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

PurposeTo evaluate the anatomical and functional outcome of patients with traumatic submacular hemorrhage (SMH).MethodsA 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.ResultsTwenty 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).ConclusionMinimally non-invasive procedure including intravitreal r-tpa and gas appear to be effective in the displacement of post-traumatic SMH.

Choroidal osteoma is a rare benign tumor. We report a male child diagnosed with bilateral choroidal osteoma, high myopia and secondary choroidal neovascularization (CNV) membrane in one eye. Co-existence of posterior staphyloma made the clinical diagnosis of choroidal osteoma difficult due to the osteoma filling the depression of the posterior staphyloma. Typical findings on fundus fluorescein angiography, optical coherence tomography, B-scan and indocyanine green angiography confirmed the diagnosis. A review of literature was performed. CNV secondary to choroidal osteoma was treated with intravitreal bevacizumab and it responded well. Regular follow-up is essential for recurrence of CNV and decalcification of the osteoma.

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.

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