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Spryte’s nOCT Tech Gets FDA Breakthrough Device Designation
Spryte Medical announced that its Neuro Optical Coherence Tomography (nOCT) technology has been awarded Breakthrough Device Designation by the FDA. This designation highlights the potential of nOCT to revolutionize neurointervention and cerebrovascular treatment. FDA Breakthrough Device Designation The FDA’s Breakthrough…
Eyenovia and Senju Collaborate on Novel Dry Eye Treatment
Eyenovia, a leading ophthalmic company, announced a collaboration agreement with Senju Pharmaceutical to develop SJP-0035, a corneal epithelial wound healing candidate, using Eyenovia’s Optejet® dispensing technology for chronic dry eye disease treatment. Strategic Collaboration for Innovative Treatment Under the agreement,…
Oertli Receives FDA Clearance for Faros Anterior System
Oertli Instrumente AG announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its globally established Faros anterior cataract surgery system. This milestone underscores Oertli’s expansive global presence and unwavering commitment to delivering advanced and reliable…
Trial Results for Susvimo Show Sustained Efficacy in DME and DR
Genentech and Roche released compelling 2-year data from the phase 3 Pagoda and Pavilion studies evaluating Susvimo (ranibizumab injection) 100 mg/mL, marking a significant development in the treatment landscape for diabetic macular edema (DME) and diabetic retinopathy (DR). Reintroduction of…
Okyo Pharma’s Phase 2 Trial for Neuropathic Corneal Pain
Okyo Pharma announced its plan to initiate a phase 2 clinical trial for OK-101 in the treatment of neuropathic corneal pain (NCP), scheduled to begin in the third quarter of 2024. This one-year study follows promising results from preclinical animal…
NexThera Submits IND Application for NT-101 for Wet AMD
NexThera has officially submitted a Phase 1/2a Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NT-101, an innovative non-invasive eye drop treatment targeting wet age-related macular degeneration (wet AMD). Proprietary Delivery Platform: Advancing Treatment…
ENTOD Pharma Introduces New Eye Drop Preservative System
Mumbai-based ENTOD Pharmaceuticals has unveiled a novel advancement in ophthalmic care with the introduction of EyeBS, a new eye drop preservative system. EyeBS is specifically designed to supplant traditional detergent-based preservatives such as Benzalkonium Chloride (BAK) and Polyquaternium-1, offering a…
Study Highlights Significant Drug Waste from SUCD for Eye Drops
A recent report published online in Ophthalmology reveals alarming levels of drug wastage and associated costs due to self-imposed use cessation dates (SUCD) for multiuse eye drop bottles. John M. Tan and colleagues from the Icahn School of Medicine at…
FDA Clears Enhanced SPECTRALIS® OCTA Module by Heidelberg
Heidelberg Engineering announced the FDA clearance of its upgraded SPECTRALIS® OCTA Module featuring SHIFT technology. This advancement promises to significantly reduce acquisition time by 50%, marking a pivotal development in clinical efficiency and diagnostic precision within ophthalmology. Enhancing Clinical Utility…
Sydnexis Appoints Perry J. Sternberg as CEO
Sydnexis, Inc., a pioneering biopharmaceutical company dedicated to addressing pediatric myopia progression, has appointed Perry J. Sternberg as its Chief Executive Officer and as a member of its Board of Directors. Sternberg, a seasoned pharmaceutical and biotech executive with over…