Aerie Pharmaceuticals pursues robust clinical development programs for its product candidates. In 17 clinical trials of Rhopressa® (netarsudil ophthalmic solution) 0.02% (including AR-13324-CS103 and -CS205 and the Phase 3 ROCKET studies) and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% (including the Phase 3 MERCURY 1 and 2 studies) completed to date, more than 2,600 subjects received at least one dose of the study medication (either netarsudil or netarsudil/latanoprost). The netarsudil/latanoprost fixed-dose combination has also been studied in 13 European countries in MERCURY 3. Positive topline results from a Phase 3 clinical study of netarsudil ophthalmic solution 0.02% in Japan were reported in October 2021. Aerie has also reported topline data from a Phase 2 study with its investigational retina product AR-1105 (Dexamethasone Intravitreal Implant) and is currently completing first in human clinical evaluation of a second investigational retina product, AR-13503 Sustained Release Implant. The topline results from the large Phase 2b COMET-1 study of AR-15512, Aerie’s investigational TRPM8 agonist eye drop, in dry eye disease were reported in September 2021.
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 |
| NCT04620135 (AR-13324-CS305) |
3 | Safety and Efficacy Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Subjects with Open Angle Glaucoma or Ocular Hypertension | OAG/OHT | Netarsudil ophthalmic solution 0.02% Ripasudil hydrochloride hydrate ophthalmic solution 0.4% |
Japan | 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 | Completed |
| NCT 05283395 (MA-ROC-22-003) | 4 | A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension | OAG/OHT | Netarsudil 0.02%/Latanoprost 0.005% | USA | Recruiting |
Retina Programs
| Identifier | Phase | Title | Indication | Study & Control Drugs | Location | Status |
|---|---|---|---|---|---|---|
| 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 |
| 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 | Completed |
Dry Eye Programs
| Identifier | Phase | Title | Indication | Study & Control Drugs | Location | Status |
|---|---|---|---|---|---|---|
| COMET-1
NCT04498182 (AR-15512-CS201) |
2b | A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1) | Dry Eye Disease | AR-15512 Vehicle |
USA | Completed |
| COMET-2
NCT 05285644 (AR-15512-CS301) |
3 | A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-2) | Dry Eye Disease | 0.003% AR-15512 vs Vehicle | USA | Recruiting |
| COMET-3
NCT 05285644 (AR-15512-CS301) |
3 | A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3) | Dry Eye Disease | 0.003% AR-15512 vs Vehicle | USA | Active; not yet recruiting |
