Lupin, the leading worldwide pharmaceutical company, has reached two important benchmarks, enhancing its profile in the ophthalmology sector. The company stated that the United States Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1%. With this approval, Lupin can sell a generic counterpart to Pred Forte Ophthalmic Suspension, 1%, which was first created by AbbVie Inc. The assignment of a Competitive Generic Therapy (CGT) classification to Lupin, the first accepted applicant, grants 180 days of CGT exclusivity. The medication, which is indicated for treating steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior part of the globe, will be produced at Lupin's Pithampur factory in India.

Additionally, Lupin announced the conclusion of a worldwide Phase 3 clinical investigation on LUBT010, its biosimilar candidate to Lucentis, with success. The main goal of the study was to find out if LUBT010 and Lucentis were equally effective at improving vision in people with Neovascular Age-related Macular Degeneration (wet AMD). The results showed that both drugs were safe and did not cause any immune system problems.

Under the RaniEyes brand, Lupin has been marketing its ranibizumab biosimilar in India. Ranibizumab treats neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

Globally, the Phase 3 study included patients from India, the United States, the EU, and Russia. The study assigned 600 patients to receive either LUBT010 or Lucentis 0.5 mg as an intravenous injection once a month for 12 months. The results of this study will assist Lupin's applications for European Medicines Agency (EMA) and U.S. FDA marketing approval. 

Commenting on the completion of the trial, Dr. Cyrus Karkaria, President of Lupin Biotech said, “We are very pleased with the positive outcome of the global Phase 3 study, which marks yet another significant developmental milestone for our Lucentis  Biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs.”

“This achievement of our Biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab Biosimilar into the global Ophthalmic market, making a positive difference in the lives of our patients worldwide,” commented Mr. Nilesh Gupta, Managing Director, Lupin.