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In the MERCURY-1 (12-month study) and MERCURY-2 (3-month study) phase 3 trials in patients with open angle glaucoma and ocular hypertension, the IOP-lowering effect of once-daily Rocklatan® was compared to latanoprost QD and Rhopressa® QD. The primary efficacy endpoint was LS mean IOP through Month 3. Rocklatan® was statistically superior to latanoprost and Rhopressa® at all 9 time points and maintained superiority over the 12-month study.1,2


Nearly twice as many Rocklatan® patients achieved a 30% reduction in IOP compared to latanoprost patients2,4

Pooled MERCURY studies: Patients reaching prespecified IOP reduction (%) from baseline at month 3 (intent-to-treat population)2,4

Patients reaching prespecified IOP reduction (%) from baseline at month 3 (intent-to-treat population) Patients reaching prespecified IOP reduction (%) from baseline at month 3 (intent-to-treat population)

3x as many Rocklatan® patients achieved an IOP reduction of 40% or more vs latanoprost patients2,4

See full study design

MERCURY-1 and MERCURY-2 study design

MERCURY-1 (12-month) and MERCURY-2 (3-month) were double-masked, randomized, multicenter, active-controlled, parallel-group, phase 3 studies of Rocklatan®, Rhopressa® and latanoprost.3,5

Inclusion criteria:

  • Age ≥18 years
  • Bilateral OAG or OHT
  • Unmedicated IOP (post-washout*):
  • >20 to <36 mmHg at 8:00 AM
  • >17 to <36 mmHg at 10:00 AM and 4:00 PM

MERCURY-1 (12-month duration, US only, ITT population)3

Rocklatan® QD (n=238)

Latanoprost QD (n=236)

Rhopressa® QD (n=244)

MERCURY-2 (3-month duration, US and Canada, ITT population)5

Rocklatan® QD (n=245)

Latanoprost QD (n=250)

Rhopressa® QD (n=255)

Primary Efficacy Endpoints:

  • Mean IOP at nine time points (8:00 AM, 10:00 AM, 4:00 PM at Week 2, Week 6, and Month 3)2

The minimum washout period was 4 weeks for patients using prostaglandin analogs or beta-adrenoceptor antagonists prior to study entry, 2 weeks for those using adrenergic agonists, and 5 days for those using muscarinic agonists or carbonic anhydrase inhibitors.5,6


Nearly 60% of Rocklatan® patients achieved an IOP of ≤16 mmHg vs 37% of latanoprost patients2

Pooled MERCURY studies: Proportion of patients achieving prespecified target mean IOP (mmHg) at month 3 (intent-to-treat population)2

Proportion of patients achieving prespecified target mean IOP (mmHg) at month 3 (intent-to-treat population) Proportion of patients achieving prespecified target mean IOP (mmHg) at month 3 (intent-to-treat population)
  • Nearly 3x as many Rocklatan® patients achieved and sustained target IOPs ≤14 mmHg vs those taking latanoprost2

Clinical significance is not known.

See full study design

MERCURY-1 and MERCURY-2 study design

MERCURY-1 (12-month) and MERCURY-2 (3-month) were double-masked, randomized, multicenter, active-controlled, parallel-group, phase 3 studies of Rocklatan®, Rhopressa® and latanoprost.3,5

Inclusion criteria:

  • Age ≥18 years
  • Bilateral OAG or OHT
  • Unmedicated IOP (post-washout*):
  • >20 to <36 mmHg at 8:00 AM
  • >17 to <36 mmHg at 10:00 AM and 4:00 PM

MERCURY-1 (12-month duration, US only, ITT population)3

Rocklatan® QD (n=238)

Latanoprost QD (n=236)

Rhopressa® QD (n=244)

MERCURY-2 (3-month duration, US and Canada, ITT population)5

Rocklatan® QD (n=245)

Latanoprost QD (n=250)

Rhopressa® QD (n=255)

Primary Efficacy Endpoints:

  • Mean IOP at nine time points (8:00 AM, 10:00 AM, 4:00 PM at Week 2, Week 6, and Month 3)2

The minimum washout period was 4 weeks for patients using prostaglandin analogs or beta-adrenoceptor antagonists prior to study entry, 2 weeks for those using adrenergic agonists, and 5 days for those using muscarinic agonists or carbonic anhydrase inhibitors.5,6


Rocklatan® achieved statistical superiority over latanoprost at EVERY measured timepoint1,2

In MERCURY-1 and MERCURY-2 phase 3 trials, the IOP-lowering effects of Rocklatan® were superior to each of its individual active components at all 9 time points between Week 2 and Month 3.

Pooled MERCURY studies: Mean IOP over 3 months (intent-to-treat population)2

Mean IOP over 3 months (intent-to-treat population) Mean IOP over 3 months (intent-to-treat population)

The least square mean IOP at each post-baseline time point was derived using an analysis of covariance adjusted for baseline IOP using Monte Carlo Markov Chain for imputation of missing data for all randomized subjects.

