CLINICAL TRIALS PROFILE FOR RHOPRESSA

All Clinical Trials for RHOPRESSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.
NCT05660447 ↗	A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR	Not yet recruiting	Wills Eye	Phase 2/Phase 3	2022-12-19	The purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment repair. Patients eligible for this study are those diagnosed with a rhegmatogenous retinal detachment deemed at high risk for scar tissue formation (a process called 'proliferative vitreoretinopathy').
NCT06033703 ↗	Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment	Not yet recruiting	Massachusetts Eye and Ear Infirmary	Phase 1/Phase 2	2024-02-01	This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes. The second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.

Clinical Trial Conditions for RHOPRESSA

Condition Name

Condition Name for RHOPRESSA
Intervention	Trials
Ocular Hypertension	3
Proliferative Vitreoretinopathy	2
Rhegmatogenous Retinal Detachment	2
Normal Tension Glaucoma	1

Condition MeSH

Condition MeSH for RHOPRESSA
Intervention	Trials
Glaucoma	4
Ocular Hypertension	4
Glaucoma, Open-Angle	3
Retinal Detachment	2

Clinical Trial Locations for RHOPRESSA

Trials by Country

Trials by Country for RHOPRESSA
Location	Trials
United States	37

Trials by US State

Trials by US State for RHOPRESSA
Location	Trials
Georgia	3
Florida	3
California	3
New York	3
Tennessee	3

Clinical Trial Progress for RHOPRESSA

Clinical Trial Phase

Clinical Trial Phase for RHOPRESSA
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	2
Phase 4	2

Clinical Trial Status

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

Clinical Trial Sponsors for RHOPRESSA

Sponsor Name

Sponsor Name for RHOPRESSA
Sponsor	Trials
Price Vision Group	2
Florida Eye Specialists	1
East Coast Institute for Research	1

Sponsor Type

Sponsor Type for RHOPRESSA
Sponsor	Trials
Industry	6
Other	4
UNKNOWN	1

Clinical Trials Update, Market Analysis, and Projection for Rhopressa (Netarsudil)

Last updated: October 28, 2025

Introduction

Rhopressa (netarsudil ophthalmic solution) has gained prominence as a novel therapeutic agent indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Since its FDA approval in December 2017, Rhopressa has marked a significant shift in glaucoma treatment paradigms, primarily owing to its unique mechanism targeting multiple pathways involved in IOP regulation. As the glaucoma drug market continues to evolve with technological advances and increased prevalence, analyzing Rhopressa’s clinical and commercial trajectory is essential for stakeholders.

Clinical Trials Landscape and Updates

Regulatory Approval and Post-Marketing Surveillance

Rhopressa was approved by the U.S. Food and Drug Administration (FDA) under Priority Review based on its ability to reduce IOP via Rho kinase inhibition, a mechanism distinct from traditional prostaglandin analogs and beta-blockers. Post-approval, the focus has shifted toward real-world efficacy, safety, and positioning within combination therapies.

Ongoing and Completed Clinical Trials

Phase 3 Trials and Efficacy Data

The pivotal Phase 3 trials—FYERAL and TRAL—demonstrated that netarsudil resulted in significant IOP reduction (around 22-26%) compared to placebo over 3 months, with a manageable safety profile. Adverse events primarily included conjunctival hyperemia, cornea verticillata, and ocular discomfort, consistent with previous clinical data.

Combination Therapy Trials

Further investigations, including the phase 4 ROCKET trials, are evaluating netarsudil in combination with other glaucoma agents, notably prostaglandin analogs like latanoprost. Results indicate additive IOP reduction, promising a broader therapeutic utility.

Long-Term Safety Studies

Longitudinal studies focusing on safety over 12-24 months are underway, aiming to establish chronic safety and adherence factors. Preliminary data affirm tolerability, with hyperemia rates decreasing over time.

Novel Formulations and Delivery Systems

Research efforts are exploring sustained-release formulations and multi-dose delivery systems to enhance patient compliance and minimize adverse effects. These innovative approaches, if successful, could redefine netarsudil’s clinical positioning.

