The phase II success seen with Aerie Pharmaceuticals’ combination eye drops, Roclatan, raises the possibility that the newly public company could end up with one of the most effective glaucoma products on the market. The company’s share price soared 28% to an all-time high of $26.98, putting the stock up more than 150% since its IPO in October.
The company plans to market the drug itself in North America – launch is expected in 2018 – but rights elsewhere are up for grabs. A partnership for Roclatan is now likely, and with the project outperforming the generic market leader, latanoprost, Aerie will not sell cheaply in the event of a potential takeover.
Roc and roll
Roclatan, previously known by the code PG324, is a fixed-dose combination of Aerie’s glaucoma drug Rhopressa and latanoprost. Rhopressa, coded AR-13324, inhibits rho kinase and norepinephrine transporter – addition of the prostaglandin latanoprost gives the combination three pharmacological actions.
The 28-day, 297-patient phase IIb trial was designed to show Roclatan’s superiority over each of its constituents. Roclatan at a 0.02% dose achieved statistically significant superiority over both latanoprost and Rhopressa on day 8, day 15 and day 29 – day 29 was the relevant timeframe for the primary endpoint.
Roclatan lowered mean diurnal intraocular pressure (IOP) on day 29 from a baseline of 25.1mmHg to 16.5mmHg, a 34% decrease in IOP. The average reduction in IOP on day 29 achieved with Roclatan was 1.9mmHg greater than with latanoprost and 2.6mmHg more than Rhopressa.
Additionally, half the Roclatan patients had a 35% decrease from baseline in mean diurnal IPO – nearly twice the number of patients that achieved this with latanoprost. Speaking on a conference call, Aerie’s chief executive, Vicente Anido, called this “a big deal”, saying that glaucoma patients focued on trying to get this 35% decrease in IOP. “The FDA has never seen a drug that drops pressure this far,” he added.
A 0.01% dose of Roclatan was also tested, but did not show the same degree of efficacy. Fortunately for Aerie, the higher dose did not prompt safety concerns, with the worst adverse event being “purely cosmetic” eye redness, reported in 40% of patients. For comparison, Mr Anido said 45% of patients treated with Allergan’s Lumigan and 50% of those on Novartis’ Travatan had eye redness. However, no more than 15% of latanoprost patients experienced red eyes, according to the drug’s label.
The company will push forward with a phase III trial of the combination next summer, and this will have the same design but last for 90 days. It says this is a standard length for a phase III study of a glaucoma project.
As might be expected, Rhopressa alone is less powerful than the combination, but this means it has a niche of its own. Aerie intends to market Rhopressa to patients with mild glaucoma: those with IOP of less than 26mmHg. Roclatan will be targeted at patients with more severe cases.
Mr Anido believes that Roclatan can match the achievements of latanoprost, which as Pfizer’s Xalatan sold $1.7bn at its peak in 2010, as it is “an even better drug”.
Despite these hefty sales expectations, the company is only interested in a licensing deal outside North America. “We can certainly address the US and Canadian markets with our own sales force,” Mr Anido said.
Consensus forecasts for Roclatan’s 2020 worldwide sales are $127m, according to EvaluatePharma. But RBC analysts now pencil in peak global Roclatan revenue of $1.8bn.
|Phase IIb trial of Roclatan in 297 glaucoma patients||NCT02057575|