Glaukos Submits New Drug Application to FDA for iDose TR

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.

Glaukos Submits New Drug Application to FDA for iDose TR
February 28, 2023
Revolutionary Drug Treatment For Cataracts Shows Extremely Positive Lab Results

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.

Revolutionary Drug Treatment For Cataracts Shows Extremely Positive Lab Results
May 18, 2022
BRIM Biotechnology Receives FDA Orphan Drug Designation for BRM424 for Neurotrophic Keratitis

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.

BRIM Biotechnology Receives FDA Orphan Drug Designation for BRM424 for Neurotrophic Keratitis
December 08, 2022
Harrow Health Announces FDA Acceptance of New Drug Application for Ocular Pain Management

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 Announces FDA Acceptance of New Drug Application for Ocular Pain Management
February 23, 2022
Harrow Health Launches Lopidine 1% and Maxitrol in the United States

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 Health Launches Lopidine 1% and Maxitrol in the United States
June 27, 2022
Harrow Announces FDA Approval of Iheezo for Ocular Surface Anesthesia

Harrow and Sintetica SA jointly announced the FDA approval of Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.

Harrow Announces FDA Approval of Iheezo for Ocular Surface Anesthesia
September 28, 2022
FDA Accepts Oxular’s IND Application for the Treatment of Diabetic Macular Edema

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).

FDA Accepts Oxular’s IND Application for the Treatment of Diabetic Macular Edema
January 26, 2023
Outlook Therapeutics Announces FDA Acceptance of BLA for ONS-5010 as a Treatment for Wet AMD

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.

Outlook Therapeutics Announces FDA Acceptance of BLA for ONS-5010 as a Treatment for Wet AMD
October 31, 2022
Amneal Receives FDA Approval for Difluprednate Ophthalmic Emulsion

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.

Amneal Receives FDA Approval for Difluprednate Ophthalmic Emulsion
November 23, 2021
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