CLINICAL TRIALS PROFILE FOR RHOPRESSA

All Clinical Trials for RHOPRESSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04981886 ↗	Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma	Not yet recruiting	Salus University	Phase 4	2021-08-01	Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH. Hypotheses - Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG. - Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG. - Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.
NCT04051463 ↗	Rhopressa for Corneal Edema Associated With Fuchs Dystrophy	Completed	Price Vision Group	Phase 2/Phase 3	2019-08-05	The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.
NCT03971357 ↗	Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration	Terminated	Cornea Research Foundation of America	Phase 2/Phase 3	2019-07-22	Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
NCT03971357 ↗	Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration	Terminated	Price Vision Group	Phase 2/Phase 3	2019-07-22	Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
NCT03808688 ↗	Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting	Completed	Aerie Pharmaceuticals	Phase 4	2018-12-27	To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.

Clinical Trial Conditions for RHOPRESSA

Condition Name

Condition Name for RHOPRESSA
Intervention	Trials
Proliferative Vitreoretinopathy	2
Rhegmatogenous Retinal Detachment	2
Normal Tension Glaucoma	1
Ocular Hypertension	1

Condition MeSH

Condition MeSH for RHOPRESSA
Intervention	Trials
Retinal Detachment	2
Glaucoma	2
Fuchs' Endothelial Dystrophy	2
Vitreoretinopathy, Proliferative	2

Clinical Trial Locations for RHOPRESSA

Trials by Country

+

−

Trials by Country for RHOPRESSA
Location	Trials
United States	18

Trials by US State

+

−

Trials by US State for RHOPRESSA
Location	Trials
Indiana	2
Pennsylvania	2
New York	1
Wisconsin	1
Texas	1

Clinical Trial Progress for RHOPRESSA

Clinical Trial Phase

Clinical Trial Phase for RHOPRESSA
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for RHOPRESSA
Clinical Trial Phase	Trials
Not yet recruiting	3
Completed	2
Terminated	1

Clinical Trial Sponsors for RHOPRESSA

Sponsor Name

Sponsor Name for RHOPRESSA
Sponsor	Trials
Price Vision Group	2
Aerie Pharmaceuticals	1
Cornea Research Foundation of America	1

Sponsor Type

Sponsor Type for RHOPRESSA
Sponsor	Trials
Other	4
Industry	3

Rhopressa: Clinical Trials, Market Analysis, and Projections

Introduction to Rhopressa

Rhopressa, also known as netarsudil ophthalmic solution, is a groundbreaking medication developed by Aerie Pharmaceuticals for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Here, we will delve into the clinical trials, market analysis, and future projections for this innovative drug.

Clinical Trials Overview

Phase 3 Clinical Trials in Japan

Aerie Pharmaceuticals has made significant progress in its clinical trials for Rhopressa in Japan. The first Phase 3 clinical trial, which began in December 2020, has completed enrollment with 245 patients randomized across the netarsudil and ripasudil treatment arms. This study is designed to evaluate the ocular hypotensive efficacy and safety of netarsudil once daily compared to ripasudil twice daily over a 4-week period in patients with primary open-angle glaucoma or ocular hypertension[1].

Study Design and Objectives

The trial is a randomized, single-masked, multi-center, parallel-group study. The netarsudil arm involves administering a netarsudil drop in the evening and a netarsudil ophthalmic solution vehicle in the morning to maintain the masking of the trial. The ripasudil arm is administered twice a day, consistent with its product labeling in Japan. The study aims to support a potential regulatory submission of netarsudil ophthalmic solution in Japan, adhering to the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)[1].

Collaboration with Santen Pharmaceutical Co., Ltd.

Aerie Pharmaceuticals and Santen Pharmaceutical Co., Ltd. have an exclusive collaboration and license agreement for Rhopressa and Rocklatan in Japan and several other Asian countries. Santen is responsible for all development and commercialization costs and activities in these territories, but both companies are co-funding the first Phase 3 study for Rhopressa in Japan[1].

Clinical Trial Results and Safety Profile

Previous Phase 3 Trials

In previous Phase 3 trials conducted in the United States, Rhopressa demonstrated its efficacy in reducing intraocular pressure. For instance, in the Rocket 1 trial, Rhopressa did not demonstrate noninferiority to timolol for the primary endpoint range of above 20 mm Hg to below 27 mm Hg but did show noninferiority at all ranges below 26 mm Hg. Common adverse events included hyperemia (redness), discomfort with drug administration, and conjunctival hemorrhage, typically mild petechiae at the limbus[3][4].

Safety and Tolerability

Despite the initial concerns about redness, clinical experience has shown that the redness issues are less severe than expected from clinical trial data. Dr. Aref noted that patients can tolerate the agent better when informed about the potential for some degree of redness that typically wanes over the first few weeks of therapy[4].

