Aerie Pharmaceuticals pursues robust clinical development programs for its product candidates. In 17 completed trials (including AR-13324-CS103 and -CS205) of Rhopressa® (netarsudil ophthalmic solution) 0.02% (including the Phase 3 ROCKET studies) and Rocklatan® (netarsudil and 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). The netarsudil/latanoprost fixed-dose combination is now being studied in 13 European countries in MERCURY 3. A phase 2 clinical study with Rhopressa® is ongoing in Japan. Aerie has also initiated a Phase 2 study with its investigational retina product AR-1105 (Dexamethasone Intravitreal Implant) and expects to enter the clinic with a second investigational retina product, AR-13503 Sustained Release Implant, in the second quarter of 2019.
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 | Completed |
| 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 | Completed |
Rocklatan® (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 and Canada | 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 |
Retina Programs
| Identifier | Phase | Title | Indication | Study & Control Drugs | Location | Status |
|---|---|---|---|---|---|---|
| NCT 03739593 (AR-1105-CS201) |
2 | Study assessing AR-1105 in Subjects with Macular Edema due to Retinal Vain Occlusion (RVO) |
Macular Edema due to RVO | AR-1105-CF1 AR-1105-CF2 |
USA | Recruiting |
| NCT03835884 (AR-13503-CS201) |
1 | A Study Assessing AR-13503 Implant Alone and in Combination with Aflibercept in Subjects with nAMD or DME | nAMD DME |
AR-13503 Implant Low Dose AR-13503 Implant High DoseAR-13503 Implant Low Dose + Aflibercept AR-13503 Implant High Dose + Aflibercept AR-13503 Implant Low Dose + Sham AR-13503 Implant High Dose + Sham Sham + Aflibercept | USA | Recruiting |
