Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.

INTRODUCTION: The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). METHODS: This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses). RESULTS: Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated. CONCLUSION: Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns. TRIAL REGISTRATION: CTRI/2020/09/027629, registered on 07 September 2020.

Evaluation of post-operative dry eye in upper and lower eyelid reconstruction: A cross-sectional study.

Purpose: In cases of eyelid malignancies requiring full thickness excisional biopsy followed by reconstruction of the created defect, the Meibomian glands are lost. Post-operative varying degrees of dry eye disease (DED) are expected in such patients. The aim was to evaluate the objective and subjective statuses of DED in cases of full thickness eyelid reconstruction following excisional biopsy because of malignancies. Methods: This was a cross-sectional pilot study. Objective and subjective dry eye parameters are assessed in cases of full thickness eyelid reconstruction following excisional biopsy because of malignancies in 37 eyes at 6 months post-operative follow-up. Analysis of variance and Chi square test were used for statistical analysis. Results: When compared with fellow eye, all the parameters were found to be statistically significant (P < 0.0). Subjective assessment of dry eye by ocular surface disease index (OSDI) scoring did not corroborate with the objective data (p 0.00). Lower eyelid reconstruction showed a minimum number of dry eye cases (P > 0.05). Conclusion: Prevalence of post-operative dry eye is more with increasing percentage of full thickness upper eyelid reconstruction. Disparity was found between objective and subjective parameters of dry eye in patients requiring varying percentages of upper eyelid reconstruction because of malignancies.

Study of Retinal Nerve Fibre Layer Thickness and Visual Contrast Sensitivity in HIV Positive Individuals.

INTRODUCTION: Measurement of Retinal Nerve Fibre Layer Thickness (RNFLT) by Optical Coherence Tomography (OCT) is a sensitive, non invasive and cheap method of detecting early retinal changes in a variety of diseases. In HIV infection, RNFLT is altered and this may have effect on other visual functions like Contrast Sensitivity (CS) and visual acuity. Such ocular pathology can affect the daily life and profession (especially driving) of HIV infected individuals. However, studies on this topic in HIV infected population are rare from India. AIM: To study RNFLT, CS and their correlation in a sample of HIV positive Indian population. MATERIALS AND METHODS: The present cross-sectional study was done in a tertiary care medical college hospital of Eastern India between May 2016 and September 2016. We did this study on HIV positive subjects with no clinically apparent ocular infection or other pathology. In this study, we have measured the RNFLT using the HRA-OCT Spectralis machine. The CS was tested using a smartphone version of the Pellie-Robson chart. CD4 count, visual acuity and colour vision were also tested. The data was analysed using SPSS version 20.0 for any correlation between these parameters. Pearson coefficient was used for continuous data and Spearman rank correlation was used for categorical data. A p-value <0.05 was considered significant. RESULTS: We had 17 patients, that is 34 eyes. RNFLT loss was found in 21% of the eyes and borderline thinning was found in a further 26%. Predominantly, the temporal quadrant was involved. The mean of log CS was 1.33±0.38. Taking 1.5 as the cut-off value for normalcy, 47% of the eyes tested showed decreased CS. Log CS showed significant correlation with RNFLT of the temporal quadrant only (r=0.37; 95% C.I. 0.041 to 0.631; p=0.02). Temporal RNFLT also showed statistical correlation with the CD4 count. The low CS was also significantly correlated with low visual acuity (r=0.5). CONCLUSION: In HIV infected persons, subtle ocular changes may occur and this may affect visual functions quite early. Hence, a comprehensive eye check-up should include parameters like CS and OCT.

Paraneoplastic optic neuritis as the first manifestation of periampullary carcinoma.

Paraneoplastic optic neuritis is a rare phenomenon that often presents as a diagnostic challenge. It has been mostly reported with small cell cancers or thymoma. Prompt treatment of the malignancy is the only effective therapy for the condition. Visual loss, once established usually becomes irreversible. We here report a case of paraneoplastic optic neuritis in a 40-year-old female with periampullary carcinoma. This is probably the first report of this association in the medical literature.

Influence of zeolite crystal size on zeolite-polyamide thin film nanocomposite membranes.

Zeolite-polyamide thin film nanocomposite membranes were coated onto polysulfone ultrafiltration membranes by interfacial polymerization of amine and acid chloride monomers in the presence of Linde type A zeolite nanocrystals. A matrix of three different interfacial polymerization chemistries and three different-sized zeolite crystals produced nanocomposite thin films with widely varying structure, morphology, charge, hydrophilicity, and separation performance (evaluated as reverse osmosis membranes). Pure polyamide film properties were tuned by changing polymerization chemistry, but addition of zeolite nanoparticles produced even greater changes in separation performance, surface chemistry, and film morphology. For fixed polymer chemistry, addition of zeolite nanoparticles formed more permeable, negatively charged, and thicker polyamide films. Smaller zeolites produced greater permeability enhancements, but larger zeolites produced more favorable surface properties; hence, nanoparticle size may be considered an additional "degree of freedom" in designing thin film nanocomposite reverse osmosis membranes. The data presented offer additional support for the hypothesis that zeolite crystals alter polyamide thin film structure when they are present during the interfacial polymerization reaction.