Market Analysis and Projections

Ocular Hypertension Market Outlook

The ocular hypertension market is expected to grow significantly, driven by increasing incidences of scarring, inflammation, or structural abnormalities in the eye that impair the proper outflow of aqueous humor. The market size is projected to reach USD 4,538.6 million by 2034, growing at a CAGR of 3.67% from 2024 to 2034[2].

Role of Rhopressa in the Market

Rhopressa, with its novel mechanism of action as a Rho kinase inhibitor, improves fluid outflow through the trabecular meshwork and reduces episcleral venous pressure. This makes it an effective and innovative approach to managing ocular hypertension. The drug's inclusion in the market is expected to contribute to the growth, particularly with advancements in diagnostic technologies and sustained-release drug delivery systems that enhance patient compliance and therapeutic outcomes[2].

Global Market Trends

The global market for glaucoma treatment, which includes ocular hypertension, is also seeing significant growth. Novel drug delivery systems, such as sustained-release implants and micro-dosing technologies, are transforming the market. Additionally, the introduction of new fixed-dose combination products is expected to drive market growth. Aerie’s Roclatan, another product from the same company, is forecast to achieve high sales among these new drugs[3].

Key Players and Collaborations

Aerie Pharmaceuticals and Santen Pharmaceutical Co., Ltd.

The collaboration between Aerie Pharmaceuticals and Santen Pharmaceutical Co., Ltd. is crucial for the development and commercialization of Rhopressa in Japan and other Asian countries. This partnership ensures that the drug is developed and marketed effectively in these regions, contributing to the overall market growth[1].

Future Projections

Regulatory Submissions and Market Expansion

With the completion of the first Phase 3 clinical trial in Japan, Aerie Pharmaceuticals expects to complete the trial by the end of 2021 and report topline results shortly thereafter. Successful regulatory submissions in Japan and other regions will further expand the market reach of Rhopressa, contributing to its global presence and market share[1].

Long-Term Studies and Pharmacovigilance

Aerie Pharmaceuticals is also conducting long-term studies to evaluate the pharmacovigilance of Rhopressa. These studies aim to monitor the drug's long-term effects on patients with open-angle glaucoma and ocular hypertension, which will provide valuable data for future market growth and patient safety[5].

Key Takeaways

• Clinical Trials: Rhopressa is undergoing Phase 3 clinical trials in Japan to evaluate its efficacy and safety compared to ripasudil.
• Market Growth: The ocular hypertension market is expected to reach USD 4,538.6 million by 2034, driven by novel drug delivery systems and early diagnosis technologies.
• Safety Profile: Rhopressa has shown a manageable safety profile with common adverse events including hyperemia and discomfort with drug administration.
• Collaborations: Aerie Pharmaceuticals and Santen Pharmaceutical Co., Ltd. are collaborating on the development and commercialization of Rhopressa in Japan and other Asian countries.
• Future Projections: Successful regulatory submissions and long-term studies will expand Rhopressa's market reach and contribute to its global presence.

FAQs

Q: What is Rhopressa used for?

Rhopressa, or netarsudil ophthalmic solution, is used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Q: What are the common side effects of Rhopressa?

Common side effects include hyperemia (redness), discomfort with drug administration, and conjunctival hemorrhage, typically mild petechiae at the limbus.

Q: Who is collaborating with Aerie Pharmaceuticals for the development of Rhopressa in Japan?

Aerie Pharmaceuticals is collaborating with Santen Pharmaceutical Co., Ltd. for the development and commercialization of Rhopressa in Japan and other Asian countries.

Q: What is the projected market size for the ocular hypertension market by 2034?

The ocular hypertension market is expected to reach USD 4,538.6 million by 2034, growing at a CAGR of 3.67% from 2024 to 2034.

Q: What are the key drivers of the ocular hypertension market growth?

The market growth is driven by increasing incidences of scarring, inflammation, or structural abnormalities in the eye, novel drug delivery systems, and advancements in diagnostic technologies.

Sources

1. Aerie Pharmaceuticals Completes Enrollment of its first Phase 3 Clinical Trial of Netarsudil Ophthalmic Solution in Japan. Biospace.
2. Ocular Hypertension Market Size to Reach USD 4,538.6 Million by 2034. Biospace.
3. Glaucoma Treatment Market Value Projected to Hit $3 Billion by 2023. Glaucoma Today.
4. Drug Update: Vyzulta and Rhopressa. American Academy of Ophthalmology.
5. Novel Drugs And Devices To Lower Intraocular Pressure Market Size and Trends Report. Coherent Market Insights.