Luxturna, Rhopressa approvals lead FDA's recent ophthalmology news

In recent weeks, the FDA has issued three approvals for ophthalmic indications and multiple other rulings regarding ophthalmic drugs and technology.

Here is the most recent FDA-related ophthalmology news as reported on Healio.com/OSN:

FDA approves Luxturna for inherited retinal dystrophy

The FDA announced the approval of Luxturna to treat children and adult patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Read more.

Aerie Pharmaceuticals announces FDA approval of Rhopressa

Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. Read more.

FDA approves Omidria for pediatric patients
Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution) prevents intraoperative miosis and reduces postoperative pain during cataract surgery or IOL replacement. Read more.

Santen’s intravitreal sirolimus for noninfectious posterior segment uveitis not approved

A complete response letter to the NDA “requests additional substantiating evidence to demonstrate the efficacy” of intravitreal sirolimus in treating adults with noninfectious uveitis of the posterior segment. Read more.

FDA issues warning letter to maker of homeopathic eye drops

The drops, which are marketed for use in “red and irritated eyes” and “allergy eyes,” were deemed by the FDA to be at risk of microbial contamination because of “significant violations of current good manufacturing practice (CGMP) regulations.” Read more.

FDA allows Glaukos to begin IDE trial for iStent SA

The iStent SA trabecular micro-bypass system is indicated as a standalone procedure to reduce IOP in pseudophakic patients who have previously undergone cataract surgery and who have mild to moderate primary open-angle, pigmentary or pseudoexfoliative glaucoma. Read more.

FDA accepts supplemental biologics license application for 12-week dosing of Eylea

The FDA has accepted a supplemental biologics license application from Regeneron for a 12-week dosing interval of Eylea for patients with wet age-related macular degeneration. Read more.