Ophthalmology’s armamentarium in the United States grew in 2019 with FDA approvals in retina and glaucoma treatment, as well as an approval for the first trifocal IOL.
Here are the top five FDA approvals of the year:
FDA approves Alcon’s AcrySof IQ PanOptix trifocal IOL
PanOptix, which is already available in more than 70 countries, has been shown to deliver a combination of near, intermediate and distance vision while significantly reducing the need for glasses after surgery. Read more.
FDA approves Rocklatan for open-angle glaucoma, ocular hypertension
A fixed-dose combination of netarsudil and latanoprost, Rocklatan — previously known as Roclatan — is designed to target the trabecular meshwork, which is considered the main cause of elevated IOP. Read more.
FDA approves MiSight contact lens to slow myopia progression in children
The MiSight contact lens (CooperVision) is a disposable, soft lens that is limited for one-time use and is not for wearing overnight. Read more.
FDA approves Novartis’ Beovu for wet AMD
Beovu (brolucizumab-dbll), also known at RTH258, demonstrated noninferiority vs. aflibercept in the phase 3 HAWK and HARRIER clinical trials and is the first FDA-approved anti-VEGF to maintain wet AMD patients on a 3-month dosing interval after a 3-month loading phase. Read more.
FDA approves Regeneron’s Eylea for diabetic retinopathy
The approval was based on results of the phase 3 PANORAMA trial, which enrolled 402 patients to investigate Eylea’s effect on the improvement of moderately severe to severe non-proliferative diabetic retinopathy compared with sham injection. Read more.