Aerie Reports Positive Study Results for Eye Pressure Drug Rhopressa

Aerie Pharmaceuticals, an ophthalmic pharmaceutical company based in Durham, has reported positive clinical results for Rhopressa, its once-daily eye drop approved for the reduction of elevated eye pressure, a cause of glaucoma.

In a test of patients with open-angle glaucoma or ocular hypertension in both eyes, Rhopressa produced a statistically significant increase in trabecular outflow of about 35 percent over baseline, the company said in a news release. Trabecular outflow is the drainage of aqueous humor, a watery fluid between the lens and cornea, to make room for new fluid.

Elevated intraocular pressure (IOP) in open-angle glaucoma is caused by dysfunction in the trabecular outflow pathway, a series of three structures in the eye that regulate the flow of aqueous humor. The most commonly prescribed drugs for treating elevated IOP don’t address that dysfunction.

Evidence shows Rhopressa does what's needed

“This study confirms that in patients with elevated IOP, Rhopressa lowers IOP by increasing trabecular outflow facility,” said Casey C. Kopczynski, Ph.D., Aerie’s chief scientific officer. “We believe this will give physicians additional confidence that Rhopressa targets the tissue responsible for elevated IOP in their patients, and it will help them understand their options for combining this novel trabecular outflow drug with other therapies that lower IOP through different mechanisms.”

The study’s topline results are consistent with the published results of a similar study in healthy volunteers in which Rhopressa was also shown to exert a statistically significant effect on trabecular outflow facility.

A complete analysis of the latest study data will be presented at a future scientific congress, Aerie reported.

Rhopressa was approved for sale by the U.S. Food and Drug Administration in December 2017 and was launched commercially this April. 

Aerie has a drug candidate, Roclatan, in late-stage clinical development for treating intraocular pressure. Roclatan, a once-daily eye drop, is a fixed-dose combination of Rhopressa (nutarsidil) and the widely prescribed prostaglandin analog latanoprost. 

If approved, Roclatan would be the first glaucoma product to lower intraocular pressure through all known mechanisms:  increasing fluid outflow through the trabecular meshwork; increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain; reducing fluid production in the eye; and reducing episcleral venous pressure. 

The FDA accepted Aerie’s New Drug Application for Roclatan earlier this year and set March 14, 2019, as its goal for completing review of the application. 

Aerie is focused on the discovery, development and commercialization of first-in-class therapies for treating patients with open-angle glaucoma, retina diseases and other eye diseases.

Duke spinout hiring at Durham site

The company, a spinout of Duke University, has about 350 employees at its sites in Durham, Irvine, Calif., Bedminster, N.J., and in Ireland, where it has an office in Dublin and a manufacturing plant in Athlone that is scheduled to come online in 2020. The Durham headquarters has about 60 employees and is adding more.

A year ago the company leased an additional 13,385 square feet of lab and office space at the Imperial Center at 4301 Emperor Boulevard in Durham, just outside Research Triangle Park. The added space gave the company a total of 32,586 square feet at the site.

Aerie is continuing to build out the lab space and is working on a cGMP (current good manufacturing practices) production facility that should be online later this year.

The manufacturing facility will use PRINT technology acquired last year from Durham-based Envisia Therapeutics to produce clinical supplies of the company’s drug candidates for retinal conditions such as wet age-related macular degeneration and diabetic macular edema. PRINT, an acronym for particle replication in non-wetting templates, is a proprietary system for creating precisely engineered, sustained-release products based on fully scalable manufacturing processes.

Aerie’s stock shares are traded on the NASDAQ Global Market stock exchange under the symbol AERI.