Aerie Looks for Rhopressa NDA in Q3

Aerie Pharmaceuticals has completed all patient visits in two Phase III clinical trials of the Rho kinase inhibitor Rhopressa (netarsudil) 0.02% for treatment of glaucoma and expects to file a New Drug Application with the FDA in the third quarter of this year, president and COO Tom Mitro reported at OIS@ASCRS 2016.

Rhopressa lowers intraocular pressure (IOP) through three mechanisms of action: it inhibits Rho kinase, or ROCK, which improves outflow through the trabecular meshwork; it also inhibits norepinephrine transporter, or NET, which reduces production of aqueous humor; and it lowers episcleral venous pressure.

Mitro summarized the results of the trials accordingly: “Rhopressa dosed once a day was shown to be non-inferior to timolol dosed twice a day in subjects with baseline IOP less than 25 mmHg.” He noted that neither the alpha-agonists nor the carbonic anhydrase inhibitors, which together account for about 20% of the US glaucoma prescription market, were able to achieve non-inferiority to timolol in their Phase III trials. Rhopressa has also demonstrated consistent IOP control over 12 months with no signs of tachyphylaxis.

Meanwhile, Aerie is moving ahead with two Phase III trials for Roclatan, a combination of netarsudil 0.02% and latanoprost 0.005% for glaucoma. Mitro said the company expects top-line results from the first trial in the third quarter of this year.

He noted that preclinical studies have shown netarsudil blocks TGF-beta induced expression of profibrotic markers in cultured human trabecular meshwork cells. TGF-beta is overexpressed in glaucoma patients and is thought to produce fibrosis that constricts the trabecular meshwork, thus reducing fluid outflow and contributing to increased intraocular pressure. Ex vivo studies in human eyes have shown netarsudil can relax the trabecular meshwork and increase its perfusion, which has the potential to preserve the health of this tissue in patients due to enhanced delivery of nutrients and antioxidants, Mitro said.

Mitro also provided an update on Aerie’s potential multi-kinase inhibitor for age-related macular degeneration (AMD), AR-13154. Preclinical studies showed a statistically significant effect in reducing

lesion size in a rat model of laser-induced choroidal neovascularization (CNV).

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