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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…
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…
Aviceda Launches Phase 2 Clinical Trial for AVD-104
Aviceda Therapeutics announced a significant milestone in the development of its lead ophthalmic candidate, AVD-104, with the enrollment of the first patient in the GLYCO phase 2 US clinical trial. The trial aims to evaluate the efficacy and safety of…
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…
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…
How to Deal with the Epithelial Herpetic Keratitis
Trifluridine eye drop, acyclovir (ACV) ointment, ganciclovir gel, and oral ACV are still the main therapeutic agents. Cryopreserved amniotic membrane has been recently used as an adjuvant treatment. Resistance to ACV has become a concerning issue. The animal models of…
EyeBio Raises $130M for Restoret Development
EyeBio announced the successful completion of an extension to its Series A financing, resulting in a total raised amount of $130 million to date. The funding will be utilized by EyeBio to accelerate the company’s clinical development program and expand…
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…
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…