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FDA approves abbreviated new drug application from Amneal Pharmaceuticals for bimatoprost ophthalmic solution 0.01% | Ophthalmology Times
(Image Credit: AdobeStock) The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL).1 An ANDA is a submission to the FDA that…
The European Commission grants marketing authorization for EYLUXVI | Ophthalmology Times
(Image Credit: AdobeStock) The European Commission (EC) has granted marketing authorization for EYLUXVI (ALT-L9), an aflibercept (Eylea) biosimilar from Alteogen, co-developed by its subsidiary, Alteogen Biologics.1 EYLUXVI is Alteogen’s second approved biosimilar; the other approval is the company’s trastuzumab (Herceptin) biosimilar. Alteogen received a…
Luxa Biotechnology announces clinical trial results for treatment of AMD | Ophthalmology Times
(Image credit: ©Alex_Traksel/AdobeStock) Luxa Biotechnology LLC announced results from its phase 1/2a clinical trial titled “Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation in Patients with Dry Age-related Macular Degeneration: Low Dose Clinical Outcomes.”1 The results were published…
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…
STAAR Surgical confirms expiration of “window shop” period in Alcon merger agreement | Ophthalmology Times
(Image Credit: AdobeStock/BOOCYS) STAAR Surgical announced the expiration of the 45-day “window shop” period under the terms of the previously announced merger agreement with affiliates of Alcon. Recently, STAAR filed a definitive proxy statement on the acquisition and has reached…
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,…
Palatin recieves $6.5 million milestone payment from partnership with Boehringer Ingelheim | Ophthalmology Times
Palatin Technologies announced the achievement of a research milestone under its collaboration with Boehringer Ingelheim, which triggers a €5.5 million ($6.5 million) payment to Palatin.1 The partnership was announced in August of this year2 and under the terms of the agreement,…
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,…
Q&A: Anat Loewenstein recaps the 2025 EURETINA meeting | Ophthalmology Times
Photo of Anat Loewenstein at EURETINA 2025 The 25th EURETINA conference was a landmark event, attracting 11,000 participants from around the world. Anat Loewenstein, MD, the 2025 The president of EURETINA, highlighted the meeting’s comprehensive scientific program, featuring sessions on…
Justis P. Ehlers, MD, on the HELIOS trial for NPDR | Ophthalmology Times
Note: Captions are generated with the assistance of AI. Justis Ehlers, MD, spoke with Ophthalmology Times to share key findings from his recent presentation at the 2025 Retina Society meeting, which was held in Chicago, Illinois. Ehlers shared data from…