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ImprimisRx Wins $34.9M Trademark Case Against OSRX
In a landmark decision, a California jury unanimously ruled in favor of ImprimisRx in its trademark infringement lawsuit against OSRX and its related entity Ocular Science, according to a press release. The jury awarded ImprimisRx a total of $34.9 million…
Avirmax Launches ABI-110 Gene Therapy Trial for Wet AMD
Avirmax Biopharma has reached a major milestone in its mission to revolutionize the treatment of wet age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV) by successfully dosing the first patient in the phase I/IIa clinical trial of ABI-110, the…
Adverum Shares Positive Ixo-vec Results for Wet AMD
Adverum Biotechnologies has released promising 52-week topline results from its Phase 2 LUNA trial and new 4-year data from the Phase 1/2 OPTIC study for its gene therapy candidate Ixo-vec (AAV.7m8-aflibercept), targeting wet age-related macular degeneration (AMD). Transformative Potential of…
EO2002: Non-Surgical Solution for Corneal Edema
Emmecell has announced positive results from its U.S. multicenter Phase 1 trial evaluating EO2002, an innovative non-surgical cell therapy for corneal edema. The randomized, double-masked trial demonstrated significant improvements in best corrected visual acuity (BCVA) and reductions in central corneal…
Positive Phase 3 Results for MELT-300 Sedation
Melt Pharmaceuticals has reported promising topline results from the pivotal Phase 3 trial of MELT-300, a novel, non-intravenous, non-opioid sedation tablet developed for use during cataract surgeries. The study, conducted under an FDA-approved Special Protocol Assessment (SPA) agreement, demonstrated that…
Ocugen Shares Positive OCU410 Trial Results for GA
Ocugen has released encouraging preliminary findings from the Phase 1 portion of its Phase 1/2 OCU410 ArMaDa clinical trial, focused on treating geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The results demonstrate the potential of OCU410 as…
FDA Awards Designations to Gildeuretinol for Stargardt
Key Takeaways • Gildeuretinol (ALK-001) has received Rare Pediatric Disease and Fast Track designations, alongside prior Breakthrough Therapy and Orphan Drug statuses, emphasizing its potential to transform treatment for Stargardt disease. • Data from the TEASE-1…
EC Approves Opuviz, Eylea Biosimilar
Samsung Bioepis and Biogen have announced that the European Commission (EC) has approved Opuviz 40 mg/mL for injection. This biosimilar, also known as SB15, references the widely used treatment Eylea (aflibercept). The approval encompasses a range of retinal conditions, providing…
Eyenovia Pediatric Myopia Trial Falls Short
Eyenovia has announced that its Phase 3 CHAPERONE study, aimed at treating pediatric progressive myopia, failed to meet its primary endpoint. The trial evaluated the company’s proprietary drug-device combination using low-dose atropine delivered via the Optejet platform. A review by…
Cequa Shows Positive Phase 4 Results for Dry Eye
Sun Pharmaceutical has shared new Phase 4 clinical trial data, showcasing the efficacy of Cequa (cyclosporine ophthalmic solution) 0.09% in treating dry eye disease (DED). The results reveal that Cequa provides sustained improvements in patients whose symptoms were inadequately managed…