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The company noted the updated PDUFA goal date is February 26, 2023. The FDA also reiterated that they do not plan to hold an advisory committee meeting to discuss the application.

According to the company, LBS-008 is an orally administered tablet intended as an early intervention to slow disease progression in patients affected with Stargardt disease and dry age-related macular degeneration.

Delaying the disease can also delay any onset of vision problems, including diabetic retinopathy and diabetic macular edema.

According to the company, ROP Check builds upon its pediatric retina screening portfolio, adding digital management (schedule, document, bill, and transfer) for treating patients with retinopathy of prematurity.

Artificial intelligence in a primary care and clinic settings increases the likelihood of catching diabetic retinopathy in underinsured patients, resulting in increased successful referrals.

Being able to visualize and evaluate the retinal periphery provides a better understanding of the disease status and supports a better treatment decision.

OPT-302 in combination with standard-of-care anti-VEGF-A agents shown to improve visual acuity, anatomic endpoints.

In both patients and controls, investigators measured retinal nerve fiber layer thickness, foveal avascular zone area, and vessel density in the superficial capillary plexus, deep capillary plexus, and radial peripapillary capillary plexus.

The submission of 24-month efficacy data from DERBY and OAKS is classified as a Major Amendment to the New Drug Application, which delays the PDUFA target action date until February 2023.

An end-of-week review of retina news and stories from October 29-November 3, 2022.

RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions.

In a real-world setting, eyes with AMD with a relatively good initial best-corrected visual acuity and no fibrovascular pigment epithelial detachment sustained or improved BCVA after anti-VEGF therapy within 3 years of follow-up.

A previously uncharacterized area of the protein known as RPE65 spontaneously turns spiral-shaped when it encounters intracellular membranes, or thin structures that surround different parts of a cell.

The Sailing study was a 12-month, 18-center, randomized, double-masked, double-sham, parallel-controlled, phase 3 trial that was conducted in China and included eyes with center-involved DME that were randomly assigned to undergo either laser photocoagulation followed by as-needed sham intravitreal injections or sham laser photocoagulation followed by as-needed 0.5 mg intravitreal injections of conbercept.

Genentech announced this week that faricimab-svoa (Vabysmo) achieved its primary endpoint of non-inferiority compared to aflibercept in RVO in the BALATON and COMINO clinical trials.

In this retrospective, non-comparative clinical study, the investigators evaluated the preoperative, intraoperative, and postoperative data of the 225 study patients (295 eyes; mean patient age, 56.1 years) collected from several European centers.

The company noted that the pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE.

According to a study, health disparities impact the rates of pediatric ophthalmology visits.

Data highlights need for educational materials and training resources in DME and DR.

In this cross-sectional study, investigators used OCTA to identify possible associations between body mass index and the waist-to-hip ratio with macular vessel density and foveal avascular zone in healthy Chinese adults.

The company noted that testing of a commercial supply of the implants, which included exposing them to multiple punctures with a needle, found they did not meet their standards. The company has notified the FDA, and is working with the agency on the recall process.

Investigators conducted a longitudinal study of the relationship between smoking and smoking intensity and the rate with which the retinal nerve fiber layer becomes thinner in patients with primary open-angle glaucoma.

The investigators suggested that the predicted metastasis-free survival for metastatic tumors may be worse than what they and other research groups have observed.

Anti-VEGF therapy for ROP has potential ocular and systemic advantages compared with laser but also noted that the systemic risks of anti-VEGF therapy in these infants need to be quantified.

MCO-010, an ambient-light activatable multi-characteristic opsin optogenetic monotherapy for vision restoration in blind patients, received fast track designation from the FDA.

The goal of World Sight Day, according to IAPB, is “to shine a light on blindness and vision impairment as a major, but solvable, public health issue."

Vision loss and depression are common conditions with major health implications. However, the mechanism of that association remains to be clarified.

According to data released at the American Academy of Ophthalmology's 2022 annual meeting, a large number of wet AMD patients do not return for treatment.

Investigators reported that intravitreal steroid injections were the bases for more cases of endophthalmitis compared with other intravitreal injections.

The investigators undertook a study to determine the incidence of rhegmatogenous retinal detachments 1 year after cataract using the IRIS Registry data and to determine the demographic features, ocular comorbidities, and intraoperative factors associated with an increased risk of detachment development.