Pharmaceutical company Nevakar LLC stated on Tuesday that it has started treatment of its first subject under its Phase 3 clinical trial of NVK-002 for the treatment of myopia (nearsightedness) in children aged 3 to 17 years.
The company said NVK-002 is its investigational, topical ophthalmic solution that is intended to slow the progression of myopia in children.
Following a successful Phase 3 and the US Food and Drug Administration (FDA) approval, NVK-002 would represent the first pharmacologic eye drop for this patient population, according to the company.
Concurrently, the company's Phase 3 trial will enroll 500 subjects aged three to 17 years with myopia Spherical Equivalent Refraction (SER) of at least -0.50 D and no greater than -6.00 D in each eye. It will be conducted in two stages. Stage one will evaluate the safety and efficacy of two concentrations (low dose and high dose) of NVK-002 as compared to placebo for slowing the progression of myopia over a three-year period. Stage two will be a randomized cross-over phase of one year in duration.
In conjunction, NVK-002 will be evaluated against the primary endpoint of a statistically significant overall between-group difference from baseline in the proportion of subjects who show
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT