iVeena Announces Successful Completion of Pre-IND Meeting with FDA
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Wednesday, November 10, 2021
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Optical, Science, Other Science, Cornea, Population, Safety, Quality of life, Copper, Maculopathy, Disease, Myopia, LOX, Food, Keratoconus, Retinal detachment, Sclera, Cataract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Achievement Medal, Incidence, Investigational New Drug, Vaccine, Risk, FDA, Child, Orphan, Pharmaceutical industry, IVMED-85, Pediatric Myopia, iVeena, IVMED-85, PEDIATRIC MYOPIA, IVEENA
iVeena Delivery Systems (iVeena) , a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, announces successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for a novel pharmacologic treatment of pediatric myopia.
Key Points:
- iVeena Delivery Systems (iVeena) , a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, announces successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for a novel pharmacologic treatment of pediatric myopia.
- In line with this novel approach the FDA confirmed a 505(b)(1) regulatory submission is appropriate, a drug development pathway for products with no prior regulatory approvals.
- We appreciate the guidance from the FDA as we move into the toxicology program and prepare for the clinic in 2022, said iVeena CEO Jerry Simmons.
- The companys lead programs comprise novel proprietary eye drops; IVMED-80, granted Orphan Drug Designation, for keratoconus and IVMED-85 for myopia.