September 17, 2015
By Alex Keown, BioSpace.com Breaking News Staff
IRVINE, Calif. — The second time may be the charm for Aerie Pharmaceuticals, Inc. ’s glaucoma drug Rhopressa. This morning the company reported its second Phase III trial showed the triple-action eye drop lowered intraocular pressure in patients with glaucoma and ocular hypertension.
Company stock soared in aftermarket trading Wednesday when news about the trial’s success began to leak. Shares rose about 70 percent to $30.59 per share in aftermarket trading. The stock is currently trading at $30.36 per share.
In its latest trial, dubbed Rocket 2, Rhopressa given at doses of both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg over a 90 day period. The most common Rhopressa adverse event was hyperemia, or eye redness, which was reported as increased in 35 percent of patients.
Primary endpoints for Rocket 2 were moved after an earlier trial failed to meet its endpoints. In April, Aerie revealed Rhopressa, aimed at lowering intraocular pressure above 26mmHG in glaucoma patients, failed to meets its goal of proving more effective than the twice-daily timolol, the most widely used comparator in registration trials for glaucoma. Rhopressa did have success in patients with IOP below 26 millimeters of mercury (mmHg) at all nine measured time points and numerical superiority over timolol at the majority of measured time points. Approximately 80 percent of glaucoma patients have IOP of 26mmHg or less at the time of diagnosis.
“This product has demonstrated great promise with its novel mechanisms of action, including its ability to target the diseased tissue responsible for elevated IOP in glaucoma. The clear success demonstrated in this clinical trial, combined with the preclinical research to date on the disease-modification potential of Rhopressa, represent key building blocks in driving Aerie toward becoming a major ophthalmic pharmaceutical company,” Vicente Anido, chairman and chief executive officer at Aerie, said in a statement.
Glaucoma can cause blindness if it is left untreated. Glaucoma is not curable, and vision lost cannot be regained. However, some medications my halt disease progression.
Rocket 3 is a 12-month safety study currently being conducted in Canada. Rocket 4 is expected to being later this month. Following the trial’s success, Aerie said it will seek regulatory approval in mid-2016.
Preclinical results have demonstrated that Rhopressa also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects, the company said.
Richard Lewis, Aerie’s new chief medical officer and a glaucoma specialist, said physicians and clinicians have been waiting for an IOP-lowering product that targets the diseased tissue in the eye.
“None of the treatments currently in the market have this unique function. The Rhopressa efficacy data we see in these Rocket 2 results point to a potential breakthrough for our glaucoma patients,” Lewis said in a statement.
In addition to Rhopressa, Aerie also has another drug in clinical trials. The second drug, Roclatan, combines Rhopressa with another drug called latanoprost. Latanoprost is manufactured by Pfizer Inc. under the brand name Xalatan. The combination drug is intended to reduce eye pressure in patients with glaucoma. The company is planning to start late-stage trials of Roclatan in the middle of the year, the Associated Press reported.
Aerie is a spinout of Duke University. The original research began at Proctor & Gamble under Mitch DeLong. In 2006, after the research seemed to hit a dead end, the research was gifted to Duke. The company went public in October 2013 and raised about $60 million.
