Eye drop developer Oculis showcases positive PhII data; Aquestive hunts for another FDA OK
→ Ophthalmology-focused Swiss drug developer Oculis has rolled out positive data from their Phase II study of OCS-01 — an eye drop formulation of dexamethasone for the treatment of diabetic macular edema (DME). The study met its pre-defined efficacy endpoints and showed that OCS-01 eye drops were more effective than the vehicle in diminishing central macular thickness and improving acuity in patients with DME.
→ After receiving the green light from the FDA to market Exservan, oral film version of a generic ALS drug last November, Aquestive Therapeutics announced that the FDA has accepted the company’s NDA for Libervant (diazepam) buccal film for the management of seizure clusters. A PDUFA date has been set for September 27, 2020.
→ Respiratory disease-focused Enterprise Therapeutics has tapped David Morris as CMO. In his new role, Morris will lead the clinical development for ETD002 and ETD001 — therapies aimed at treating cystic fibrosis patients. Morris joins the company from Novartis Venture Fund, where he currently serves as a managing director and will continue as operating partner. Prior to that, Morris worked with Novartis and Roche.
→ After winning a label extension from the FDA for their blockbuster Ozempic, Novo Nordisk is dropping DKK 800 million in upgrading and expanding facilities at the company’s production site in Kalundborg, Denmark. The injection of cash will boost its capacity to produce diabetes treatments — and the expansion is expected to be completed by 2022.