RHOPRESSA,FDA Approval History,Netarsudyl ophthalmic solution

RHOPRESSA

(Netarsudil)

• General Information About Rhopressa :

Rhopressa (netarsudyl ophthalmic solution) is an inhibitor of Rho kinase.

Rhopressa is primarily recommended in patients with open-angle glaucoma or ocular hypertension for reducing elevated intraocular pressure ( IOP). 

Rhopressa is given as an ophthalmic prescribing remedy. The prescribed dose is once everyday in the evening, one reduction in the affected eye(s). When one dosage is missing, the following dosage in the evening will be followed with care. Dosage is not generally handled twice a day, so is not approved. When Rhopressa is to be used simultaneously with other topical ophthalmic drug products to mitigate IOP, each drug product will be given at least 5 minutes apart.

• FDA approved:     (Approved for first time on 18 December 2017)

• Name of Brand:    Rhopressa

• General name:      Netarsudil

• Form of dosage:   Ophthalmic solution

• Treatment of:        Glaucoma

• Manufactured by: Aérie Pharmaceuticals, Inc. 

• Clinical Research:

FDA Approval

The FDA clearance for Rhopressa was focused on three phase 3 trials, I,II & III Trails. 

Trail I : The study did not reach its primary effectiveness goal by showing non-inferiority of Rhopressa once-daily lowering of IOP relative to twice-daily timolol. Rhopressa showed non-inferiority relative to timolol in patients under 26 millimeters of mercury (mmHg) in the IOP trial at all nine time points measured and numerical dominance over timolol at the plurality of time points measured. 

Trail II :. Rhopressa dosed once daily as well as twice days, reaching its primary effectiveness endpoint indicating non-inferiority along with timolol twice daily. The primary effectiveness outcome tested subjects with baseline IOPs over 20 to below 25 mmHg (millimeters of mercury) in pre-study. Evidence shows a steady lowering of the IOP level over all baseline IOPs and across the 90-day efficacy span. The most frequent adverse effect was hyperemia, which was confirmed to have risen in 35 percent of patients, and was scored as moderate in the Rhopressa once daily arm of the study for 83 percent of patients. 

Trail III : The study reached its primary effectiveness goal showing one-day Rhopressa non-inferiority when opposed to timolol twice daily. Rhopressa also demonstrated non-inferiority relative to timolol at the pre-specified secondary endpoint level from above 20 mmHg to below 27 mmHg, and even below 28 mmHg at a maximum of over 20 mmHg. The efficacy findings showed a significant lowering of IOP over all baseline IOPs in the study, and across the 90-day efficacy duration. 

• Rhopressa Side Effects:

Adverse effects consistent with using Rhopressa can involve the following but are not limited to: 

• corneal verticillata
• conjunctival hemorrhage
• conjunctival hyperemia
• instillation site pain

• Mechanism of Action:

Netarsudil ophthalmic solution is an inhibitor of Rho kinase, which is assumed to suppress IOP by increasing the outflow of aqueous humor by trabecular meshwork. The precise reason behind this is unclear. 

• Instruction :
• Use one drop of the affected eye(s) once daily in the evening.
• If a dosage is missing, the next dosage will be started throughout the evening.
• To prevent contamination of the solution, avoid enabling the tip of the dropper to touch the skin, external surfaces, fingertips, or some other object. Serious eye injury and resulting vision impairment can result from the use of polluted solutions. 
• Rhopressa produces benzalkonium chloride and can be consumed through flexible contact lenses. Contact lenses may be withdrawn prior to instillation of Rhopressa and can be reinserted 15 minutes after administration of Rhopressa.
• If more than one topical ophthalmic drug is used, it should be administered for at least 5 minutes between applications. 

The most frequent side effect is redness in the eyes. Very popular side effects include corneal verticillata, instillation discomfort, and conjunctival bleeding. 

• Cost Of Rhopressa : 

The Price & Cost of Rhopressa ophthalmic solution 0.02% is around $294 for a supply of 2.5 milliliters.