Aerie Pharmaceuticals Logo

Clinical Trials

Aerie Pharmaceuticals pursues robust clinical development programs for its product candidates. In 15 Aerie-sponsored North American clinical trials of Rhopressa® (netarsudil ophthalmic solution) 0.02% (including the Phase 3 ROCKET studies) and Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% (including the Phase 3 MERCURY studies) completed to date, more than 2,600 subjects have had at least one dose of the study medication (either netarsudil or netarsudil/latanoprost). Roclatan™ is now being studied in 11 European countries in MERCURY 3. Late stage clinical studies with Rhopressa® are also being planned in Japan. In 2019, Aerie Pharmaceuticals expects to enter the clinic with its two lead retina programs.

All completed and currently enrolling clinical studies are summarized in the table below. More details on these protocols, including final results when available, can be accessed through the ClinicalTrials.gov website.

Rhopressa® (Netarsudil - AR-13324) Studies

Identifier Phase Title Indication Study & Control Drugs Location Status
NCT 01997879
(AR-13324-CS101)
1 An Open-Label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of AR‑13324 Ophthalmic Solution 0.02% in Healthy Volunteers Healthy subjects Netarsudil 0.02%

QD (AM)

USA Completed
NCT02406287
(AR-13324-CS102)
1 A Double-Masked, Randomized, Paired-Comparison, Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution 0.02% in Healthy Volunteers Healthy subjects Netarsudil 0.02%
(1 eye)
Placebo
(contralateral eye)

QD (AM)

USA Completed
AR-13324-CS104 1 A Prospective, Double-Masked, Randomized, Multi-Center, Placebo‑Controlled, Parallel-Group Study Assessing the Safety of Two Concentrations of Netarsudil Ophthalmic Solution in Healthy Japanese/Japanese‑American Volunteers in the United States Healthy subjects Netarsudil 0.02%
Netarsudil 0.04%
Placebo

QD (AM)

USA Completed
NCT01528787
(AR-13324-CS201)
2 A Phase 2, Double-Masked, Randomized, Placebo-Controlled Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of AR-13324 Ophthalmic Solution in Patients with Elevated Intraocular Pressure Open-Angle Glaucoma (OAG)/Ocular Hypertension (OHT) Netarsudil 0.01%
Netarsudil 0.02%
Netarsudil 0.04%
Placebo

QD (AM)

USA Completed
NCT01731002
(AR-13324-CS202)
2 A Phase 2, Double-Masked, Randomized, Multi-Center, Active-Controlled, Dose-Response, Parallel-Group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.01%
Netarsudil 0.02%
Latanoprost 0.005%

QD (PM)

USA Completed
NCT02874846
(AR-13324-CS204)
2 A Double-Masked, Randomized, Placebo-Controlled Study of the Nocturnal and Diurnal IOP-Lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-Hour Period OAG/OHT Netarsudil 0.02%
Placebo

QD (PM)

USA Completed
NCT03310580
(AR-13324-CS205)
2 A Prospective, Double-Masked, Randomized, Multi-Center, Placebo-Controlled, Parallel-Group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects with Open-Angle Glaucoma or Ocular Hypertension OAG/OHT Netarsudil 0.02%
Netarsudil 0.04%
Placebo

QD (AM)

USA Recruiting
NCT03233308
(AR-13324-CS206)
2 A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment with Netarsudil Ophthalmic Solution in Subjects with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%
Placebo

QD (AM)

USA Completed
ROCKET 1
NCT02207491
(AR-13324-CS301)
3 A Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel, 3-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution 0.02% Compared to Timolol Maleate Ophthalmic Solution 0.5% in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%
QD (PM)

Timolol 0.5% BID

USA Completed
ROCKET 2
NCT02207621
(AR-13324-CS302)
3 A Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel, 12-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution 0.02% QD and BID Compared to Timolol Maleate Ophthalmic Solution 0.5% BID in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%
QD (PM)

Netarsudil 0.02%
BID

Timolol 0.5% BID

USA Completed
ROCKET 3
NCT02246764
(AR-13324-CS303)
3 A Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel, 12-Month Study Assessing the Safety of AR-13324 Ophthalmic Solution 0.02% QD and BID Compared to Timolol Maleate Ophthalmic Solution 0.5% BID in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%
QD (PM)

Netarsudil 0.02%
BID

Timolol 0.5% BID

Canada Completed
ROCKET 4
NCT02558374
(AR-13324-CS304)
3 A Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel Group, 6-Month Study with a 3-Month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution 0.02% QD Compared to Timolol Maleate Ophthalmic Solution 0.5% BID in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%
QD (PM)

Timolol 0.5% BID

USA Completed
AR-13324-OBS01 3 A Prospective, Targeted, Non-Interventional (Observational) Study of Subjects Who Developed Corneal Deposits in Clinical Trials AR-133324-CS301 and AR-13324-CS302 Includes Subjects With Corneal Verticillata from AR-13324-CS302 None
(Non-Interventional)
USA Complete

Roclatan (Netarsudil/Latanoprost FDC - PG324) Studies

Identifier Phase Title Indication Study & Control Drugs Location Status
NCT02057575
(PG324-CS201)
2 A Double-Masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution 0.01% and PG324 Ophthalmic Solution 0.02% Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005 in Patients with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.01%/Latanoprost 0.005%

Netarsudil 0.02%/Latanoprost 0.005%

Netarsudil 0.02%Latanoprost 0.005%

QD (PM)

USA Completed
Mercury 1
NCT02558400
(PG324-CS301)
3 A Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel-Group 12-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%/Latanoprost 0.005%

Netarsudil 0.02%

Latanoprost 0.005%

QD (PM)

USA Completed
Mercury 2
NCT02674854
(PG324-CS302)
3 A Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel-Group 3-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%/Latanoprost 0.005%

Netarsudil 0.02%

Latanoprost 0.005%

QD (PM)

USA Completed
Mercury 3
NCT03284853
(PG324-CS303)
3 A Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel-Group 6-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03%/Timolol 0.5%) Ophthalmic Solution in Subjects with Elevated Intraocular Pressure OAG/OHT Netarsudil 0.02%/Latanoprost 0.005%

Ganfort

QD (PM)

Europe Recruiting