The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.
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.
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.
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.
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.
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.
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.
AffaMed Therapeutics announced that the FDA has approved its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712).
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).
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.