[{"orgOrder":0,"company":"Formosa Pharmaceuticals","sponsor":"AimMax Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formosa Pharmaceuticals and AimMax Therapeutics to Present Phase 2 Trials Results of APP13007 for the Treatment after Cataract Surgery at ARVO 2022 Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Formosa Pharmaceuticals"},{"orgOrder":0,"company":"Formosa Pharmaceuticals","sponsor":"AimMax Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-301 for the Treatment of Inflammation and Pain after Cataract Surgery","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Formosa Pharmaceuticals"},{"orgOrder":0,"company":"Formosa Pharmaceuticals","sponsor":"AimMax Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Formosa Pharmaceuticals"},{"orgOrder":0,"company":"Formosa Pharmaceuticals","sponsor":"Eyenovia","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Eyenovia Acquires U.S. Commercial Rights to APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension, 0.05%) from Formosa Pharmaceuticals","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Formosa Pharmaceuticals"},{"orgOrder":0,"company":"Formosa Pharmaceuticals","sponsor":"Crist\u00e1lia","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Formosa Pharmaceuticals Announces Licensing Agreement with Crist\u00e1lia, for the Commercialization of APP13007 for the Treatment of Inflammation and Pain Following Ocular Surgery","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Formosa Pharmaceuticals"}]
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Under the agreement, Cristália gets exclusive Brazilian rights for the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension) for the treatment of inflammation and pain following ocular surgery.
Through the acquisition, Eyenovia has gained the exclusive U.S. rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension), a potent steroid for reducing the inflammation and pain associated with ocular surgery, which is under review by FDA.
APP13007 (clobetasol propionate ophthalmic nanosuspension) is expected to provide ophthalmologists and ocular surgery patients with a compelling, rapid and sustained, and more convenient postoperative anti-inflammatory and pain relief solution.
There were 26.5% of subjects who showed sustained anterior chamber cell (ACC) count = 0 (inflammation free) from post-operative day 8 (POD8) through POD15 in the APP13007 (clobetasol propionate) arm as compared to 5.1% in the placebo arm (p<0.001).
Data showed statisticallly-significant and clinically-meaningful improvement of inflammation and pain with twice-daily APP13007 compared to matching placebo, a regimen that is being evaluated in ongoing Phase 3 studies.