Aerie's eye drops win FDA approval
- Aerie Pharmaceuticals has received Food and Drug Administration approval for eye drops that reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The biotech will market its new medicine under the branded name Rocklatan.
- The medicine is a combination of latanoprost, a widely used therapy, and netarsudil, the active ingredient in another treatment for intraocular pressure called Rhopressa that Aerie launched last year.
- Aerie expects Rocklatan to enter the U.S. market in the second quarter. The company confirmed to BioPharma Dive the drug would be priced at a small premium to Rhopressa, costing between $110 to $115 per bottle on a net basis.
Expectations are high for Rocklatan, which proved more effective than the widely prescribed latanoprost in a Phase 3 study in 2017. The drug is the "crown jewel" in Aerie's pipeline, Raymond James analyst Elliot Wilbur said in a note to investors.
The company plans to capitalize on the marketing structure it built for Rhopressa last year to quickly build sales for the new once-daily eye drop.
"Our existing salesforce, which has been calling on U.S. eye-care professionals since last May, is very well positioned to introduce Rocklatan to these doctors and help them understand the clinical utility of both products in the care of their patients with glaucoma," Aerie CEO Vicente Anido Jr. said in a March 12 statement announcing the approval.
Aerie is also working to secure reimbursements for the new therapy, with major payers already taking up reviews, Anido said. Rhopressa is "now enjoying broad commercial and Medicare Part D coverage," he said.
Rocklatan will likely cost 10% to 15% more than Rhopressa, according to Raymond James' Wilbur. The investment bank estimates peak sales of the drug will reach $647 million in 2025, less than a consensus of $735 million. An Aerie spokesperson didn’t immediately respond to a request for comment on the price of the drug.
Rocklatan will enter a glaucoma market worth about $3 billion, according to slides Aerie prepared for investors. Last year, latanoprost had about 41% of the market share, according to the presentation.
Aerie said it expects net revenue of $110 million to $120 million this year across the whole company. It didn’t break down the guidance into sales for each portfolio product.
- BioPharma Dive Aerie eyes glaucoma market after early FDA win