Rhopressa Approved to Lower Intraocular Pressure
December 18, 2017 – The U.S. FDA has approved Rhopressa® (netarsudil 0.02%) ophthalmic solution, manufactured by Aerie Pharmaceuticals, to reduce intraocular pressure in patients who have open-angle glaucoma or ocular hypertension. Rhopressa is the first drug in a new class known as rho kinase inhibitors.
Caused by excessive accumulation of aqueous humor (a fluid found inside of the eye), elevated intraocular pressure can lead to lasting damage that may result in vision loss. Rhopressa is thought to work by increasing the amount of aqueous humor that exits the eye through the trabecular meshwork. The trabecular meshwork, an area of tissue found at the base of the cornea, plays a key role in maintaining proper intraocular pressure. Rhopressa may also help to reduce the amount of fluid produced in the eye, and prevent the buildup of fibers in the trabecular meshwork.
Recommended dosing is one drop per day, in the evening, in the affected eye. Patients should take Rhopressa no less than five minutes before or after other topical ophthalmic medications they may be using. Missed doses should be delayed until the next evening, as Rhopressa is not well-tolerated if taken more than once per day. The product will be available in bottles containing 2.5mL of solution.
Rhopressa is the first product made by Aerie to receive FDA approval. A second product, Roclatan™ (netarsudil 0.02%/latanoprost 0.005%) ophthalmic solution, is currently in development. Aerie plans to launch Rhopressa during the second quarter of 2018. Pricing has not yet been announced.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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