We had 13 eye-related FDA approvals in 2018. Here is your quick rundown.
1. Dexycu – It’s a sustained-release one-time injection of dexamethasone in the anterior chamber after cataract surgery. More info here.
2. Systane Complete – This artificial tear gives relief to patients with evaporative dry eye, aqueous deficient dry eye, and/or a combo of both.
3. IDx-DR – An artificial intelligence diagnostic system that analyzes fundus photos to determine if diabetic retinopathy is present. More info here.
4. Artificial Iris Implant – The first prosthetic iris for adults and children with congenital aniridia or other iris defects. More info here.
5. iStent Inject – It’s a Micro-Invasive Glaucoma Surgery (MIGS) device and is the second generation of the iStent which was approved in 2012. More info here.
6. Refresh Repair – An over-the-counter drop that contains osmoprotectants and is focused around the hyperosmotic surface found in dry eye. More info here.
7. Alleye – A mobile app indicated for the screening and monitoring of macular degeneration. More info here.
8. Cequa – A prescription eye drop indicated to increase tear production in patients with dry eye. It’s cyclosporin 0.09%. More info here.
9. Inveltys – It’s loteprednol etabonate ophthalmic suspension 1% and is approved for the treatment of postoperative inflammation and pain following ocular surgery. More info here.
10. Oxervate – It contains cenegermin which is a recombinant form of human nerve growth factor. It’s approved for the treatment of neurotrophic keratitis. More info here.
11. Xelpros – It’s latanoprost 0.005%. Xelpros is the only form of latanoprost that is not formulated with benzalkonium chloride (BAK). More info here.
12. Yutiq – It’s a fluocinolone acetonide intravitreal implant approved for patients with chronic noninfectious posterior uveitis. More info here.
13. Dextenza – It’s a dexamethasone insert, placed through the punctum into the canaliculus and delivers dexamethasone to the ocular surface for up to 30 days. More info here.
