- California-based Aerie Pharmaceuticals Inc. has joined the ranks of commercial-stage biotechs, announcing Monday the early approval of its eye drug Rhopressa by the Food and Drug Administration.
- Rhopressa is designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and comes with lofty peak sales forecasts as a new agent in a growing glaucoma market.
- The FDA OK'd Rhopressa with a relatively clean label, notes Cowen & Co analyst Ken Cacciatore, de-emphasizing a safety issue that had previously attracted attention.
Aerie plans to ramp up its commercial efforts quickly, noting that it will finish hiring a 100-representative strong sales force early in the first quarter of next year ahead of a planned second-quarter launch.
"We have been preparing for commercialization for well over a year, and our plans are clear," said Aerie CEO in a a Dec.18 statement.
The company hopes to secure formulary coverage for commercial plans in 2018, although it doesn't expect to achieve formulary coverage for patients on Medicare Part D until the beginning of 2019.
Manufacturing issues had previously derailed a regulatory decision on Rhopressa (netarsudil ophthalmic solution) in October of 2016, when Aerie pulled its New Drug Application after the FDA raised concerns about a manufacturing plant the company had contracted to produce the drug. The facility's owner, Valeant Pharmaceuticals International Inc., was eventually able to reach an understanding with the FDA on the GMP issues that allowed for regulatory submissions to progress.
Interestingly, Rhopressa will likely face competition from a recently approved drug made by Valeant in the same facility the Canadian pharma produces Rhopressa for Aerie. Vyzulta (latanoprostene bunod ophthalmic solution) was approved in November to reduce eye pressure in the same patient population as Rhopressa. Distribution of Vyzulta to pharmacies in the U.S began on Monday.
In clinical studies, Rhopressa showed similar benefit to the generic drug timolol in patients with lower baseline levels of intraocular pressure. For patients with higher baseline levels, however, timolol retained an edge — albeit with a more frequent dosing regimen. Rhopressa also led to eye redness in more than half of clinical trial participants, and to corneal deposits in roughly a fifth, leading to some discontinuation of treatment.
Still, Cowen's Cacciatore believes Rhopressa could quickly become a preferred option for adjunct treatment of glaucoma, citing the drug's novel mechanism of action and more convenient dosing.
Yet it's unclear if payers will be convinced by the drug's efficacy profile compared to cheaper, generic options like timolol.
"The company has previously publicly stated that it expects a list price of at least $100 per month net of rebates and other fees and discounts. There is a month’s worth of eye drops in a bottle. The company is not providing additional information at this time," said Aerie about price in a statement to BioPharma Dive.
Aerie also has another experimental drug, Roclatan (netarsudil/latanoprost opthalmic solution), that combines Rhopressa's active ingredient with the commonly used latanoprost. Studies of Roclatan showed superior intraocular pressure lowering to both Rhopressa and latanoprost.
"Our consultants have been consistent that Rhopressa appears to be a superior adjunct glaucoma agent, while Roclatan appears to be the most effective first-line IOP-lowering agent ever developed," Cacciatore wrote in a Dec. 19 note to investors.
With one approval in hand and another agent nearing regulatory filing, Aerie could become an attractive takeout option for ophthalmology-focused biopharmas.