Safety and efficacy of Razumab™ (world's first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study.

BACKGROUND: Razumab™ (world's first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD. METHODS: This prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged ≥ 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. The patients received intravitreal biosimilar ranibizumab 0.5 mg every 4 weeks for 24 weeks. Safety endpoints included the incidence of adverse events (AEs), serious AEs (SAEs), and immunoreactivity after 6 months. The efficacy endpoints were the proportion of patients who lose fewer than 15 letters, increase in BCVA, change in central retinal thickness (CRT), and change in Visual Function Questionnaire-25 (VFQ-25) score, from baseline to 24 weeks. RESULTS: Of the 126 enrolled patients, majority (95.24%) of the patients received all 6 doses of biosimilar ranibizumab (total 3 mg). Nineteen AEs were reported (n = 16; 12.7%); majority (78.9%) were mild. There were no serious AEs reported, except one AE of death which was unrelated to the study drug. None of the patients discontinued the study due to an AE. The most common ocular AE was increase in intraocular pressure (4 events) and non-ocular AE was pyrexia (5 events). A total of 7.9% (10/126) patients prior to dosing and 7.1% (9/126) patients post-treatment were positive for anti-ranibizumab antibodies. No AEs suggestive of immunogenicity were noted. At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. In the ITT and PP populations, 31.20% and 32.76% patients, respectively, showed improved visual acuity by ≥ 15 letters. Significant improvements in BCVA (mean difference: 8.8, 9.2, p < 0.001 for ITT, PP) and VFQ-25 (8.5, 9.2, p < 0.001 for ITT, PP) were seen; CRT reduced significantly (125 µm, 119.3 µm, p < 0.001 for ITT, PP). CONCLUSION: Razumab™ (world's first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients. Trial registration CTRI/2016/03/006739. Registered 18 March 2016-Prospectively registered, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13141&EncHid=&userName=2016/03/006739.

Microbiological and Antibiotic Sensitivity Profile of Postoperative Endophthalmitis in a Tertiary Eye Care Hospital of North India.

INTRODUCTION: We describe the microbiological profile of postoperative endophthalmitis from northern India and analyse the pattern of antibiotic sensitivity which may have changed due to development of resistance secondary to overuse of antimicrobial drugs. MATERIALS AND METHODS: This is a retrospective study of postoperative endophthalmitis from January 2011 to December 2017 in a tertiary eye hospital of northern India. Any patient developing endophthalmitis within one year of any intraocular procedure was included in the study. According to severity, treatment with a trial of intravitreal antibiotic injections or core vitrectomy was decided. Ocular samples were collected which were either anterior chamber tap or vitreous biopsy and sent for microbiological examination. The samples were stained with Gram's and KOH stain and cultured on chocolate agar, blood agar, brain heart infusion broth and Sabouraud dextrose agar. RESULTS: A total of 545 patients of postoperative endophthalmitis were analysed which showed a male predilection (60.5%) with maximum patients between the age group 50-69 years. 292 patients (53.5%) were culture negative and 253 patients (46.4%) were culture positive. Most common organism identified was Staphylococcus in 73 patients followed by Pseudomonas in 48 patients. Staphylococcus species was most sensitive to vancomycin (97%) followed by amikacin (91%) followed by gentamicin and moxifloxacin (88% each). Pseudomonas was the second most common isolate which showed maximum sensitivity to imipenem (82%) followed by ciprofloxacin(60%). Polymicrobial infection was noted in 23 patients. The most common fungal isolate was aspergillus in 11 patients, followed by fusarium in 10 patients. CONCLUSION: Our study shows that gram positive bacteria are the most common organisms in postoperative endophthalmitis and are most sensitive to vancomycin, followed by gram negative bacteria which show increased sensitivity with imipenem than commonly used antibiotic - ceftazidime.

Refractive and Visual Outcomes after Scleral Fixated Intraocular Lens Implantation in Children with Ectopia Lentis.

INTRODUCTION: This study was conducted to report the refractive and visual outcome after Scleral Fixated Intraocular Lens (SFIOL) implantation in children with nontraumatic ectopia lentis. METHODS: Retrospective review of the medical records of 25 eyes of 15 patients who underwent SFIOL implantation in children with non-traumatic ectopia lentis. RESULTS: The mean best corrected visual acuity (BCVA) before SFIOL implantation was 1.07 ± 0.9 logMar units [median: 0.9, Interquartile range (ΙQR): 0.415 to 1.555] which improved to 0.41 ± 0.33 logMar units (median: 0.22, ΙQR: 0.180 to 1.555) at two months postoperative follow up. In phakic group, the mean spherical refraction preoperatively was -12.04 ± 7.82 DS (dioptre sphere) (IQR: +16 to -5.875) and postoperatively was +0.93 ± 2.67DS (IQR: -0.375 to +2). In aphakic group, the mean spherical refraction preoperatively was +12.22 ± 2.05 DS and postoperatively was +1.2 ± 1.9 DS. The mean total astigmatism preoperatively was -6.44 ± 4.95 DC (dioptre cylinder) (median: 6, IQR: -10.50 to +2) and postoperatively was -1.47 ± 0.98 DC (median: -1.5, IQR: -2 to - 0.625 ). The mean IOL induced astigmatism was -1.01 ± 0.95 DC (median -0.75, IQR: -1.33 to - 0.25). The spherical refractive equivalent was within 2 Diopter (D) of the target refraction calculated preoperatively in 20 eyes and in five eyes it was more than 2 D. CONCLUSION: SFIOL implantation is associated with good visual outcome with a significant improvement in the refractive error. However, a longer follow up is required to assess the change of refraction and the stability of the SFIOL.

