FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices

The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.

FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices
August 02, 2022
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
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
Pharmedica USA Recalls Purely Soothing 15% MSM Drops Due to Non-Sterility

Pharmedica USA has issued a worldwide recall for two lots of Purely Soothing, 15% MSM Drops, at the consumer level due to non-sterility concerns. The use of contaminated eye drops can pose a risk of eye infections and vision loss.

Pharmedica USA Recalls Purely Soothing 15% MSM Drops Due to Non-Sterility
March 08, 2023
Rayner Recalls RayOne Preloaded Hydrophilic IOLs Due to Package Mislabelling

According to a notice published by the FDA on July 6, Rayner has issued a letter to recall its RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens.

Rayner Recalls RayOne Preloaded Hydrophilic IOLs Due to Package Mislabelling
August 12, 2022
Amydis Completes Pre-IND Meeting with FDA for Development of First-in-Class Retinal Tracer for Diagnosis of ALS

Amydis announced the successful completion of a pre-IND (investigational new drug) meeting with the FDA regarding the development plans for a small-molecule tracer to detect TDP43 in the retina of amyotrophic lateral sclerosis (ALS) patients.

Amydis Completes Pre-IND Meeting with FDA for Development of First-in-Class Retinal Tracer for Diagnosis of ALS
December 07, 2021
FCI Ophthalmics Announces FDA Clearance of Oculid Implantable and External Eyelid Weights for the Treatment of Lagophthalmos

FCI Ophthalmics announced that the FDA has cleared Oculid implantable and external lid weights indicated for the surgical and non-surgical treatment of lagophthalmos, respectively.

FCI Ophthalmics Announces FDA Clearance of Oculid Implantable and External Eyelid Weights for the Treatment of Lagophthalmos
February 15, 2022
AffaMed Announces IND Clearance by the FDA for AM712 for the Treatment of Retinal Vascular Diseases

AffaMed Therapeutics announced that the FDA has approved its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712).

AffaMed Announces IND Clearance by the FDA for AM712 for the Treatment of Retinal Vascular Diseases
February 16, 2022
FDA Clears Cognition Therapeutics’ IND Application for Geographic Atrophy

Cognition Therapeutics announced that its Investigational New Drug (IND) application has been cleared by the FDA for the investigation of CT1812 in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).

FDA Clears Cognition Therapeutics’ IND Application for Geographic Atrophy
March 16, 2023
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
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