FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices

The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.

FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices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
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
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
Lensar Receives FDA Clearance of ALLY Adaptive Cataract Treatment System

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.

Lensar Receives FDA Clearance of ALLY Adaptive Cataract Treatment System
June 14, 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
Kiora Pharmaceuticals Granted Orphan Drug Designation for KIO-301, an Investigational Drug for the Treatment of Retinitis Pigmentosa

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.

Kiora Pharmaceuticals Granted Orphan Drug Designation for KIO-301, an Investigational Drug for the Treatment of Retinitis Pigmentosa
March 21, 2022
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
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