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Eyenovia Inc. entered into an agreement with Formosa Pharmaceuticals whereby Eyenovia acquired the exclusive US rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), which is currently under review by the FDA. The agency assigned a Prescription Drug User Fee Act action date for APP13007 of March 4, 2024. Per the terms of the agreement, Eyenovia will make single-digit million-dollar payments to Formosa in cash and shares of Eyenovia common stock upon the signing of the agreement, upon FDA approval of APP13007 and the transfer of the NDA to Eyenovia and following the first commercial sale of APP13007. Formosa will also be eligible for payments related to the attainment of sales milestones by Eyenovia.
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Lupin Limited, a transnational pharmaceutical company based in Mumbai, India, announced it received approval from the FDA for its abbreviated new drug application for Bromfenac ophthalmic solution, 0.09% for the treatment of postoperative inflammation and pain after cataract surgery. Bromfenac is a generic equivalent of Bromday ophthalmic solution, 0.09% (Bausch + Lomb) and will be manufactured at Lupin’s Pithampur facility in India.
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Rayner announced the completion of the first implantations in two pivotal market access studies in the United States (involving Rayner's RayOne EMV Toric IOL) and China (involving Rayner's trifocal IOLs). Rayner’s RayOne EMV Toric IOL received Investigational Device Exemption approval from the FDA in June. The first study implantation took place at Vance Thompson Vision in Sioux Falls, S.D. This clinical trial, a prospective, multicenter, randomized, masked and active controlled study, aims to generate positive results that will support a pre-market approval submission to the FDA.
- Sandoz released positive results from the Mylight Phase 3 confirmatory efficacy and safety study (ClinicalTrials.gov NCT04864834) for its biosimilar aflibercept for patients living with wet macular degeneration. The Mylight Phase 3 study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of BCVA from baseline to week 8 between the biosimilar aflibercept and the reference biologic. Safety, immunogenicity and pharmacokinetics results confirmed that there is no clinically meaningful difference between the products. Sandoz expects to file for regulatory approval for biosimilar aflibercept in the United States in the coming months.
News
Quick Notes: August 18, 2023
Eyenovia acquires US commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa; Lupin receives approval from FDA for Bromfenac ophthalmic solution, 0.09%; and more.
Ophthalmology Management
August 18, 2023