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FDA Warns Amazon Over Sale of 7 Unapproved Eye Drops
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has issued a warning letter to e-commerce giant Amazon.com regarding the introduction of unapproved ophthalmic drug products into interstate commerce. The FDA’s warning, delivered in a…
CHMP Backs Bayer’s High-Dose Eylea for Retinal Diseases
Bayer announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a high-dose formulation of the renowned eye drug Eylea for the treatment of wet age-related macular degeneration and…
VSY Biotechnology to Introduce a Novel Anti-VEGF for AMD
VSY Biotechnology GmbH is proud to announce the groundbreaking development of Varliciment, a revolutionary anti-VEGF agent for the treatment of age-related macular degeneration (AMD). Varliciment distinguishes itself from existing anti-VEGF agents like brolucizumab, namely Novartis’ Beovu, by being non-generic. This…
Blind Canvas Project by Ora and BlindCAN Film Festival
Ora and the BlindCAN Film Festival have jointly unveiled The Blind Canvas Project, an initiative that leverages the capabilities of storytelling and generative artificial intelligence (AI) to cultivate a more profound comprehension of the lives and narratives of individuals affected…
Pantheon Receives $2.5M Funding for Corneal Implant
Pantheon Vision has secured $2.5 million in seed financing from KeraLink International (KLI), a Baltimore-based non-profit organization dedicated to eliminating corneal blindness, with a specific focus on low- and middle-income countries. This funding will launch the development bioengineered corneal implant.…
Ocular Therapeutix Gets FDA Agreement for Wet AMD Trial
Ocular Therapeutix has obtained written FDA approval for the comprehensive design of its pivotal phase 3 clinical trial, known as the SOL trial, which evaluates Axpaxli (axitinib intravitreal implant) for treating wet age-related macular degeneration (AMD) under a Special Protocol…
FDA Greenlights Phase 1 Trial for IOPCL Magnifier
OnPoint Vision has officially received FDA approval for their investigational device exemption (IDE) application, initiating the phase 1 in the pivotal clinical trial for the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG). This trial focuses on the secondary implantation…
Novartis CEO Denies Ophthalmology Unit Sell-off Rumors
At the J.P. Morgan Healthcare Conference, Novartis CEO Vas Narasimhan denied rumors that the pharmaceutical giant is planning to sell its respiratory and ophthalmology units altogether. The rumors, which have been circulating for several weeks, suggested that Novartis was looking…
Novartis Initiates Sale of Ophthalmology Assets
According to sources familiar with the matter, Novartis AG is kicking off the process of selling some of its ophthalmology assets in order to prune its portfolio and concentrate on other therapeutic areas, including hematology, immunology, solid tumors, neurology, and…
Bausch + Lomb Acquires Eye Drugs from Novartis
Bausch + Lomb has announced that it will acquire the dry eye drug Xiidra (lifitegrast ophthalmic solution) 5% from Novartis. Xiidra is an eye drop without steroids that has received specific approval for treating the signs and symptoms of dry…