April 24, 2015
By Alex Keown, BioSpace.com Breaking News Staff
IRVINE, Calif.-- Aerie Pharmaceuticals, Inc. ’s drug Rhopressa, a once-daily dose drug 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.
The company stock following the disappointing announcement about the drug’s clinical trial fail. The stock is currently trading at $14,24 per share, down from Thursday’s close of $35.36 per share.
“We expected Rhopressa to demonstrate better performance based on the results we saw in the previous Phase 2b studies,” Vicente Anido, chief executive officer of Aerie said in a statement.
It wasn’t all bad news for the Phase III trial, though. 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.
Anido said if the company had adjusted its baseline by on millimeter before trials began, the drug would have met its endpoint.
During clinical trials Rhopressa was used to treat patients with IOPs ranged from above 20 to below 27 mmHg.
“We believe Rhopressa shows great promise at IOPs where the majority of patients are represented. Also, we believe the meaningful decrease in the number of patients that experienced efficacy loss at the lower baseline IOPs supports the potential benefit of the Rhopressa on episcleral venous pressure,” Anido said.
The company does currently not have any approved drugs on the market.
Rhopresa is an eye drop that targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma.
Rhopressa will undergo further Phase III trials later this year. With over $179 million on the company balance sheet, Anido said the company is well-financed to continue research on the drug. Pending results from that trial, as well as two other Phase III trials studying safety rates of the drug, Anido said they could take the drug to federal regulators and submit a new drug application for approval sometime in 2016.
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 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.
As Boston Booms, What’s Next for Biotech?
After a week that saw Boston biotechs vastly increasing their rosters and a new IBM health unit installed, BioSpace wants your predictions for what Boston can expect in the next year. Get out your crystal ball and tell us what you think is most likely in the cards for Genetown!
