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Presented at ASRS , results from the phase 2 ZETA-1 trial showed oral APX missed its primary endpoint, but the consideration of a binocular treatment effect may warrant further clinical development. The ZETA-1 trial is a multi-center, placebo-controlled, double-masked phase 2 trial, in which patients were randomized to receive BID mg APX or placebo.

The fellow eye criteria included any DRSS score and may have center-involved DME. A total of individuals with DR were enrolled in ZETA-1, with an average age of 56 years. Individuals in the APX group maintained their good vision compared to placebo. Safety assessments indicated a favorable ocular and systemic safety profile of oral APX Well-established evidence indicates the progression of DRSS is associated with an increased risk for vision loss and reinforces the need for the prevention of DRSS worsening to reduce the complications of DR.

The investigators suggest the efficacy and safety observed with APX as an oral treatment warrants further clinical development. Relevant disclosures for Dr. Lally include Apellis Pharmaceuticals, Genentech, Iveric Bio, Ocuphire, Regeneron, and others.

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News Media Medical World News Podcasts Shows State Of Sciences - Presentations Videos Webinars. In real-world practice, some retinal physicians may inject patients with mild disease to prevent them from going on to become worse.

However, trial data to date do not fully capture the benefit of this paradigm. Focal and grid laser therapy for the treatment of DME has largely been supplanted by anti-VEGF therapy due to superior visual outcomes and often vision gains rather than prevention of vision loss.

Studies have demonstrated the superior efficacy of anti-VEGF compared to laser in terms of visual gains. Therefore, for patients with significant central or parafoveal exudation or for those where monthly intravitreal injections may not be realistic, fluorescein angiography can be helpful to find leaking microaneurysms and to guide focal laser therapy, particularly if they are not subfoveal and if it is a single leaking microaneurysm, for instance in the temporal macula.

Nevertheless, anti-VEGF injections for DME remain the gold standard for the vast majority of cases in Although primary anti-VEGF intravitreal therapy allows tremendous vision gains, there remain nonresponders to anti-VEGF monotherapy, and other inflammatory biomarkers and signaling cascades create a multifactorial milieu beyond VEGF.

In January of , the Food and Drug Administration approved faricimab Vabysmo; Genentech , the first bispecific monoclonal antibody that simultaneously targets 2 key pathways: VEGF and angiopoietin-2 Ang2.

The YOSEMITE and RHINE clinical trials demonstrated noninferiority of intravitreal faricimab compared to aflibercept every 8 weeks, as well as the ability to extend patients up to 16 weeks.

We know that anti-VEGF is not the only pathway that can serve as a therapeutic target in patients with DR. Protocol U evaluated the impact of addition of intravitreal dexamethasone 0.

All patients received a loading dose of 3 ranibizumab injections and if they still met inclusion criteria, they were randomized to either combination ranibizumab and dexamethasone implant vs ranibizumab alone. After 6 months, there was not a statistically significant difference in average visual acuity gains between the combination group versus ranibizumab only — 3.

The percentage of patients with a gain of 15 letters or more from baseline at month 24 was Retina specialists are always concerned about patients with nonproliferative disease going on to have worse disease, whether this is the development of DME or PDR, and the associated complications. Patients with risk factors such as uncontrolled systemic A1c or conversion to PDR in the fellow eye are of particular concern.

Studies like PANORAMA demonstrated that patients with moderate-to-severe NPDR with or without DME treated with aflibercept had significantly greater improvement in the DRSS score compared with sham. This raises the question of whether retina specialists should initiate earlier treatment of patients with severe NPDR with anti-VEGF, regardless of DME status.

DRCR Retina Network Protocol W sought to answer this question. This study included eyes with moderate-to-severe NPDR without baseline CI-DME and randomized patients to either aflibercept injection or sham. The study found that patients in the aflibercept group were nearly threefold less likely to develop CI-DME with associated vision loss compared to sham, and over twofold less likely to develop PDR at the 2-year mark.

One point that is not always considered is that although the visual acuity outcomes were no different in Protocol W if treatment was withheld until conversion to PDR, the patient experience and journey if an acute onset of neovascular glaucoma or anterior segment rubeosis occurs with need for urgent treatment is not accurately depicted by focusing on visual acuity results only.

