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.

Safety and efficacy profile of intravitreal ranibizumab vs dexamethasone in treatment of naïve diabetic macular edema.

PURPOSE: To compare the safety and efficacy parameters of intravitreal ranibizumab vs intravitreal dexamethasone (IVD) in the treatment of patients with naïve diabetic macular edema (DME) in terms of best-corrected visual acuity (BCVA), central macular thickness (CMT), and possible complications like intraocular pressure (IOP) rise and cataract progression. METHODS: A hospital-based prospective and comparative study of naïve DME patients was conducted between November 2020 and October 2021 with a minimum follow-up (F/U) period of 6 months. Thirty phakic patients received one dose of IVD implant (Group A) and the other 30 (Group B) received three consecutive monthly doses of ranibizumab. The main exclusion criteria were steroid responders and the presence of ocular inflammation. RESULTS: The mean pre-injection CMT in Group A was 405µ and reduced to 297.07µ at 3 months and 278.35µ at 6 months. Mean increase in logMAR BCVA was 0.55. The mean pre-injection IOP was 16.28 and 17.64 mm of Hg at 6 months. In Group B, the mean pre-injection CMT was 401.07µ and reduced to 276.1µ at 3 months and 292.9µ at 6 months. Mean BCVA increased to 0.37. The mean pre-injection IOP was 17.28 mm Hg and 16.42 mm Hg at 6 months. There was no significant progression of cataract in both groups. CONCLUSION: The mean decrease in CMT was comparable in both the groups at 6 months F/U with an improvement of BCVA with no significant IOP fluctuation or cataract progression. Hence, IVD appears to be noninferior to ranibizumab in the treatment of naïve DME.

Multipiece posterior chamber intraocular lens as sutureless, glueless scleral fixated intraocular lens.

PURPOSE: The purpose of the study is to report the outcomes of sutureless, glueless multipiece posterior chamber intraocular lens (PCIOL) as scleral fixated intraocular lens (SFIOL) implantation in patients with poor or no posterior capsular support. METHODS: Medical records of 45 eyes of 42 patients who underwent SFIOL implantation where no suture or glue was used to fixate intraocular lens (IOL) to the sclera from November 2016 to October 2017, with minimum 18 months of follow-up were retrospectively analyzed. The best-corrected visual acuity, indication of surgery, other significant eye examination findings, and complications were analyzed. RESULTS: Out of 42 patients, 62% were males and 38% were females. Mean age of subjects was 48.5 ± 16.5 years (range 13-79 years). Mean preoperative and postoperative visual acuity was 1.48 ± 0.6 Logarithm of the Minimum Angle of Resolution (logMAR) units and 0.6 ± 0.3 logMAR units, respectively. Most common complication was vitreous hemorrhage six eyes (13.3%) followed by postoperative hypotony in five eyes (11.11%). Other complications such as transient postoperative intraocular pressure rise, hyphema, tilted IOL, cystoid macular edema, retinal detachment were also noted. CONCLUSION: Multipiece PCIOL used as SFIOL without any sutures and glue is a viable, cost-effective method of IOL implantation in eyes with aphakia following surgical complication or trauma, with comparable outcome to other techniques of SFIOL implantation.

Funduscopy-guided fluorescein angiography-free focal laser photocoagulation for central serous chorioretinopathy.

PURPOSE: To identify and correlate hypopigmented spots on fundoscopy with the leakage points on fluorescein angiography (FA) in patients with central serous chorioretinopathy (CSCR) to provide criteria for FA-free focal laser photocoagulation (FLP). METHODS: Fifty consecutive patients of acute CSCR were evaluated between March and October 2019 confirming the inclusion and exclusion criteria. Colocalization of leakage points with discrete hypopigmented spots on clinical fundoscopy was evaluated using FA. Positive predictive value (PPV) was calculated to identify the status of association between these to formulate criteria for FA-free FLP of CSCR patients in future. RESULTS: Out of the 50 eyes, 38 (76%) had a discrete hypopigmented spot on fundoscopy which coincided with the leakage point on FA. The PPV of finding a leakage point at the area of discrete hypopigmented spot is 95%. Colocalization with a pigment epithelial detachment was found in 25 (65.7%) of these 38 eyes. Retinal pigment epithelial irregularities were found associated in all of these 38 eyes. Subretinal homogenously hyperreflective material was found in 8 (21.05%) of 38 eyes. optical coherence tomography following FLP of leakage point in all cases showed complete resolution of CSCR in 47 (94%) eyes. CONCLUSION: This study demonstrates that hypopigmented spots on clinical fundus examination in CSCR patients, when present, coincide with the leakage point of FA. This may aid to undergo FA-free FLP treatment in CSCR patients.

