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.

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.