Intravitreal Pegcetacoplan Gets Priority Review for Geographic Atrophy
Pegcetacoplan is a targeted C3 therapy that works by regulating excessive activation of the complement cascade.
Diagnosis & Disease Information
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.
Trial Investigating New Vuity Dosing Option for Presbyopia Meets Endpoint
The phase 3 VIRGO study evaluated the efficacy and safety of Vuity in adults aged 40 to 55 years of age with presbyopia.
Xipere Now Available for Macular Edema Associated With Uveitis
Xipere approval was based on data from the phase 3 PEACHTREE trial, which included 160 patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis.
Lastacaft Eye Drops Now Available Over-the-Counter
In December 2021, the FDA approved the prescription to OTC switch for Lastacaft.
FDA Approves Disposable Contacts With Antihistamine for Allergic Conjunctivitis
Acuvue Theravision with Ketotifen reduced ocular itching within 3 minutes and the response was sustained for up to 12 hours after lens insertion.
First Generic Version of Restasis Gets FDA Approval
Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Visomitin Gets Orphan Drug Status for Leber Hereditary Optic Neuropathy
Visomitin is a cardiolipin peroxidation inhibitor designed to sustain and restore mitochondrial function and interrupt apoptosis in mitochondrial conditions.
Tyrvaya Nasal Spray Now Available for Dry Eye Disease
Tyrvaya contains varenicline, a highly selective nicotinic acetylcholine agonist.
FDA Approves First Eye Drop to Treat Presbyopia
The approval was based on data from the phase 3 GEMINI 1 and GEMINI 2 studies that evaluated Vuity in a total of 750 patients aged 40 to 55 years with presbyopia.
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