Perspective

FDA approves Aerie’s Rhopressa for glaucoma

Aerie Pharmaceuticals recently announced the FDA approval of Rhopressa, a first-in-class therapy for the treatment of patients with open-angle glaucoma and other diseases of the eye.

Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. The drop was approved by the FDA ahead of the scheduled Prescription Drug User Fee Act date of Feb. 28, 2018, according to a company release.

The therapy is believed to reduce IOP by increasing outflow of aqueous humor through the trabecular meshwork, according to Aerie Pharmaceuticals.

“The approval of once-daily Rhopressa represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians. It is a testament to years of successful research and development and the incredible talents of our dedicated employees, to whom we owe much gratitude. We have been preparing for commercialization for well over a year, and our plans are clear. We will hire our sales force of 100 sales representatives early in the first quarter of 2018, and plan to launch by mid-second quarter of 2018," Vicente Anido, Jr., PhD, chairman and CEO at Aerie, said in a company press release.

 

Aerie Pharmaceuticals recently announced the FDA approval of Rhopressa, a first-in-class therapy for the treatment of patients with open-angle glaucoma and other diseases of the eye.

Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. The drop was approved by the FDA ahead of the scheduled Prescription Drug User Fee Act date of Feb. 28, 2018, according to a company release.

The therapy is believed to reduce IOP by increasing outflow of aqueous humor through the trabecular meshwork, according to Aerie Pharmaceuticals.

“The approval of once-daily Rhopressa represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians. It is a testament to years of successful research and development and the incredible talents of our dedicated employees, to whom we owe much gratitude. We have been preparing for commercialization for well over a year, and our plans are clear. We will hire our sales force of 100 sales representatives early in the first quarter of 2018, and plan to launch by mid-second quarter of 2018," Vicente Anido, Jr., PhD, chairman and CEO at Aerie, said in a company press release.

 

    Perspective
    Michael Chaglasian

    Michael Chaglasian

    Netarsudil is a Rho kinase inhibitor, which is believed to reduce IOP by increasing the outflow of aqueous humor through the trabecular meshwork route. This is a completely new class of glaucoma medication that is directed at the primary mechanism for increased IOP.

    Additional clinical research has suggested that netarsudil may also lower episcleral venous pressure and reduce aqueous humor formation. In multiple, randomized FDA clinical trials among patients with open angle glaucoma and ocular hypertension Rhopressa lowered mean IOP by 5 mm Hg. Rhopressa also did very well in patients with lower IOP, suggesting a role in patients with normal pressure glaucoma (this indication is not in the FDA labeling).

     Rhopressa is dosed once daily and can be prescribed along with all other glaucoma medications. The most common side effect noted in the clinical trials was conjunctival hyperemia (53%), most commonly described as mild. There was no evidence of any systemic side effects. These results were documented through 12 months of follow-up.

     Rhopressa represents an important and exciting new category of treatment options for patients with glaucoma. Its primary role will be as adjunctive therapy to patients who are already on a prostaglandin analogue. Its unique mechanism of action, safety, efficacy and once-per-day dosing place it as a strong contender amongst the other adjunctive options.

    Expected availability of Rhopressa is projected for mid-second quarter in 2018. Soon after that we’ll have enough clinical experience to make more specific recommendations on its role in glaucoma management.

    References:

    Wang SK, et al. Clin Ophthal. 2014;doi:10.2147/OPTH.S41000.

    Wang RF, et al. J Glaucoma. 2015;doi:10.1097/IJG.0b013e3182952213

    Kiel JW, et al. J Ocul Pharmacol Ther. 2015;doi:10.1089/jop.2014.0146.

    • Michael Chaglasian, OD, FAAO
    • President, Optometric Glaucoma Society

    Disclosures: Chaglasian reports he is on an advisory board for Aerie Pharmaceuticals.