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Rocklatan approval tops recent FDA ophthalmology news
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From new drugs to new indications for existing drugs, the FDA has approved multiple products in the ophthalmology sphere in the first half of 2019.
Here are the top five most-read FDA approval articles on Healio.com/OSN from January through June:
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 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.
FDA approves Avaclyr for herpetic keratitis
Avaclyr (acyclovir ophthalmic ointment 3%), a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is indicated to treat dendritic ulcers in patients with HSV-1 and HSV-2. Read more.
FDA approves Lotemax SM for postoperative pain, inflammation
Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%) delivers a submicron particle size that dissolves faster in tears than Lotemax Gel (loteprednol etabonate ophthalmic gel 0.5%) and provides double the penetration to the aqueous humor. Read more.
FDA approves generic loteprednol etabonate from Akorn
The FDA has approved an abbreviated new drug application for Akorn’s loteprednol etabonate ophthalmic suspension 0.5%. Read more.