FDA starts 2017 with ophthalmic approvals, NDAs

The first quarter of 2017 saw new developments at the FDA for many ophthalmic drug candidates or technological developments.

Here are the top five most-read FDA news stories on Healio.com/OSN this quarter:

1. FDA approves Abbott’s iDesign for mixed astigmatism

Abbott’s iDesign Advanced WaveScan Studio System for mixed astigmatism in LASIK patients was approved in January. Read more.

2. FDA clears IND application for Aura Biosciences’ AU-011 for ocular melanoma

The light-activated targeted therapy AU-011, administered through an intravitreal injection, consists of viral nanoparticle conjugates that bind to cancer cells in the eye. Read more.

3. FDA accepts NDA resubmission for Dextenza

The new drug application resubmission for Ocular Therapeutix’s Dextenza for ocular pain after surgery was accepted in February. Read more.

4. Lucentis receives FDA approval to treat myopic choroidal neovascularization

This is the fifth FDA-approved indication approved for Genentech’s Lucentis (ranibizumab). Read more.

5. FDA approves study for Implantable Miniature Telescope in post-cataract patients

VisionCare’s Implantable Miniature Telescope is already approved for AMD patients who have not had cataract surgery. If approved, it would also be available for post-cataract patients. Read more.