Investigation to initiate in Q2 2023
CAMBRIDGE, MA, January 31, 2023 /24-7PressRelease/ -- Glint Pharmaceuticals (Glint), a clinical-stage biotechnology company focused on developing a next-generation contact lens drug delivery technology, announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its antibiotic drug delivery contact lens, ACL5. Glint anticipates beginning the investigation in Q2 2023.
Glint plans to perform a Phase 1 Phase 2 clinical trial to evaluate ACL5 (lens is soaked in 5 mg/ml drug solution) as a single agent for the treatment of patients with corneal infection. ACL5 includes moxifloxacin, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by various susceptible strains of various bacterial organisms. Moxifloxacin will be released over several days to treat bacterial infection and corneal damage. The study will establish safety, tolerability, pharmacokinetics, and infection-fighting properties in patients wearing the drug-eluting contact lenses for a predetermined period of time.
"We believe that ACL5 has the potential to improve clinical responses to corneal infection and damage in up to 5 million people in the US and Europe, without the use of daily eye drops," said Chris Adams, CEO of Glint. "We look forward to collaborating with our clinical partners to launch this trial in the United States in early 2023 and to announce initial results in late 2023."
Glint Pharmaceuticals is developing a patented drug delivery system for the treatment and prevention of ocular infections and disorders. Eye infections and corneal abrasions, glaucoma, post-surgical ocular inflammation, allergic conjunctivitis, and dry eye are examples of disorders to be addressed. More than 40 million Americans are estimated to have ocular surface disease. The patent-protected Glint technology has the potential to enhance therapeutic efficacy and increase patient compliance. Glint has licensed the contact lens technology from the University of Florida.
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