FDA News

FDA approves devices, drugs and dosing regimens

In August, the FDA approved devices, drugs and dosing regimens to treat a range of ocular indications, including glaucoma, dry eye, age-related macular degeneration, postoperative pain and inflammation, and neurotrophic keratitis.

 

FDA approves Inveltys for treatment of inflammation, pain after ocular surgery

The FDA has approved Inveltys, a twice-daily ocular corticosteroid, for the treatment of postoperative inflammation and pain after ocular surgery according to Kala Pharmaceuticals. Read more.

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

The FDA has approved Oxervate for treatment of neurotrophic keratitis, a progressive disease affecting the cornea. Developed by Dompé farmaceutici SpA, Oxervate (cenegermin) is the first FDA approved drug for the rare disease. Read more.

 

FDA approves Eylea 12-week dosing for wet AMD

The FDA has approved a supplemental biologics license application for a 12-week dosing schedule of Eylea injection in wet age-related macular degeneration patients, Regeneron announced. Read more.

 

FDA approves Sun Pharma s dry eye treatment

The FDA has approved Cequa for the treatment of dry eye disease, Sun Pharmaceutical Industries announced. The cyclosporine solution incorporates nanomicellar technology and is indicated to increase tear production. Read more.

 

FDA approves Hydrus microstent

Ivantis announced the FDA approval of the Hydrus microstent, designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. Read more.

In August, the FDA approved devices, drugs and dosing regimens to treat a range of ocular indications, including glaucoma, dry eye, age-related macular degeneration, postoperative pain and inflammation, and neurotrophic keratitis.

 

FDA approves Inveltys for treatment of inflammation, pain after ocular surgery

The FDA has approved Inveltys, a twice-daily ocular corticosteroid, for the treatment of postoperative inflammation and pain after ocular surgery according to Kala Pharmaceuticals. Read more.

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

The FDA has approved Oxervate for treatment of neurotrophic keratitis, a progressive disease affecting the cornea. Developed by Dompé farmaceutici SpA, Oxervate (cenegermin) is the first FDA approved drug for the rare disease. Read more.

 

FDA approves Eylea 12-week dosing for wet AMD

The FDA has approved a supplemental biologics license application for a 12-week dosing schedule of Eylea injection in wet age-related macular degeneration patients, Regeneron announced. Read more.

 

FDA approves Sun Pharma s dry eye treatment

The FDA has approved Cequa for the treatment of dry eye disease, Sun Pharmaceutical Industries announced. The cyclosporine solution incorporates nanomicellar technology and is indicated to increase tear production. Read more.

 

FDA approves Hydrus microstent

Ivantis announced the FDA approval of the Hydrus microstent, designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. Read more.