News

The CHMP has recommended FYB203 for approval in Europe for treating adult patients with age-related neovascular macular degeneration (nAMD) and other serious retinal diseases.

Cerebral/cortical visual impairment (CVI) is a leading cause of childhood blindness, caused by brain damage to visual pathways. Researchers are refining its definition and diagnostic methods to improve early detection and treatment, enhancing outcomes for affected children.

Avant Technologies and Ainnova Tech have partnered to develop a low-cost retinal camera integrated with Ainnova’s Vision AI platform for early detection of ocular and systemic diseases. The technology will be marketed as a SaaS platform for primary care settings.

After closing, the combined company is expected to operate under the name Kalaris Therapeutics, Inc.

Both LUNA and OPTIC were designed to assess a broad wet AMD population, including hard-to-treat patients with severe disease who required frequent anti-VEGF injections before enrolling in the trial.

The California Institute for Regenerative Medicine has funded Keck School of Medicine of USC translational research advancing a therapy for dry age-related macular degeneration, one of the leading causes of blindness in older adults.

A Q&A with PPP Committee Cornea/External Disease Panel member Daniel S. Choi, MD.

Melt Pharmaceuticals announced positive results from its Phase 3 study of MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. The results support a regulatory submission, with potential to revolutionize sedation practices in various medical specialties.

The EnVision Summit, co-founded by Bonnie An Henderson, MD, is a unique family-oriented, multispecialty ophthalmology CME conference, along with a newly introduced optometry track. Henderson sits down with Ophthalmology Times to talk about the 2025 conference that will take place February 14 to 17 at the Caribe Hilton San Juan, in Puerto Rico.

A PDUFA decision date of April 2, 2025 has been assigned

SpyGlass Pharma completed enrollment in a Phase 1/2 trial evaluating its drug delivery platform for glaucoma and ocular hypertension. Designed for implantation during cataract surgery, the platform delivers bimatoprost to lower intraocular pressure for up to 3 years.

Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.

Key findings include reduced lesion growth, retinal tissue preservation, and improved visual function, demonstrating significant potential for the treatment option.

The designations underscore the unmet need in Stargardt disease, a rare and serious pediatric disease for which no treatment exists.

The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15.

This retrospective cohort study was designed to provide further information on the association between BP parameters and VF progression over time.

Emmecell announced positive Phase 1 extension study results for EO2002, a nonsurgical cell therapy for corneal edema. The therapy improved vision, reduced central corneal thickness, and demonstrated strong safety, offering an alternative to corneal transplants.

Retreatment rates are lower, with few orbit decompression procedures.

This Week in Ophthalmology is a weekly video series highlighting the latest news and articles featured on the Ophthalmology Times website.

A coalition of eye health advocacy groups vocalized support for the legislation

HelpMeSee’s Mazava Project trains general practitioners in Madagascar to perform cataract surgeries, addressing the country’s high rate of avoidable blindness. Trainees gain proficiency through simulation-based learning and live surgeries, improving access to eye care in remote areas.

Livionex, recently announced a successful end-of-Phase 2 meeting with the FDA, supporting the advancement of C-KAD, a 2.6% EDTA ophthalmic solution, to a Phase 3 clinical study. In an interview with Ophthalmology Times, Randall Olson, MD, lead author and a Distinguished Professor at the University of Utah, Chair of the Department of Ophthalmology and Visual Sciences, and CEO of the John A. Moran Eye Center, discusses the ongoing research.

Afqlir (aflibercept) is a 2 mg vial kit and pre-filled syringe for intravitreal injection.

Prevent Blindness has designated November 18 to 24, 2024, as the 5th annual Thyroid Eye Disease (TED) Awareness Week. The week aims to raise awareness of TED's symptoms, impact on vision and mental health, and new treatment options. Educational resources and expert-led episodes will support patients and healthcare professionals.

Sun Pharmaceutical presented Phase 4 data at ESCRS 2024 showing that cyclosporine ophthalmic solution 0.09% significantly improves dry eye disease symptoms and corneal staining in patients inadequately controlled on Restasis, with positive results observed through 12 weeks of treatment.

Program director and co-founder Bonnie An Henderson, MD, sits down with Ophthalmology Times to talk about how the annual conference is a unique blend of cutting-edge science, professional growth, and community. The 2025 conference will take place February 14 to 17 at the Caribe Hilton San Juan, in Puerto Rico.