Glaukos announced the submission of a new drug application (NDA) to the FDA for iDose TR. iDose TR is a micro-invasive intraocular implant that has been created to continuously provide therapeutic levels of a proprietary formulation of travoprost.
A revolutionary new treatment for cataracts has shown extremely positive results in laboratory tests, giving hope that the condition, which currently can only be cured with surgery, could soon be treated with drugs.
BRIM Biotechnology announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for BRM424 for the treatment of neurotrophic keratitis (NK), a rare degenerative eye condition that can cause blindness.
The FDA has accepted Harrow Health's new drug application (NDA) for AMP-100, the company's drug candidate for ocular surface anesthesia and intraoperative pain management during ocular surgery.
Harrow Health announced the completion of the transfer to Harrow of the new drug applications (NDAs) of recently acquired, FDA-approved ophthalmic medicines, Iopidine 1%, Maxitrol 3.5mg/10,000 units/0.1%, and Moxeza 0.5%.
Harrow and Sintetica SA jointly announced the FDA approval of Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.
The U.S. Food and Drug Administration has approved Oxular Limited's investigational new drug application (IND) for suprachoroidal OXU-001 for the treatment of diabetic macular edema (DME).
Outlook Therapeutics announced that the FDA accepted for filing a Biologics License Application for ONS-5010/Lytenava (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.
Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol.