Intravitreal Pegcetacoplan Gets Priority Review for Geographic Atrophy
Pegcetacoplan is a targeted C3 therapy that works by regulating excessive activation of the complement cascade.
Pegcetacoplan is a targeted C3 therapy that works by regulating excessive activation of the complement cascade.
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
The phase 3 VIRGO study evaluated the efficacy and safety of Vuity in adults aged 40 to 55 years of age with presbyopia.
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.
In December 2021, the FDA approved the prescription to OTC switch for Lastacaft.
Acuvue Theravision with Ketotifen reduced ocular itching within 3 minutes and the response was sustained for up to 12 hours after lens insertion.
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 is a cardiolipin peroxidation inhibitor designed to sustain and restore mitochondrial function and interrupt apoptosis in mitochondrial conditions.
Tyrvaya contains varenicline, a highly selective nicotinic acetylcholine agonist.
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.