^®
resources for your
practice

Start the DURYSTA^® ordering process
today

Indications and Usage

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

Contraindications

Contraindications

Contraindications

Contraindications

Indications and Usage

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

CLINICAL DATA

EFFICACY DATA: ARTEMIS 1 AND 2 (PIVOTAL STUDIES)

Most DURYSTA® participants in the pivotal trials had mild OAG or OHT in early disease.1,2

APPROXIMATELY 5 to 8 mm Hg mean IOP reduction over 15 weeks in patients with a mean baseline IOP of 24.5 mm Hg1

Ocular

Nonocular

ADDITIONAL DATA: MORPHEUS PHASE 3B SLEEP STUDY

Learn how DURYSTA® works for several months

Where DURYSTA® may fit in the treatment paradigm

Access DURYSTA® resources for your practice

Start the DURYSTA® ordering process today

Indications and Usage

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

Contraindications

Contraindications

Contraindications

Contraindications

Indications and Usage

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

Most DURYSTA® participants in the pivotal trials had mild OAG or OHT in early disease.^1,2

APPROXIMATELY 5 to 8 mm Hg mean IOP reduction over 15 weeks in
patients with a mean baseline IOP of 24.5 mm Hg¹

Learn how DURYSTA^®
works for several
months

Where DURYSTA^®
may fit in the
treatment paradigm

Access DURYSTA^®
resources for your
practice

Start the DURYSTA^® ordering process
today