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Celltrion announces phase 3 trial data for EYDENZELT
(Image credit: ©HockleyM2) Celltrion recently announced 52-week findings from its global phase 3 clinical trial for its ophthalmic treatment candidate, EYDENZELT.1 EYDENZELT, a biosimilar of EYLEA (aflibercept), is Celltrion’s ophthalmic treatment candidate for the treatment of multiple retinal diseases, including…
Ashvattha reports positive phase 2 results for migaldendranib in DME and nAMD
(Image Credit: AdobeStock) Ashvattha Therapeutics shared positive topline data from its phase 2 study of migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). The topline end-of-study results were announced at the 25th…
Sight Science’s TearCare System earns spot in TFOS DEWS III dry eye report
(Image Credit: AdobeStock/tadamichi) Sight Sciences announced that its TearCare System has been included in the new Dry Eye Workshop (DEWS) III report from the Tear Film and Ocular Surface Society (TFOS) published in the American Journal of Ophthalmology.1,2 This marks the…
Outlook Therapeutics requests Type A meeting with FDA following second CRL for ONS-5010
(Image Credit: AdobeStock) Outlook Therapeutics has requested a Type A meeting with the US Food and Drug Administration following the agency issuing a complete response letter (CRL) to its biologics license application (BLA) resubmission for ONS-5010 (bevacizumab-vikg) for the treatment…
The state of retina at ASRS 2025 with Charles C. Wykoff, MD, PhD, and Kevin Quinn
(Image credit: AdobeStock/vetrana) The annual scientific meeting of the American Society of Retina Specialists (ASRS) was held in Long Beach, California from July 30 through August 2, 2025. At this event, researchers and experts in the retina field shared data…
EMA grants Orphan designations to MCO-010, FDA grants RMAT in Stargardt disease
(Image credit: AdobeStock/Pete) The European Medicines Agency (EMA) granted Orphan designations to MCO-010 (sonpiretigene isteparvovec) across 5 categories of retinal dystrophies. The US Food and Drug Administration (FDA) also granted RMAT designation for MCO-010 in Stargardt disease (SD). The EMA…
Oculis to Present Clinical Trial Results in Diabetic Macular Edema and Acute Optic Neuritis at Ophthalmology Conferences – The Manila Times
Oculis to Present Clinical Trial Results in Diabetic Macular Edema and Acute Optic Neuritis at Ophthalmology Conferences The Manila Times Source: Author: | Date: 2025-09-01 08:15:00 Source: Author: | Date: 2025-09-01 08:15:00
Oculis to Present Clinical Trial Results in Diabetic Macular Edema and Acute Optic Neuritis at Ophthalmology Conferences – Yahoo Finance
Oculis to Present Clinical Trial Results in Diabetic Macular Edema and Acute Optic Neuritis at Ophthalmology Conferences Yahoo Finance Source: Author: | Date: 2025-09-01 08:00:00 Source: Author: | Date: 2025-09-01 08:00:00
FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Outlook Therapeutics’ biologics license application (BLA) resubmission for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD). The recent CRL included only 1 deficiency, for…
Michael X. Repka, MD, MBA, on building consensus and future directions
In advance of the upcoming CCOI Myopia Workshop, scheduled for September 8 in Paris, France, Michael X. Repka, MD, MBA—program co-chair of the event and current president of the American Academy of Ophthalmology—spoke about the challenges and opportunities facing the…