RESUMO
Cataract surgery is constantly evolving with new techniques, machines, and procedures entering the lexicon. With the modernization, the cost of surgery is increasing with respect to the surgeon, patient, and the society. Early rehabilitation with modern minimal access techniques reduces the societal cost of intervention. Manual small-incision surgery is simple, safer, and cheaper when contrasted with the cost and steep learning curve of machine-driven surgeries. A nucleus of a normal size is 6 mm, which can be bisected; 3 mm longitudinal fragments can be removed through 3.5 to 4.5 mm incision, and a large nucleus of 9.0 mm can trisected and removed through 3.5 to 4.5 mm. The limbal tunnel incision is 3.5 mm, which is close to 2.8 mm phacoincision, so it gives all the advantages of modern phacosurgery. The search of an ideal technique for manual phaco-fragmentation leads us to this specially designed snare (designed by the first author AS) which can tackle any grade nucleus. The nucleus can be bisected or trisected with ease. The technique has been around for 2 decades. There is a small learning curve. The complications are few and can be minimized with practice and simulation. It is a safe, valid, repeatable, and generalizable surgical procedure.
RESUMO
Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin’s biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin’s biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin’s ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], ?3.3% to 5.4% and per protocol population: 1.2%; 95% CI, ?3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin’s ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin’s ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin’s biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis