News

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.

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.

A combination of posters, podium presentations, and instructional courses provided invaluable revelations to the ophthalmic community.

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.

Patients with a unilateral rhegmatogenous retinal detachment frequently ask about the risk of developing an RRD in their fellow eye.

Those who used both traditional and electronic cigarettes reported severe to very severe ophthalmic symptoms.

The AVONELLE-X long-term extension study will continue to evaluate the efficacy, durability, and safety of faricimab in patients with neovascular AMD.

The data analysis showed that the macular thickness decreased across all time periods and in all macular regions for all tertiles.

Janssen noted that results from Phase 1/2 MGT009 study demonstrate safety profile of investigational gene therapy botaretigene sparoparvovec (AAV-RPGR) and suggest sustained vision improvement in patients with X-linked retinitis pigmentosa.

The results also showed that, compared to use of systemic antivirals alone, treatment with adjunctive intravitreal injections or early pars plana vitrectomy did not affect the time to development of retinal detachments.