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
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
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