News

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.

Research needed to establish best diagnostic and management strategies for increasingly common condition.

The new PDUFA goal date for NT-501 as treatment for macular telangiectasia type 2 (MacTel) is March 18, 2025.

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.

Harrow has announced an initiative to expand access and affordability for its ophthalmic pharmaceutical products.

ARVN001 is indicated for the treatment of uveitic macular oedema and certain other ophthalmic indications

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 incidence was comparable to that of daily wear soft contact lenses

Gregg T. Kokame, MD, MMM, FASRS, is set to share data from a predefined subgroup of the sozinibercept Phase 2b wet AMD trial related to patients with polypoidal choroidal vasculopathy (PCV), measured at 24 weeks.

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.

ARVN001 is indicated for the treatment of uveitic macular edema (UME) and certain other ophthalmic indications under development.

OPUVIZ, previously known as the biosimilar candidate SB15, has been approved for the treatment of nAMD, DME and other retinal diseases

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.

A discussion with Shigeru Kinoshita, MD, PhD; and Edward J. Holland, MD.

This year’s Barcelona meeting brought together award-winning research findings and leaders in the retina field.

The positive opinion marks a key regulatory step towards the approval of FYB203, which will go by the trade names AHZANTIVE and Baiama in the European Union

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

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

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.

The CRL comes in response to a supplemental New Drug Application for Izervay, a treatment for geographic atrophy secondary to age-related macular degeneration

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

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

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