The difference in LS mean IOP was up to 3 mmHg vs latanoprost or Rhopressa®2

See full study design

MERCURY-1 and MERCURY-2 study design

MERCURY-1 (12-month) and MERCURY-2 (3-month) were double-masked, randomized, multicenter, active-controlled, parallel-group, phase 3 studies of Rocklatan®, Rhopressa® and latanoprost.3,5

Inclusion criteria:

  • Age ≥18 years
  • Bilateral OAG or OHT
  • Unmedicated IOP (post-washout*):
  • >20 to <36 mmHg at 8:00 AM
  • >17 to <36 mmHg at 10:00 AM and 4:00 PM

MERCURY-1 (12-month duration, US only, ITT population)3

Rocklatan® QD (n=238)

Latanoprost QD (n=236)

Rhopressa® QD (n=244)

MERCURY-2 (3-month duration, US and Canada, ITT population)5

Rocklatan® QD (n=245)

Latanoprost QD (n=250)

Rhopressa® QD (n=255)

Primary Efficacy Endpoints:

  • Mean IOP at nine time points (8:00 AM, 10:00 AM, 4:00 PM at Week 2, Week 6, and Month 3)2

The minimum washout period was 4 weeks for patients using prostaglandin analogs or beta-adrenoceptor antagonists prior to study entry, 2 weeks for those using adrenergic agonists, and 5 days for those using muscarinic agonists or carbonic anhydrase inhibitors.5,6


Rocklatan® safety information and side effects

The majority of ocular adverse events were mild and tolerable1,2

The most common ocular adverse event (AE) in controlled clinical studies with Rocklatan® was conjunctival hyperemia, which was reported in 59% of patients.1,2

Other common ocular AE’s reported include instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%).1,2

Conjunctival hyperemia1,2

  • 59% of patients experienced conjunctival hyperemia.
  • ˜90% of patients who experience conjunctival hyperemia report it as mild, and the severity did not increase over time.
  • ˜80% of patients who experience conjunctival hyperemia report it as sporadic or intermittent.
  • 5% of patients discontinued due to conjunctival hyperemia.
Conjunctival hyperemia graph
  • Nearly 20% of patients had hyperemia at baseline via biomicroscopy.

Corneal verticillata1,2

  • 15% of patients experienced corneal verticillata, but the reaction did not result in any apparent visual functional changes.
  • 1% of patients discontinued due to corneal verticillata.

Conjunctival hemorrhage2

  • Graded as mild in all but one Rocklatan®-treated patient (98%)—and no patients discontinued Rocklatan® due to conjunctival hemorrhage.
Please see full Prescribing Information for additional safety information

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur. Iris pigmentation likely to be permanent.

Gradual change to eyelashes may include increased length, thickness, number, and misdirected growth of lashes. Usually reversible upon discontinuation of treatment.

Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). Should generally not be used in patients with active intraocular inflammation.

Macular edema, including cystoid macular edema, has been reported with latanoprost. Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with known risk factors for macular edema.

Use with caution in patients with a history of herpetic keratitis. Avoid use in cases of active herpes simplex keratitis.

Bacterial keratitis has been reported with multiple-dose containers of topical ophthalmic products inadvertently contaminated by patients.

Remove contact lenses prior to administration and reinsert 15 minutes after administration.

Adverse reactions

The most common ocular adverse reactions were conjunctival hyperemia (59%), with 5% of patients discontinuing therapy for this reason, instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% of patients.

INDICATIONS AND USAGE

Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. The dosage of Rocklatan® should not exceed once daily. Rocklatan® may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Please click here for full prescribing information for Rocklatan® Solution

To report Suspected Adverse Reactions, contact Aerie Pharmaceuticals, Inc. at 1-855-740-1924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur. Iris pigmentation likely to be permanent.

Gradual change to eyelashes may include increased length, thickness, number, and misdirected growth of lashes. Usually reversible upon discontinuation of treatment.

Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). Should generally not be used in patients with active intraocular inflammation.

Macular edema, including cystoid macular edema, has been reported with latanoprost. Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with known risk factors for macular edema.

Use with caution in patients with a history of herpetic keratitis. Avoid use in cases of active herpes simplex keratitis.

Bacterial keratitis has been reported with multiple-dose containers of topical ophthalmic products inadvertently contaminated by patients.

Remove contact lenses prior to administration and reinsert 15 minutes after administration.

Adverse reactions

The most common ocular adverse reactions were conjunctival hyperemia (59%), with 5% of patients discontinuing therapy for this reason, instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% of patients.

INDICATIONS AND USAGE

Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. The dosage of Rocklatan® should not exceed once daily. Rocklatan® may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Please click here for full prescribing information for Rocklatan® Solution

To report Suspected Adverse Reactions, contact Aerie Pharmaceuticals, Inc. at 1-855-740-1924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References:

  1. Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Prescribing Information, Aerie Pharmaceuticals, Inc., Irvine, Calif. 2020.
  2. Asrani, S., Bacharach, J., Holland, E. et al. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther 37, 1620–1631 (2020).
  3. Brubaker J, Teymoorian S, Lewis R, et al. Once-daily fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension/open-angle glaucoma: 12-month data from MERCURY-1. Presented at the 28th Meeting of the American Glaucoma Society, March 2018.
  4. Data on file, Aerie Pharmaceuticals, Inc.
  5. Walters T, Ahmed I, Lewis R, et al. Once-daily fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension or open-angle glaucoma, the MERCURY-2 study. Presented at the 28th Meeting of the American Glaucoma Society, March 2018.
  6. Bacharach J, Holland E, Sheng H, et al. Pooled safety analysis of a once-daily fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension and open-angle glaucoma. Presented at the 13th Meeting of the European Glaucoma Society, May 2018.