Manufacturing issues threaten delay for Aerie eye drug
- Aerie Pharmaceuticals Inc. said Tuesday it did not expect ongoing compliance issues at a third-party manufacturer to derail an approval decision on its glaucoma drug Rhopressa next February.
- "We currently believe it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa," Aerie reported in a statement.
- The third party manufacturer is currently working to resolve Good Manufacturing Practice (GMP) issues raised by the Food and Drug Administration in an inspection of its Tampa, Florida, facility.
Rhopressa has already been delayed once: Aerie pulled its New Drug Application to the FDA last October after the manufacturer informed Aerie that its Tampa facility would not be ready for a pre-approval inspection.
Rhopressa (netarsudil ophthalmic solution, 0.02%) would be Aerie's first commercial product if successfully approved by the FDA. It would compete with Valeant Pharmaceuticals International Inc.'s experimental Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), if both secure approval. The drugs lower intraocular pressure (IOP) for patients with glaucoma.
Aerie also has another candidate currently in late-stage testing that could have an edge over both, combining Rhopressa's active ingredient with the commonly used prostaglandin analog latanoprost. If all goes well, Aerie plans to submit Roclatan for U.S. approval in the first half of 2018, targeting a potential launch a year after that.
- Aerie Pharmaceuticals, Inc. Press release
- BioPharma Dive Background: Aerie shares rise on trial success for eye drug
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