The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.
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).
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.
Lensar announced FDA 510(k) clearance for its ALLY Adaptive Cataract Treatment System. ALLY is the first FDA-cleared platform to enable cataract surgeons to complete femtosecond-laser-assisted cataract surgery procedure in a single, sterile environment.
Harrow and Sintetica SA jointly announced the FDA approval of Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.
Kiora Pharmaceuticals has received orphan drug designation from the FDA for its investigational treatment of retinitis pigmentosa, KIO-301. Kiora expects to initiate clinical trials of KIO-301 in Q3 2022.
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.