• Outlook Therapeutics, a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced it re-submitted its biologics license application to the FDA for ONS-5010, an investigational ophthalmic therapy. If approved, it will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD. If ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application for approval to provide the product in a pre-filled syringe that is free from liquid silicone oils and that meets the FDA’s specifications for ophthalmic use. 

• Vyluma Inc., a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced that the last patient visit has been completed for the primary analysis of the pivotal Phase 3 CHAMP (Childhood Atropine for Myopia Progression) clinical study. The CHAMP study has been designed, in collaboration with the FDA, to evaluate whether NVK002, a proprietary, investigational, preservative-free eyedrop administered nightly, is safe and effective as a treatment for the progression of myopia in children. If approved, NVK002 would be the first pharmaceutical treatment for myopia progression in children.

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