Geographic Atrophy

The agency confirmed its June 2024 negative opinion after Apellis requested re-examination of EMA's initial opinion.

Oral gildeuretinol demonstrated a clinically meaningful reduction in the geographic atrophy lesion growth rate at 24 months, supporting additional clinical development. SAGA topline data has been accepted as a late breaker at the 128th annual meeting of the American Academy of Ophthalmology, being held October 18-21 in Chicago.

According to the company, the pilot study showed procedural feasibility of ophthalmic artery angioplasty in the treatment of vascular lesions associated with geographic atrophy (GA).

BI 771716, with technology licensed from CDR-Life, is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology.

Ophthalmologists can use OCT to find the early signs of disease

PAS-nomacopan is a long-acting bispecific inhibitor of C5 and leukotriene B4 for intravitreal treatment of geographic atrophy (GA).

According to the company, additional data from its Phase 2 ARCHER trial showed both vision protection in standard and low light conditions, and structural protection in regions of the eye key for visual acuity.

According to the company, OCU410 utilizes an adeno-associated virus platform for the retinal delivery of the RORA gene.

Researchers train deep learning model on OCT scans to ID patients eligible for GA trials.

Researchers from the UKB Eye Clinic, in cooperation with the University of Bonn and in close collaboration with basic and clinical scientists, have examined patients with early forms of AMD. The researchers focused on the so-called iRORA lesions, which are very early anatomical signs of retinal damage.

Comanagement is a key component for treatment of disease.

Durga Borkar, MD, MMCi, recently discussed the quality data (Qdata, Verana Health) gathered on geographic atrophy as well as the GATHER 1 and GATHER 2 data.

Apellis plans to seek re-examination, with a final opinion expected in fourth quarter of 2024.

Repeated 0.1-ml intravireal injections of lampalizumab, antigen-binding fragment of a humanized monoclonal antibody that inhibits complement factor D, seem to be associated with a low risk of elevated IOP

4D-175 will be evaluated in the GAZE clinical trial, an upcoming phase 1, open-label trial.

The retrospective real-world evaluation of the drug considered several important as-yet-unanswered questions

Positive data from the GALE long-term extension study showed patients developed fewer new scotomatous points with 36 months of both continuous monthly and every-other-month treatment.

The primary endpoint for the ReNEW and ReGAIN trials is the rate of change in the macular area of photoreceptor loss assessed by spectral domain-optical coherence tomography (SD-OTC) and ellipsoid zone mapping at week 48.

Ocugen is developing OCU410 as a 1-time gene therapy for the treatment of geographic atrophy. It utilizes an AAV delivery platform for the retinal delivery of the ROR Related Orphan Receptor A gene.

The hypothesis is based on a post hoc analysis of data from 2 phase 3 clinical trials of pegcetacoplan by Dun Jack Fu, PhD, and colleagues.

Data can clear a path to trends and strategies to meet patients’ needs

The company reported that statistically significant data was found supporting ANX007’s ability to provide vision loss protection in patients with geographic atrophy.

Kamuvudine-8, also known as K8, is administered to the back of the eye via a sustained released intravitreal implant.

According to the company, a subretinal injection of ATSN-201 was well tolerated in all patients in the first cohort with extensive resolution of schisis observed in 2 patients. Safety data from the first cohort of the LIGHTHOUSE study will be presented at the Retinal Cell and Gene Therapy Innovation Summit 2024 being held May 3, 2024, in Seattle.

Researchers found the model demonstrated “near-perfect” detection capabilities.

According to the company, OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA gene.

Since its U.S. launch in September 2023, more than 40,000 avacincaptad pegol intravitreal solution vials have been distributed to physician practices.

The Phase 2 trial tested whether inhibiting microglia with minocycline might help slow GA expansion and its corresponding vision loss.