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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…
FDA Unveils Updated Guidance for Ophthalmic Drugs
The FDA has released a significant update for the pharmaceutical industry, unveiling a revised draft guidance titled “Quality Considerations for Topical Ophthalmic Drug Products.” This comprehensive guidance addresses crucial quality considerations for various ophthalmic drug products, including gels, ointments, creams,…
Top 10 Medical Devices in Ophthalmology
Medical technology has advanced significantly in recent years, providing numerous benefits to patients and healthcare professionals. In the field of ophthalmology, innovative medical devices have been developed that have revolutionized the way eye conditions are diagnosed and treated. Here are…
Azura Ophthalmics: Phase 2 Results for AZR-MD-001
Azura Ophthalmics reported positive top-line efficacy and safety outcomes from a phase 2 investigation of AZR-MD-001 in individuals experiencing Contact Lens Discomfort (CLD) due to challenges in comfortably wearing lenses and demonstrating signs of meibomian gland dysfunction (MGD). The trial…