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FDA Approves Modified Axpaxli Trial by Ocular Therapeutix
Ocular Therapeutix announced that the FDA has granted approval for a modification to the special protocol assessment (SPA) agreement for the pivotal phase 3 SOL clinical trial of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI). This modification marks a…
Hearing Loss is Rare in Tepezza Treatment for TED
A recent study, led by Dr. Raymond Douglas, MD, PhD, revealed that long-term hearing loss is a rare occurrence in individuals with normal audiometry at baseline following treatment with Tepezza [teprotumumab]. Published in the current issue of the prestigious journal…
Sandoz Acquires Coherus’ Ophthalmology Assets for $170M
In a strategic move aimed at strengthening its focus on oncology and alleviating debt, Coherus BioSciences has entered into a definitive agreement to divest its Cimerli (ranibizumab-eqrn) ophthalmology franchise to Sandoz for a total consideration of $170 million in cash,…
FDA Approval and Funding for ONS-5010
In a significant stride towards advancing its clinical development program for ONS-5010, Outlook Therapeutics has received written agreement from the FDA under a special protocol assessment (SPA) for the NORSE EIGHT clinical trial protocol. This trial aims to evaluate the…
FTC Clears Amgen’s Acquisition of Horizon Therapeutics
Amgen is set to proceed with its acquisition of Horizon Therapeutics after reaching an agreement with the Federal Trade Commission (FTC). This agreement clears the way for Amgen to complete its acquisition of Horizon Therapeutics, a deal valued at $27.8…
Allotex Receives Funding for Allogeneic Presbyopia Inlays
Allotex and SpA have announced the successful completion of the first close of their $30 million Series B financing. The funds raised will be utilized to further develop their technology aimed at treating refractive errors. The decision to invest in…
DigitalOptometrics Launches Real-Time Translation Service
DigitalOptometrics has unveiled a revolutionary solution to enhance patient care with the launch of “DOT” (DigitalOptometrics Translate), a real-time translation service designed to break down language barriers in the optometric industry. The innovative “DOT” technology facilitates seamless communication between eye…
iuvo BioScience Completes Acquisition of Promedica
iuvo BioScience, a prominent Partner Research Organization (PROTM), announced its successful acquisition of Promedica International, a California Corporation, specializing in ophthalmology-focused clinical Contract Research Organization (CRO) services. The strategic move is poised to create a global leader in delivering comprehensive…
FDA Approves ZEISS’ VISUMAX® 800 for Nearsightedness
The FDA has approved the VISUMAX® 800 equipped with SMILE® pro software from ZEISS. This state-of-the-art femtosecond laser technology is designed for the surgical treatment of nearsightedness, with or without astigmatism. The VISUMAX® 800 enters the U.S. market at a…
Ocuphire Pharma Gets FDA Nod for Dim Light Visual Acuity Trial
In a recent announcement, Ocuphire Pharma disclosed that it has secured approval from the U.S. Food and Drug Administration (FDA) under a special protocol assessment (SPA) for the clinical trial protocol and planned statistical analysis of its LYNX-2 phase 3…