FDA panel recommends approval of riboflavin, UV for keratoconus, corneal ectasia

Amid concerns about study data and labeling, a joint panel of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel recommended approval of Avedro’s combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking.Photrexa Viscous (riboflavin ophthalmic solution with 20% dextran)/Photrexa (riboflavin ophthalmic solution with 0% dextran) with the KXL system (UVA light) is the first cross-linking treatment to be considered for approval in the U.S.

FDA grants marketing approval for generic Lumigan

Lupin Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration to market a generic version of Allergan’s Lumigan in the U.S.This approval to market bimatoprost ophthalmic solution 0.03% follows a January FDA audit of the company’s Indore, India, facility where the product was made, according to a company press release.

Ziemer LDV Z8 allows high-precision cataract surgery, shorter surgical times

ISTANBUL — A new high-frequency femtosecond laser system for cataract surgery allows high-precision, efficient surgery and a fast, smooth workflow with the patient in one place throughout the procedure.“The combination of low energy and high pulse repetition rate differentiate the Ziemer LDV Z8 from previous systems. The spots overlap, making a real cut, with no tissue bridges,” Bojan Pajic, MD, PhD, said at the winter meeting of the European Society of Cataract and Refractive Surgeons.