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Idebenone accepted by FDA for priority review for Leber Hereditary Optic Neuropathy | Ophthalmology Times
(Image Credit: AdobeStock) The US Food and Drug Administration (FDA) has granted Priority Review to Chiesi Global Rare Diseases’ idebenone for Leber Hereditary Optic Neuropathy (LHON) Currently there are no clinically proven therapies for LHON in the US. Idebenone is…
Conavi Medical submits Novasight Hybrid IVUS/OCT System to FDA for 510(k) clearance | Ophthalmology Times
(Image Credit: AdobeStock/gguy) Conavi Medical has submitted its Novasight Hybrid™ IVUS/OCT intravascular imaging system to the US Food and Drug Administration (FDA) for 510(k) clearance for coronary applications. While optical coherence tomography (OCT) is traditionally used to monitor retinal diseases,…
OKYO Pharma details next clinical stage of urcosimod development | Ophthalmology Times
OKYO Pharma has announced its plans for the next stage of clinical development of urcosimod (formerly OK-101), its lead drug candidate to treat neuropathic corneal pain (NCP). NCP is a condition that causes severe pain and sensitivity of the eyes, face,…
Optos and Toku to incorporate BioAge AI into existing retinal imaging devices | Ophthalmology Times
(Image credit: AdobeStock/hakule) Optos and Toku have reached an agreement to make Toku’s BioAge available to users of Optos Daytona, Monaco, MonacoPro, and California devices in the United States. The companies state that by incorporating the AI solution, BioAge, eye…
Q&A: Robyn Guymer highlights risk factors of intermediate AMD | Ophthalmology Times
Photo of Robyn Guymer at EURETINA 2025 in Paris, France Professor Robyn Guymer from the University of Melbourne discussed intermediate age-related macular degeneration (AMD) at the 2025 EURETINA meeting. She explored risk factors for disease progression, focusing on optical coherence…
iVeena secures $2 million NEI SBIR grant to advance pediatric myopia therapy | Ophthalmology Times
iVeena Delivery Systems has been awarded a $2 million phase 2 Small Business Innovation Research (SBIR) grant from the National Eye Institute (NEI) of the National Institutes of Health (NIH). The funding will help to advance development of novel topical eye…
Christine Kay, MD, on the 152-week results of the RESTORE study for retinitis pigmentosa | Ophthalmology Times
Christine Kay, MD, a vitreoretinal surgeon and IRD specialist from Gainesville, Florida, presented the results of the RESTORE trial for MCO-010 optogenetic therapy for retinitis pigmentosa. The trial was a 152-week analysis of a novel gene therapy targeting bipolar cells.…
Horus Pharma selected as additional commercialization partner for aflibercept biosimilar in Europe | Ophthalmology Times
(Image credit: AdobeStock) Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), issued an additional semi-exclusive license agreement with Horus Pharma for the commercialization of FYB203/Baiama 2 in selected European countries.1…
David Almeida, MD, MBA, PhD, advances ophthalmic training with near real surgical specimens | Ophthalmology Times
David Almeida, MD, MBA, PhD, highlights near real surgical systems (NRSS), providing ophthalmologists with anatomically accurate models that replicate real surgical scenarios for training, research, and device development. (Image credit: AdobeStock/Iurii) A vitreoretinal surgeon and clinician-scientist with Erie Retina Research…
Kalaris enrolling phase 1b/2 study of TH103 for nAMD | Ophthalmology Times
(Image credit: ©kwanchaift/AdobeStock) Kalaris Therapeutics announced the company is currently enrolling a phase 1b/2 multiple ascending dose (MAD) study of TH103 for the treatment of neovascular age-related macular degeneration (nAMD).1 “The phase 1b/2 study represents an important milestone in advancing…