What Is Netarsudil Ophthalmic?
Netarsudil Ophthalmic is an FDA-approved medication for ocular hypertension and open-angle glaucoma. It is a type of drug known as a Rho kinase inhibitor. This medication works by reducing the pressure inside the eye, which is a primary risk factor for glaucoma and can lead to vision loss. Netarsudil ophthalmic solution is typically administered once daily in the evening.
Beyond its approved uses, Netarsudil Ophthalmic is also being investigated for its potential to treat other eye conditions. These studies explore its effects on corneal health and its role in managing intraocular pressure in various complex eye disorders. The drug has been studied in 31 trials involving 4,940 participants since its first trial in 2014.
Uses and Conditions Under Study
Netarsudil Ophthalmic is primarily studied for conditions related to elevated pressure within the eye, a key factor in glaucoma. These include Ocular Hypertension, which is high eye pressure without optic nerve damage, and various forms of Glaucoma, such as Open Angle Glaucoma, Primary Open Angle Glaucoma, and Normal Tension Glaucoma. Glaucoma is a leading cause of irreversible vision loss worldwide, and reducing intraocular pressure is the only modifiable risk factor to prevent its progression. Netarsudil Ophthalmic is being investigated in 28 trials for these glaucoma-related conditions, often administered to lower intraocular pressure.
The drug is also under investigation for other significant eye conditions. Fuchs' Endothelial Dystrophy, studied in 4 trials, is a condition affecting the cornea's inner layer. Netarsudil is being evaluated for its effect on corneal endothelial cells, particularly after procedures like cataract surgery. Rhegmatogenous Retinal Detachment is studied in 2 trials, exploring the drug's role in managing this serious condition. Additionally, Netarsudil Ophthalmic is being examined in 2 trials involving Cataract patients, often in combination with other treatments or for its impact on corneal healing post-surgery.
Dosing
Netarsudil Ophthalmic is available as an ophthalmic solution, meaning it is applied directly to the eye as drops. The FDA-approved formulation, known by the brand name Rhopressa, is a 0.02% solution. This is typically prescribed for once-daily use, often in the evening, with one drop applied to each affected eye.
In clinical trials, various strengths and combinations of Netarsudil Ophthalmic have been investigated:
- Netarsudil Ophthalmic Solution has been studied at concentrations of 0.01%, 0.02%, and 0.04%.
- A fixed-combination ophthalmic solution containing Netarsudil 0.02% and Latanoprost 0.005% (known by the brand name Rocklatan) has also been extensively studied. This combination is designed to provide additional intraocular pressure lowering.
- While the standard dosing is once daily, some investigational studies have explored a twice daily application of Netarsudil Ophthalmic Solution.
- Specific formulations like AR-17043 and PG043 at various concentrations were also part of clinical research to determine optimal dosing and efficacy.
Patients should always follow their healthcare provider's instructions for the correct dosage and administration of Netarsudil Ophthalmic.
Side Effects
The most common side effect reported by patients taking Netarsudil Ophthalmic in clinical trials was conjunctival hyperemia, or redness of the eye. The rate of this side effect varied across trials, ranging from 38.8% to 65.0% of patients. For example, in one trial involving 160 patients, 38.8% experienced conjunctival hyperemia, compared to 1.8% of patients who received a placebo.
Other common side effects observed in clinical trials, often compared to placebo, include:
- Ocular irritation considered related to study drug use: 23.2% of patients on Netarsudil Ophthalmic experienced this, compared to 0.0% on placebo (from a trial with 95 patients).
- Conjunctival hemorrhage (bleeding in the eye): 3.8% of patients on Netarsudil Ophthalmic, compared to 0.0% on placebo (from a trial with 160 patients).
- Nasopharyngitis (inflammation of the nose and throat): 3.1% of patients on Netarsudil Ophthalmic, compared to 0.0% on placebo (from a trial with 160 patients).
- Conjunctivitis (inflammation of the conjunctiva): 2.5% of patients on Netarsudil Ophthalmic, compared to 0.0%
Currently Recruiting Trials
Netarsudil ophthalmic is currently being investigated in several clinical trials for various eye conditions. These studies aim to further understand its effects, either alone or in combination with other medications, and explore its potential benefits for patients.
One ongoing Phase 4 study, NCT07325240, sponsored by Mayo Clinic, is comparing the 24-hour effect of a fixed combination of netarsudil-latanoprost (known as Rocklatan) against latanoprost alone. This study is recruiting 30 adults, at least 18 years old, who have open angle glaucoma or ocular hypertension, to evaluate intraocular pressure (IOP) reduction.
Another Phase 4 trial, NCT06865144, sponsored by East Coast Institute for Research, is collecting data on how netarsudil (known as Rhopressa) affects IOP in 70 patients with primary open-angle glaucoma or ocular hypertension who have previously undergone an SLT (Selective Laser Trabeculoplasty) procedure in both eyes.
Researchers at University Hospital Dubrava are conducting two studies exploring the effects of Rho-kinase (ROCK) inhibitors. Study NCT06969586 is enrolling 50 patients with Fuchs endothelial corneal dystrophy, cataract, and glaucoma. It seeks to determine if topical ROCK inhibitors can protect endothelial corneal cells after cataract surgery. Similarly, study NCT06960629 is also enrolling 50 patients with glaucoma and pseudophakic bullous keratopathy to learn if topical netarsudil/latanoprost can improve visual function in this population.
Finally, a Phase 1/Phase 2 study, NCT06033703, sponsored by Massachusetts Eye and Ear Infirmary, is investigating topical netarsudil for the prevention of proliferative vitreoretinopathy in patients with retinal detachment. This study plans to enroll 48 participants and aims to understand the drug's pharmacokinetics in the eye's posterior segment and assess its safety in preventing tractional membranes.
Where to Participate
Clinical trials for Netarsudil Ophthalmic are currently recruiting participants across various locations in the United States, providing opportunities for patients in different regions to contribute to research. These studies are conducted at specialized sites to ensure proper care and data collection.
The top recruiting locations for Netarsudil Ophthalmic trials include:
- Jacksonville, Florida
- Boston, Massachusetts
- Rochester, Minnesota
General eligibility criteria for these trials typically include adults between 18 and 90 years of age, with participation open to all genders. Some studies may also recruit healthy volunteers, while children are generally not included in these specific trials.
Development Timeline
The journey of Netarsudil Ophthalmic began with its first clinical trial on February 7, 2014. Since then, the drug has been explored across a broad spectrum of conditions, demonstrating a significant expansion in its therapeutic focus.
Initially, early investigations for Netarsudil included conditions such as IBS-C and hyperphosphatemia. However, the development pipeline quickly shifted and expanded to primarily target various ophthalmic conditions. Key indications that emerged include Glaucoma, Fuchs' Endothelial Dystrophy, Open-angle Glaucoma, and Rhegmatogenous Retinal Detachment, among others. This strategic evolution highlights the drug's potential in eye care.
To date, a total of 31 clinical trials have been conducted or are ongoing, involving approximately 4,940 participants. These trials have progressed through various stages of development, including Early Phase 1, Phase 1, Phase 1/Phase 2, Phase 2, Phase 2/Phase 3, Phase 3, and Phase 4 studies, reflecting a comprehensive evaluation process. Aerie Pharmaceuticals has been a primary driver of this research, sponsoring 12 of these trials.
The latest trial is projected to conclude on May 14, 2026, underscoring the continued commitment to advancing understanding and applications of Netarsudil Ophthalmic.