Aflibercept 16-Week Dosing Regimen for Diabetic Retinopathy Under Review
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
Category: Ophthalmic Disorders
Trial Investigating New Vuity Dosing Option for Presbyopia Meets Endpoint
Positive topline results were announced from a phase 3 study evaluating the twice daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. The multicenter, double-masked, randomized, vehicle-controlled parallel-group VIRGO study (ClinicalTrials.gov…
Xipere Now Available for Macular Edema Associated With Uveitis
Xipere® (triamcinolone acetonide injectable suspension) is now available for suprachoroidal use for the treatment of macular edema associated with uveitis. The approval of Xipere was based on data from the phase 3 PEACHTREE trial (ClinicalTrials.gov…
Lastacaft Eye Drops Now Available Over-the-Counter
Lastacaft® (alcaftadine ophthalmic solution 0.25%) is now available for sale over-the-counter (OTC). In December 2021, the Food and Drug Administration (FDA) approved the prescription to OTC switch for Lastacaft, an H1 histamine receptor antagonist. The…
FDA Approves Disposable Contacts With Antihistamine for Allergic Conjunctivitis
The Food and Drug Administration (FDA) has approved Acuvue® Theravision with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) for the prevention of ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia…
First Generic Version of Restasis Gets FDA Approval
The Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05% single-use vials (eye drops), the first generic version of Restasis. Cyclosporine ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated to increase…
Visomitin Gets Orphan Drug Status for Leber Hereditary Optic Neuropathy
The Food and Drug Administration (FDA) has granted Orphan Drug designation to visomitin for the treatment of Leber hereditary optic neuropathy (LHON), a rare genetic disease characterized by the degeneration of retinal ganglion cells that…
Tyrvaya Nasal Spray Now Available for Dry Eye Disease
Tyrvaya (varenicline solution) nasal spray is now available for the treatment of signs and symptoms of dry eye disease. Tyrvaya contains varenicline, a highly selective nicotinic acetylcholine agonist, which stimulates natural tear film production by…
FDA Approves First Eye Drop to Treat Presbyopia
The Food and Drug Administration (FDA) has approved Vuity (pilocarpine HCI ophthalmic solution) for the treatment of presbyopia in adults. Vuity is a cholinergic muscarinic receptor agonist designed to improve near and intermediate vision without…
Xipere for Suprachoroidal Use Approved for Macular Edema Associated With Uveitis
The Food and Drug Administration (FDA) has approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. The approval was based on data from the multicenter, randomized,…