Clinical profile and management outcomes of traumatic submacular hemorrhage.

PURPOSE: To evaluate the anatomical and functional outcome of patients with traumatic submacular hemorrhage (SMH). METHODS: A retrospective, interventional case series of patients presenting between January 2016 and April 2018 was carried out at 4 tertiary eye care centers of India. Medical records of the patients with a history of blunt trauma and SMH were retrospectively reviewed. The intervention done was any one of the following: pneumatic displacement with 0.3 ml of intravitreal gas [100% perfluoropropane (C3F8) gas], pneumatic displacement with intravitreal 0.3 ml of 100% C3F8 gas combined with 100 µg/0.1 ml of recombinant tissue plasminogen activator (r-tpa), pars plana vitrectomy (PPV) with subretinal r-tpa and gas tamponade. The primary outcome measures included change in visual and anatomical status. RESULTS: Twenty eyes of 20 patients with blunt trauma were analyzed. Thirteen patients had small size SMH, 5 patients had medium size SMH, and 2 patients had massive size SMH. Sixteen patients had a favorable functional outcome, and eighteen patients had favorable anatomical outcome. The size and duration of post-traumatic SMH did not significantly affect the anatomical (P = 0.123) or functional (P = 0.293) outcome in our study. The patients who presented with initial visual acuity of 6/60 or better showed better functional outcome, which was statistically significant (P = 0.007). CONCLUSION: Minimally non-invasive procedure including intravitreal r-tpa and gas appear to be effective in the displacement of post-traumatic SMH.

Surgical and visual outcomes of posterior dislocated lens fragments after cataract surgery during 5-years at a tertiary eye hospital of North India.

OBJECTIVE: To determine the surgical and visual outcomes of posteriorly dislocated lens fragments in the vitreous cavity in patients undergoing cataract surgery. METHODS: A total of 149 eyes of 149 patients from 2013 to 2018 were included in the study. The primary cataract surgery was performed either at the base hospital and its peripheral centres or referred from elsewhere. Pars plana vasectomy and nucleus removal was performed along with implantation of intraocular lens, wherever possible. Success was defined as best corrected visual acuity (BCVA) ≥ 6/12 at 3 months follow up. Poor visual outcome was defined as per WHO guidelines as BCVA ≤ 3/60. RESULTS: Posterior capsular rupture and dislocation into vitreous cavity most frequently occurred during phaco-fragmentation in cases of phacoemulsification and during nucleus delivery in cases of small incision cataract surgery. Early vitrectomy was performed within 3 days in 36.2% of cases and within 14 days in 63.8% of cases. Successful visual outcome was achieved in 85.2% of patients at 3 months follow up after vitrectomy. Iatrogenic retinal break occurred in five patients during vitrectomyand five patients had retinal detachment. Poor visual outcome was observed in 12eyes, out of which glaucomatous optic neuropathy seen in 5 cases, cystoid or diabeticmacular edema in 4 cases and age related macular degeneration in 3 cases. CONCLUSION: Posterior dislocation of lens can be successfully managed in majority of cases with vitreoretinal surgical intervention. The timing of vitrectomy whether performed early or late did not affect the visual outcome. The most important predictorof final visual acuity after PPV for retained lens fragments is a less complicated clinical course without any associated complications such as retinal detachment, cystoidmacula edema and glaucoma. Expertise of the primary cataract surgeon could not be assessed in this study, though surgeon grade with more experience is an important factor in the assessment of complications during the cataract surgery.

A rare case of scleral buckle infection with Curvularia species.

BACKGROUND: Scleral buckling is an established modality of treating retinal detachment. Being an external implant the buckle may be prone to infections. We report such a case with a delayed presentation and a rare etiology. CASE PRESENTATION: A 45 year old male presented with redness, foreign body sensation and discharge for one month in his right eye. The patient had undergone a retinal detachment surgery elsewhere 14 years back without any visual gain. Right eye demonstrated no perception of light and the best corrected visual acuity in the left eye was 6/6, N6. On downgaze an exposed and anteriorly displaced scleral buckle was identified with black deposits and mucopurulent material overlying the buckle. Scleral buckle removal was done. On microbiological examination Curvularia species was identified. Successful treatment with antifungals was done. CONCLUSIONS: Scleral buckle infection with dematiaceous fungi is a rare occurrence. To the best of our knowledge this is the first case report describing a buckle infection caused by the curvularia species.

Scleral buckle infection by Serratia species.

We describe a rare case of scleral buckle (SB) infection with Serratia species. A 48-year-old male with a history of retinal detachment repair with scleral buckling presented with redness, pain, and purulent discharge in the left eye for 4 days. Conjunctival erosion with exposure of the SB and scleral thinning was noted. The SB was removed and sent for culture. Blood and chocolate agar grew Gram-negative rod-shaped bacillus identified as Serratia marcescens. On the basis of the susceptibility test results, the patient was treated with oral and topical antibiotics. After 6 weeks of the treatment, his infection resolved.