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.

Functional evaluation of the macular area in early glaucoma using microperimetry.

Purpose: To evaluate the central visual field by microperimetry (MP), in early glaucoma. Methods: Consecutive perimetrically experienced patients with a single nasal step or arcuate scotoma and 14 control eyes underwent MP. Retinal sensitivity on MP was mapped for frequency and depth of loss in the central 10° around fixation. Results: Twenty-one eyes had a single nasal step and 19 eyes with single arcuate scotoma on standard automated perimetry (SAP), with central 10° being normal on 30-2 and 10-2 perimetry. The average mean sensitivity on MP, in glaucomatous and control eyes was 11.8 ± 3.9 dB and 16.6 ± 1.2 dB, respectively, P = 0.0004. The average mean defect on MP-1, in glaucomatous and control eyes was -6.5 ± 2.0 dB and -3.0 ± 1.2 Db, respectively, P = 0.05. The corresponding retinal hemisphere showed significant defects in MP. In eyes with single nasal steps, an absolute scotoma was seen in 14-28% of eyes 8-10° off fixation, moderate to mild defects were seen in 10-52% eyes, and 10% eyes showed involvement up to 4° from the fixation. Eyes with arcuate scotoma had an absolute scotoma on MP in 95% of eyes, 6-10° from fixation, with extension up to 2° from fixation in 21%. In glaucomatous eyes, the normal hemisphere on SAP showed a mild defect on MP in 43%. Control eyes did not show any defect in SAP or MP. Conclusion: A significant loss of central retinal sensitivity is recorded on MP in early glaucomatous neuropathy as compared to SAP. Paramacular absolute defects were seen at 6-10° from fixation.

Ocular spectrum of kite injury: A six-year trend at a tertiary eye care center.

Purpose: To assess ocular morbidity attributable to kites (patang) with emphasis on the cause, type and severity of the injury, complications, and final visual outcome. Methods: All the patients with a history of kite injury during months of Makar Sankranti for consecutive 6 years (2014-2019) were included in this study. A B-scan, orbital X-ray, and CT scan were performed for extensive ocular evaluation. Results: : Out of 68 patients with kite-related injury, 58 were male and 10 were female. Globe rupture (20), lid laceration (18), penetrating injury (9), wooden foreign body in the anterior or posterior chamber (7), superficial foreign body (4), hyphema (7), and vitreous hemorrhage (3) due to falling from height were noted. Factors associated with a poor final visual outcome in our study were poor initial visual acuity, globe rupture, intraocular foreign body, and development of endophthalmitis. Conclusion: Kites can cause serious preventable injuries mostly among pediatric males. The use of protective eyewear and public awareness can decrease ocular injury significantly.