Keyword: Ocular Therapeutix
After twice being sidelined by manufacturing-related CRLs, Ocular Therapeutix got FDA approval on Monday for its first eye drug.
Manufacturing has for the second time stepped on Ocular Therapeutix’s chance of an FDA approval for its new drug for pain following eye surgery.
In a recent blog post, Dr. John Hovanesian of California said that sustained drug delivery systems targeting eye disease would be far more beneficial for not only compliance but for the ocular surface versus traditional eye drops.
Just days after Valeant Pharmaceuticals' plans for a new eye drug were upended by a complete response letter (CRL) tied to its manufacturing operations, Ocular Therapeutix got one as well. It's the fourth time this year that a drug approval has been sidelined because the FDA was not satisfied with the manufacturing facility in which the drug was to be produced.