EyeGate surges on FDA nod to start pivotal study; Aldevron to build gene therapy manufacturing campus in Fargus, N.D.
→ EyeGate — a pharmaceutical company specializing in developing treatments for diseases and disorders of the eye — announced the FDA’s approval to initiate its photorefractive keratectomy (PRK) pivotal study. The FDA has asked for modifications to be made to the patient informed consent document prior to patient enrollment in the study and the company says that it will address these modifications immediately and expects enrollment to begin next month.
“We expect to receive topline results by year-end 2019 and, assuming these are positive, plan to submit the de novo application for commercialization shortly thereafter,” said Stephen From, CEO of EyeGate. “Our OGB platform, if approved, will be the first prescription Hyaluronic Acid (“HA”) eyedrop formulation in the U.S. market providing a huge opportunity for us.”
→ Aldevron, specializing in the production of plasmid DNA, proteins, mRNA and antibodies for its clients, announced its plans for expansion with a 14-acre campus at its headquarters in Fargo, ND. The company says that “phase one construction will begin in August,” and that “upon completion of the campus, the annual capacity will exceed $1 billion pf plasmid DNA, RNA, gene editing enzymes and other biologics.”
This expansion plan includes three new buildings that will be built over the next three to five years and have the potential to employ 1,000 people. The first 189,000 square-foot two-story building is expected to be fully operational by Q1 of 2021.