November approvals lead FDA activity in ophthalmology
The FDA’s ophthalmology-related news in November included device, drug and feasibility study approvals.
Here are the four most-read FDA news stories published on Healio.com/OSN last month:
1. FDA approves Light Adjustable Lens from RxSight
The Light Adjustable Lens with the Light Delivery Device from RxSight is the first medical device system that can make adjustments to lens power after cataract surgery. Read more here.
2. FDA gives nod to Bausch + Lomb’s once-daily glaucoma drops
Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. It is the first prostaglandin analog to have nitric oxide as one of its metabolites. Read more here.
3. FDA approves study of Orion cortical visual prosthesis system
The Orion device from Second Sight Medical Products converts images captured by a miniature video camera mounted on a patient’s glasses into a series of small electrical pulses, transmitting those pulses to an array of electrodes implanted on the surface of the visual cortex. Read more here.
4. Ivantis sends premarket approval submission for Hydrus microstent to FDA
Ivantis has submitted a final premarket approval module to the FDA for its Hydrus microstent to lower IOP in open-angle glaucoma. Read more here.