Market Analysis

Current Market Position

Since its launch, Rhopressa faced competition primarily from fixed-combination therapies, notably Roclatan (netarsudil/latanoprost) and Simbrinza (brimonidine and brinzolamide). While the monotherapy has a niche market, its appeal notably increases in patients intolerant to prostaglandin analogs or requiring multi-mechanistic approaches.

Market Penetration and Adoption Factors

• Physician Positioning: Ophthalmologists appreciate the unique mechanism but remain cautious due to side effect profiles and competition from established drugs.
• Patient Compliance: The once-daily dosing regimen enhances adherence, especially in older populations.
• Cost Factors: Rhopressa’s pricing remains reflective of specialty drugs, with insurance coverage and rebates influencing utilization.

Competitive Landscape

The primary competitors are prostaglandin analogs (e.g., latanoprost, bimatoprost) and combination drugs. The introduction of fixed-dose combinations containing netarsudil has broadened its market access, enhancing its position against standalone agents.

Regulatory and Market Expansion Efforts

The manufacturer is pursuing regulatory approvals in Europe, Japan, and Canada. The European Medicines Agency (EMA) approved Rhopressa in 2020 for OAG and OHT, expanding revenue streams and market scope.

Market Projection and Future Outlook

Forecast Assumptions

• Global Prevalence: The global glaucoma patient population exceeds 80 million, with an annual growth rate of 4%, driven by aging demographics.
• Market Penetration: Conservative estimates project Rhopressa capturing 15-20% of the glaucoma monotherapy market over five years, bolstered by increased awareness and novel formulations.
• Combination Therapies: Rising use of fixed-combinations containing netarsudil will account for approximately 35% of Rhopressa-related sales within three years, based on current uptake trends.

Revenue Projections

Analysts project that Rhopressa's global sales could reach $200-300 million by 2027, driven by increased adoption in key markets and formulation innovations. The North American market will remain dominant, though European expansion could add significant revenue.

Factors Influencing Growth

• Pricing Strategies and Reimbursement Policies
• Regulatory Approvals in Emerging Markets
• Development of Long-Acting Formulations
• Clinical Evidence Supporting Combination Use
• Market Education and Physician Adoption Rates

Risks and Challenges

• Adverse effects limiting broader acceptance
• Price competition from generic alternatives and established therapies
• Delayed regulatory approvals or adverse trial outcomes in new indications

Key Takeaways

• Rhopressa's unique mechanism as a Rho kinase inhibitor offers a differentiated approach in glaucoma therapy, with favorable efficacy and safety profiles shaping its clinical niche.
• Continued clinical trials are reinforcing its safety profile and expanding its utility through combination therapy studies.
• Market penetration remains stable, with significant growth potential in both monotherapy and fixed-combination formulations, especially with impending approvals in international markets.
• Pricing, reimbursement strategies, and innovations in drug delivery will be pivotal in maximizing revenue streams.
• Strategic investments in clinical research and market expansion could position Rhopressa as a leading contender among novel glaucoma treatments.

FAQs

1. What is the primary mechanism of Rhopressa?
   Rhopressa (netarsudil) inhibits Rho kinase (ROCK), leading to improved aqueous humor outflow via the trabecular meshwork and reducing IOP.

2. What are the common side effects associated with Rhopressa?
   Conjunctival hyperemia, conjunctival hemorrhage, cornea verticillata, and ocular discomfort are typical; these are generally mild and decrease over time.

3. How does Rhopressa compare with traditional glaucoma medications?
   Unlike prostaglandin analogs, Rhopressa reduces IOP through trabecular outflow enhancement, offering an alternative for patients intolerant to prostaglandins or needing combination therapy.

4. Are there ongoing studies for Rhopressa in other indications?
   Primarily focused on glaucoma and OHT, ongoing research also examines combination therapies and novel delivery systems to optimize treatment adherence.

5. What is the outlook for Rhopressa’s global market presence?
   With regulatory approvals in Europe and planned expansions into Asia, combined with ongoing clinical development, Rhopressa’s market outlook remains optimistic, potentially capturing a substantial segment of the glaucoma therapeutics market.

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Sources
[1] FDA Drug Label for Rhopressa.
[2] ClinicalTrials.gov entries for netarsudil.
[3] MarketResearch.com, Glaucoma medications global market analysis.
[4] Company press releases and investor reports.
[5] European Medicines Agency approval documents.