Sun Pharma Gets CDSCO Panel Nod for Additional Indication of Ranibizumab solution for injection
New Delhi: In line with the proposal presented by the drug major Sun Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the ophthalmic drug Ranibizumab solution for injection of 10 mg/ml for additional indications such as Diabetic Macular Oedema (DME), Macular Oedema following Retinal Vein Occlusion (RVO) and Visual Impairment due to Choroidal Neovascularization (CNV) secondary to Pathological Myopia (PM).
However, this approval is subject to the condition that the firm should conduct a Phase-IV study in Indian patients for the proposed indications.
This came after the pharmaceutical giant Sun Pharma presented the proposal to approve additional indications of Diabetic Macular Oedema (DME), Macular Oedema following Retinal Vein Occlusion (RVO) and Visual Impairment due to Choroidal Neovascularization (CNV) secondary to Pathological Myopia (PM) for the drug Ranibizumab solution for injection 10 mg/ml by way of extrapolation in line with the approved indications of innovator drug.
Diabetic macular edema (DME) is manifested as retinal thickening caused by the accumulation of intraretinal fluid, primarily in the inner and outer plexiform layers.
Retinal vein occlusion is a blockage of the veins carrying blood away from the retina. This can lead to swelling and fluid leakage. The result is an unwanted buildup of liquid at the back of the eye known as macular edema. If left untreated, the condition can blur vision and eventually lead to blindness.
Myopic choroidal neovascularization (CNV) is a complication of PM and is a serious threat to vision. CNV is observed as an abnormal growth of blood vessels located between the neurosensory retina and the retinal pigment epithelium. Symptoms include a decrease in vision, central scotoma, and/or metamorphopsia.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that binds human vascular endothelial growth factor A (VEGF-A) to prevent it from binding its receptors, thereby suppressing neovascularization. The mechanism of action of ranibizumab is similar to other VEGF-targeting therapies.
Ranibizumab is a medication used to manage and treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularization, and diabetic retinopathy.
At the recent SEC for Ophthalmology held on 19th December 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma for the proposal to approve additional indications of Diabetic Macular Oedema (DME), Macular Oedema following Retinal Vein Occlusion (RVO) and Visual Impairment due to Choroidal Neovascularization (CNV) secondary to Pathological Myopia (PM) for the drug Ranibizumab solution for injection 10 mg/ml by way of extrapolation in line with the approved indications of innovator drug.
After detailed deliberation, the committee recommended approval of the proposed additional indications i.e. Diabetic Macular Oedema (DME), Macular Oedema following Retinal Vein Occlusion (RVO), and Visual Impairment due to Choroidal Neovascularization (CNV) secondary to Pathological Myopia (PM) by way of extrapolation in line with the approved indications of innovator drug with a condition to conduct a Phase-IV study in Indian patients for the said indications.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within three months of approval for the proposed indication.
