Shares of Aerie Pharmaceuticals $AERI skyrocketed on promising data for a combination glaucoma drug that bested its own late-stage drug Rhopressa by adding a well known and widely prescribed generic treatment that significantly improves its effect.
Aerie has filed for an FDA OK on Rhopressa, but investors were quick to turn their attention this afternoon to Roclatan, which adds the generic latanoprost to the mix. The combo drug hit the primary endpoint, according to Aerie, lowering intraocular pressure significantly better than either latanoprost or Rhopressa alone.
Aerie’s shares rocketed up on the news, climbing 65% in premarket trading on the top line results. The biotech wasn’t about to let that opportunity slip by, and this morning outlined plans to sell up to $50 million in shares.
Investigators say that Roclatan’s mean diurnal IOP-lowering “exceeded that of latanoprost by an average across the study duration of 1.9 mmHg and exceeded Rhopressa by 2.6 mmHg.” The combo “reduced mean diurnal IOPs to 16 mmHg or lower in 61 percent of patients, a significantly higher percentage than observed in the comparator arms.”
The combo, though, was also linked with a high rate of eye redness among patients, a trait also tied to Rhopressa. About half of the patients suffered from hyperemia, linked to a high number of dropouts in its studies. This new combo will also have to significantly outperform the generic if it expects to win over US payers.
It hasn’t all been smooth sailing for Aerie in recent years. The biotech had to get the FDA’s permission to change the endpoint for its second late-stage study of Rhopressa in order to avoid back-to-back failures. Now analysts for Raymond James say that they expect the agency will allow Aerie to launch that drug in early 2018 while Roclatan may arrive a year later.
Aerie CEO Vicente Anido, who’s already touted Rhopressa as a likely blockbuster able to earn more than $1 billion a year, had this to say:
“We also noted that the Rhopressa arm demonstrated high levels of efficacy across the full range of baseline IOPs studied, and the efficacy was maintained for the 90-day period. Importantly, Rhopressa demonstrated comparable levels of IOP lowering to latanoprost at baseline IOPs ranging from 20 to 25 mmHg in Mercury 1. This performance for Rhopressa is consistent with levels observed in the previous Phase 2b trials for Rhopressa and Roclatan.”
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