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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.1-3


Nearly twice as many Rocklatan patients achieved a 30% reduction in IOP compared to latanoprost patients4

Pooled MERCURY studies: Patients reaching prespecified IOP reduction (%) from baseline at month 3 (intent-to-treat population)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 patients4

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)4

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®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


Rocklatan safety information and side effects

The majority of ocular adverse events were mild and tolerable1,4

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

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

Conjunctival hyperemia1,4,6

  • Nearly 20% of patients had hyperemia at baseline.
  • 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

Corneal verticillata1,4,6

  • 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 hemorrhage6

  • 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

  • Pigmentation changes
  • Eyelash changes
  • Intraocular inflammation
  • Macular edema
  • Herpetic keratitis
  • Bacterial keratitis
  • Contact lens wear

Adverse reactions

Rocklatan: The most common ocular adverse reaction is conjunctival hyperemia (59%). Five percent of patients discontinued therapy due to conjunctival hyperemia. Other common ocular adverse reactions were: 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.

Netarsudil 0.02%: Instillation site erythema, corneal staining, increased lacrimation and erythema of eyelid.

Latanoprost 0.005%: Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of the iris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid, upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema, myalgia/arthralgia/back pain, and rash/allergic reaction.

Please click here for full prescribing information for Rocklatan.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE

Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is approved 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.


IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

  • Pigmentation changes
  • Eyelash changes
  • Intraocular inflammation
  • Macular edema
  • Herpetic keratitis
  • Bacterial keratitis
  • Contact lens wear

Adverse reactions

Rocklatan: The most common ocular adverse reaction is conjunctival hyperemia (59%). Five percent of patients discontinued therapy due to conjunctival hyperemia. Other common ocular adverse reactions were: 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.

Netarsudil 0.02%: Instillation site erythema, corneal staining, increased lacrimation and erythema of eyelid.

Latanoprost 0.005%: Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of the iris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid, upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema, myalgia/arthralgia/back pain, and rash/allergic reaction.

Please click here for full prescribing information for Rocklatan.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE

Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is approved 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.

References:

  1. Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Prescribing Information, Aerie Pharmaceuticals, Inc., Irvine, Calif. 2019.
  2. Asrani S, McKee H, Scott B, et al. Pooled phase 3 efficacy 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 Biennial Meeting of the European Glaucoma Society, March 2018.
  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.