Abecept is positive for non-proliferative diabetic retinopathy in phase 3 trials

Abecept is positive for non-proliferative diabetic retinopathy in phase 3 trials

March 20, 2018 Source: Sina Pharmaceutical

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On March 19, Renewables Pharmaceuticals said that the company's clinical phase 3 trial of PAYRAMA for the treatment of moderate to severe non-proliferative diabetic retinopathy by EYLEA® (aflibercept, absicept intraocular injection) reached 24 weeks. The main research endpoint. The results showed that 58% of patients receiving EYLEA experienced a two-step or higher improvement on the 24th week of the Diabetic Retinopathy Severity Scale (DRSS), compared with only 6% of patients receiving sham injections. The same improvement (p < 0.0001).

Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneratives, said: "This is the first time that a treatment has proven to reverse disease progression in patients with moderate to severe non-proliferative diabetic retinopathy without diabetic macular edema. A clinical program specifically targeted at these populations. Patients in the trial continue to be evaluated to determine if EYLEA can prevent progression of neovascular visual complications or diabetic macular edema. We look forward to sharing these results later this year."

Patients in the active treatment group received an average of 4.4 EYLEA injections during the first 24 weeks, with no new safety events. One patient developed mild intraocular inflammation (IOI), which was consistent with the incidence of IOI observed in previous clinical trials.

PANORAMA is an ongoing, randomized, double-blind, critical clinical phase 3 trial with a two-year trial. A total of 402 patients were enrolled in the study to compare the effect of EYLEA on moderate and severe NPDR in diabetic macular edema. The details of the clinical trial design were as follows: three treatment groups were the placebo injection treatment group and the two EYLEA treatment groups. The initial dose started in the EYLEA treatment group was three or five times a month. The trial will assess the efficacy of administration every 8 weeks or every 16 weeks for one year.

Both study endpoints evaluated the proportion of patients who experienced a two-step or greater improvement in the DRSS score. The first end is six months (24 weeks) and the second end is one year (52 weeks). DRSS is a systematic grading scale that assesses the severity of diabetic retinopathy based on retinal photographs after dilated eye examination. Secondary endpoints included assessment of whether EYLEA prevented neovascular complications (such as progression to proliferative diabetic retinopathy (PDR) and anterior neovascularization] or progression to diabetic macular edema (DME), and other anatomical effects of the drug , vision improvement and safety impact. Some secondary endpoints will be measured for up to two years.

The results of the PANORAMA trial will be made public at future medical conferences and will be used as the basis for supplementing the biopharmaceutical license application (sBLA) to the US FDA later this year.

Another ongoing, separate trial initiated by the Diabetic Retinopathy Clinical Research Organization is also conducting a clinical study of EYLEA for NPDR-free treatment with no DME.

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor administered by intraocular injection. By blocking two growth factors involved in angiogenesis (VEGF-A and placental growth factor PLGF), the drug can prevent the growth of new blood vessels and reduce the ability of ocular fluids to pass through blood vessels (vascular permeability). (Sina Pharmaceutical Compilation / David)

Article Reference Source: EYLEA® (aflibercept) Injection Demonstrates Positive Topline Results in Phase 3 Non-Proliferative Diabetic Retinopathy Trial

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