Top 10 ophthalmic FDA approvals of 2018

A host of new drugs and procedures entered the ophthalmic sphere in the past year with the FDA approving treatments for application in subspecialty areas of glaucoma, retina/vitreous, cornea/external disease, refractive surgery and cataract surgery.

Here are 10 of the most-read FDA approvals on Healio.com/OSN in 2018:

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

Oxervate, cenegermin, developed by Dompé farmaceutici SpA, is the first FDA approved drug for the rare disease, which can cause loss of corneal sensation and impair corneal health. Read more.

 

Xelpros gains FDA approval for open-angle glaucoma, ocular hypertension

Xelpros (latanoprost ophthalmic solution 0.005%) is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology. Read more.

 

FDA approves ReLEx SMILE for myopia with astigmatism

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision. Read more.

 

FDA approves Dexycu to treat cataract surgery inflammation

The treatment uses Icon’s Verisome drug delivery technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye. Read more.

 

FDA approves Hydrus microstent

The approval of the MIGS device was based on the results of the HORIZON trial, which included 556 mild to moderate glaucoma patients who underwent cataract surgery. Read more.

 

FDA approves Sun Pharma’s dry eye treatment

Cequa, cyclosporine ophthalmic solution 0.09%, the highest FDA-approved concentration of cyclosporine A and the first to incorporate nanomicellar technology, is indicated to increase tear production. Read more.

 

FDA approves Eylea 12-week dosing for wet AMD

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

 

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

Inveltys, loteprednol etabonate ophthalmic suspension 1%, is the first twice-daily ocular steroid for the treatment of inflammation and pain after ocular surgery to be approved by the FDA. Read more.

 

FDA approves Dextenza for treatment of postoperative ocular pain

Dextenza, dexamethasone ophthalmic insert 0.4 mg, is the first FDA-approved intracanalicular insert to deliver dexamethasone to treat postoperative ocular pain for up to 30 days with one treatment. Read more.

 

FDA approves Yutiq for chronic noninfectious uveitis

The FDA received clinical data from two randomized, sham injection-controlled, double-masked, phase 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares after 6 months and 12 months. Read more.

A host of new drugs and procedures entered the ophthalmic sphere in the past year with the FDA approving treatments for application in subspecialty areas of glaucoma, retina/vitreous, cornea/external disease, refractive surgery and cataract surgery.

Here are 10 of the most-read FDA approvals on Healio.com/OSN in 2018:

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

Oxervate, cenegermin, developed by Dompé farmaceutici SpA, is the first FDA approved drug for the rare disease, which can cause loss of corneal sensation and impair corneal health. Read more.

 

Xelpros gains FDA approval for open-angle glaucoma, ocular hypertension

Xelpros (latanoprost ophthalmic solution 0.005%) is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology. Read more.

 

FDA approves ReLEx SMILE for myopia with astigmatism

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision. Read more.

 

FDA approves Dexycu to treat cataract surgery inflammation

The treatment uses Icon’s Verisome drug delivery technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye. Read more.

 

FDA approves Hydrus microstent

The approval of the MIGS device was based on the results of the HORIZON trial, which included 556 mild to moderate glaucoma patients who underwent cataract surgery. Read more.

 

FDA approves Sun Pharma’s dry eye treatment

Cequa, cyclosporine ophthalmic solution 0.09%, the highest FDA-approved concentration of cyclosporine A and the first to incorporate nanomicellar technology, is indicated to increase tear production. Read more.

 

FDA approves Eylea 12-week dosing for wet AMD

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

 

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

Inveltys, loteprednol etabonate ophthalmic suspension 1%, is the first twice-daily ocular steroid for the treatment of inflammation and pain after ocular surgery to be approved by the FDA. Read more.

 

FDA approves Dextenza for treatment of postoperative ocular pain

Dextenza, dexamethasone ophthalmic insert 0.4 mg, is the first FDA-approved intracanalicular insert to deliver dexamethasone to treat postoperative ocular pain for up to 30 days with one treatment. Read more.

 

FDA approves Yutiq for chronic noninfectious uveitis

The FDA received clinical data from two randomized, sham injection-controlled, double-masked, phase 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares after 6 months and 12 months. Read more.