Anterior chamber intraocular lens - An effective alternative in traumatic and surgical aphakia in the era of scleral-fixated intraocular lens.

Purpose: To evaluate outcomes of anterior chamber intraocular lens (ACIOL) implantation with vitrectomy in eyes with surgical or traumatic aphakia, and subluxated or dislocated lens. Methods: In this retrospective study, we evaluated patients who underwent pars plans vitrectomy with ACIOL implantation from April 2016 to March 2019. Patients with minimum follow-up period of 1 year and operated by single surgeon were included. Ophthalmic history, indication for surgery, BCVA, IOP, slit-lamp examination, and fundus assessment findings were noted. Postoperatively best-corrected visual acuity (BCVA), intraocular pressure (IOP) and complications if any were noted. Results: Ninety eyes of 88 patients were included in the study. The mean age of the patients was 60.2 ± 10.2 yrs. Majority (75.6%) were males and 24.4% were females. Indications for pars-plana vitrectomy (PPV) with ACIOL implantation were nucleus drop in 16.6%, IOL drop in 25.5%, large posterior capsular rupture (PCR) with vitreous disturbance or zonular dehiscence (ZD) during cataract surgery in 33.3%, more than 180° subluxation of lens in 10% and traumatic lens or intraocular lens (IOL) drop in 14.4% cases. Preoperative and postoperative mean Log MAR visual acuity was 1.59 ± 0.44 and 0.36 ± 0.33 respectively, with few complications like cystoid macular edema (CME) in 8.8%, persistently raised IOP in 4.4%, persistent uveitis in 2.2%, retinal detachment (RD) in 2.2%, and tilted IOL in 1.1% cases. Conclusion: Out of different options available for secondary IOL implantation in patients with poor capsular support ACIOL has the advantages of cost-effectiveness, small learning curve, faster surgical time with a lesser rate of complications like IOL tilt, vitreous hemorrhage, and suture erosion as compared to scleral-fixated IOL (SF-IOL). Comparable visual outcome can be obtained by proper patient selection in these cases.

Visual outcome of pars plana vitrectomy with intraocular foreign body removal through sclerocorneal tunnel and sulcus-fixated intraocular lens implantation as a single procedure, in cases of metallic intraocular foreign body with traumatic cataract.

AIM: To evaluate visual outcome following pars plana vitrectomy (PPV) and intraocular foreign body (IOFB) removal through the sclerocorneal tunnel combined with simultaneous cataract extraction and sulcus-fixated intraocular lens (IOL) implantation as a single procedure in penetrating ocular trauma with IOFB and traumatic cataract. MATERIALS AND METHODS: Eighteen cases of penetrating ocular trauma with retained IOFB and traumatic cataract who underwent PPV, IOFB body removal and cataract extraction with posterior chamber IOL (PCIOL) implantation in the same sitting, between June '04 and December '05 were retrospectively analyzed. All the foreign bodies were removed through the sclerocorneal tunnel. RESULT: All the 18 patients were young males, with an average follow-up period of 12 months. In 12 cases the foreign body was intravitreal and in six cases it was intraretinal but extramacular. Thirteen cases had a best corrected visual acuity ranging from 20/20 to 20/60 at their last follow-up. Five cases developed retinal detachment due to proliferative vitreoretinopathy (PVR) changes postoperatively and were subsequently managed by surgery. CONCLUSION: Primary IOL implantation with combined cataract and vitreo-retinal surgery is a safe option reducing the need for two separate surgeries in selected patients with retained IOFB and traumatic cataract. This combined procedure provides good visual outcome with early rehabilitation in young working patients.