Our drug is an oral tablet that could be taken earlier in the disease progression. Kelley said a new drug called APX could provide relief for many of these patients. At IU School of Medicine, Kelley had originally licensed the drug to Apexian Pharmaceuticals for oncology development.

Following the completion of a safe phase 1 trial in oncology, the drug was then licensed to Ocuphire Pharma for back-of-the-eye diseases. Researchers recently completed a phase 2b trial on the APX About patients with diabetic retinopathy were randomized to receive either mg of the oral APX drug or a placebo daily over 24 weeks.

Kelley said those who received the drug did not experience as much worsening of vision loss as those who received the placebo.

There were also few side effects and no serious adverse events. Kelley said these results show the drug displays a strong safety profile as an oral drug and non-invasive option in protecting vision in both eyes for diabetic retinopathy patients.

Food and Drug Administration to get their advice in anticipation of advancing to a phase 3 trial of the drug. Learn more about APX and the phase 2 study results.

IU researchers find new drug to prevent progression to vision loss safe and effective for people with diabetes Christina Griffiths Feb 07, The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.

Retina specialists are always concerned about patients with nonproliferative disease going on to have worse disease, whether this is the development of DME or PDR, and the associated complications. Patients with risk factors such as uncontrolled systemic A1c or conversion to PDR in the fellow eye are of particular concern.

Studies like PANORAMA demonstrated that patients with moderate-to-severe NPDR with or without DME treated with aflibercept had significantly greater improvement in the DRSS score compared with sham. This raises the question of whether retina specialists should initiate earlier treatment of patients with severe NPDR with anti-VEGF, regardless of DME status.

DRCR Retina Network Protocol W sought to answer this question. This study included eyes with moderate-to-severe NPDR without baseline CI-DME and randomized patients to either aflibercept injection or sham. The study found that patients in the aflibercept group were nearly threefold less likely to develop CI-DME with associated vision loss compared to sham, and over twofold less likely to develop PDR at the 2-year mark.

One point that is not always considered is that although the visual acuity outcomes were no different in Protocol W if treatment was withheld until conversion to PDR, the patient experience and journey if an acute onset of neovascular glaucoma or anterior segment rubeosis occurs with need for urgent treatment is not accurately depicted by focusing on visual acuity results only.

Therefore, an individualized treatment approach is needed for NPDR; anti-VEGF therapy for NPDR without DME is not only an FDA-approved option but also a helpful option for the right patient. For physicians who do not typically offer treatment of NPDR without DME, one scenario that can help introduce this treatment option is to observe DRSS score regression in a patient with unilateral DME that has been treated and consider initiating treatment in the fellow eye with NPDR without DME.

This could be a helpful scenario for physicians who are contemplating introducing anti-VEGF to treat NPDR into their practice.

Treatment of diabetic eye disease has taken tremendous strides from an initial focus on treatment for DM to an expanded indication of DR without DME.

With the array of injectable medications available, the next step will be looking at durability and efficacy to alleviate some of the treatment burden patients have with frequent visits and injections. Just recently, results from the PHOTON study demonstrated the efficacy of high-dose aflibercept 8 mg for the treatment of DME.

Aside from injectable medications, oral medications for the treatment of diabetic retinopathy and DME have made waves in the retnina community. Studies such as Protocol W continue to investigate the pros and cons of intravitreal anti-VEGF treatment for NPDR.

Although a majority of retinal physicians may state they do not treat NPDR without DME, in we have increasing evidence and data to strongly consider anti-VEGF as a treatment option for appropriate cases, and encourage this discussion with patients with all the risks, benefits, and alternatives.

Early detection and treatment of NDPR, specifically DME, remains an important role for the retina specialist in preventing vision loss in patients with diabetes. Saagar A. Pandit, MD, MPH, is a second-year resident at the Wills Eye Hospital in Philadelphia, Pennsylvania.

Pandit reports no relevant disclosures. Michael Klufas, MD, is a retina specialist at the Wills Eye Hospital Retina Service and Mid-Atlantic Retina and an assistant professor of ophthalmology at Sidney Kimmel College of Thomas Jefferson University in Philadelphia.

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