Electroretinogram as a Screening Tool to Assess Vigabatrin-Induced Retinal Toxicity in Children With Infantile Spasms.

PURPOSE: To assess the utility of electroretinogram (ERG) as a screening tool for vigabatrin-induced retinal toxicity in children with infantile spasms. METHODS: This was an observational cohort study including children with infantile spasms receiving treatment with vigabatrin. A 30-Hz flicker potential ERG, using the RETeval system (LKC Technologies), was done at baseline before starting vigabatrin at 6 months and 1 year. The amplitudes were recorded. RESULTS: Eleven children were included in the study. The most common etiologic factor for infantile spasms was tuberous sclerosis (36.4%) followed by West syndrome (27.3%). The mean age of the children was 7.14 ± 2.9 months, with a range of 3 to 16 months. The mean difference in amplitude was 3.21 ± 2.45 and 5.72 ± 4.18 µV at 6 and 12 months follow-up, respectively (P < .001). Eight of the 11 children (72.7%) showed vigabatrin-induced retinal toxicity, and all 8 children were receiving vigabatrin for more than 6 months. CONCLUSIONS: ERG can be used for vigabatrin-induced retinal toxicity monitoring in children with infantile spasms. Vigabatrin-induced retinal toxicity is related to the duration of treatment rather than cumulative dosage. [J Pediatr Ophthalmol Strabismus. 20XX;X(X):XXX-XXX.

Global experience of faricimab in clinical settings - a review.

INTRODUCTION: Faricimab is a bispecific antibody that acts to reduce neoangiogenesis in exudative retinal vascular disorders. It is approved for use in neovascular age-related macular degeneration and diabetic macular edema. We review the published efficacy and safety of faricimab in clinical settings. AREAS COVERED: A comprehensive literature review was conducted. Based on the 14 published real-world studies, 1127 patients (1204 eyes) were treated with faricimab. The majority of studies (14) included pre-treated patients. Most studies (13) showed central macular thickness improvement. However visual acuity improved in only half of the studies analyzed. Four studies demonstrated an extension of the treatment. Only 4 eyes (0.33%) reported intraocular inflammation and 3 eyes (0.24%) reported retinal pigment epithelial tear. EXPERT OPINION: The clinical experience with faricimab to date has the potential to provide a stable visual outcome with reduced treatment burden in cases that are resistant to other approved anti-VEGF agents. There are no major safety concerns based on this data analysis.

Preparing for the next decade of anti-VEGF biosimilars for retinal diseases: a focus on South Asia.

INTRODUCTION: South Asian countries such as India, South Korea, and Japan have played a key role in spearheading the research and development of biosimilars of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab for retinal diseases. It is important to understand how this region is preparing for the next decade in the field of anti-VEGF biosimilars for retinal diseases. AREAS COVERED: We discuss the existing anti-VEGF ranibizumab biosimilars along with the biosimilars that might receive approval in the coming decade. Furthermore, we discuss the development status of aflibercept biosimilars that might receive approval as soon as the aflibercept patent expires. EXPERT OPINION: The South Asian region seems to be well prepared, with multiple ranibizumab and aflibercept biosimilars in the pipeline. However, it has to be seen whether these therapies will have widespread global clearance or will simply obtain approval from the Asian regional authorities.

Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey).

PURPOSE: To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe. METHODS: A 16-question online survey was created in English and distributed between Dec 01, 2021 and Jan 31, 2022. A total of 112 respondents (retinal physicians) from the US and Europe participated. RESULTS: The majority of the physicians (56.3%) were familiar with anti-VEGF biosimilars. A significant number of physicians needed more information (18.75%) and real world data (25%) before switching to a biosimilar. About one half of the physicians were concerned about biosimilar safety (50%), efficacy (58.9 %), immunogenicity (50%), and their efficacy with extrapolated indications (67.8 %). Retinal physicians from the US were less inclined to shift from off-label bevacizumab to biosimilar ranibizumab or on-label bevacizumab (if approved) compared to physicians from Europe (p=0.0001). Furthermore, physicians from the US were more concerned about biosimilar safety (p=0.0371) and efficacy compared to Europe (p= 0.0078). CONCLUSIONS: The Bio-USER survey revealed that while the majority of retinal physicians need additional information regarding the safety, efficacy and immunogenicity when making clinical decisions regarding their use. Retinal physicians from US are more comfortable in continuing to use off-label bevacizumab compared to physicians from Europe.

Supplemental nutrition for retinal health: Evidence based analysis of commercial preparations in India.

Purpose: Antioxidants have been lately postulated as supportive and prophylactic supplements for various retinal disorders, especially age-related macular degeneration (AMD). Forty-eight brands of such supplements containing lutein and zeaxanthin are available in India. The aim of the study was to assess the market leaders in supplements for ophthalmology in view of AREDS recommendations. Methods: Descriptive review of top-selling supplements for eye health were compared to the contents of the AREDS-recommended levels. Results: None of the top 10 selling brands had exact or near similar composition as recommended in the AREDS-2 study, which is the most widely accepted level-1 evidence in AMD prevention. Conclusion: Physicians prescribing these antioxidants, especially for the prevention of advanced AMD, should be vigilant and aware of the contents of the prescribed brands.

Ranizurel safety evaluation in real-world -(RaSER) study.

PURPOSE: To assess the early real-world clinical outcomes regarding safety and efficacy after ranizurel administration. METHODS: A retrospective, consecutive, interventional, uncontrolled, multi-centre study was conducted incorporating data from four centres in India. 22 eyes with variable indications were included and all patients were treated with at least one intravitreal injection of ranizurel 0.5 mg between January 2021 and April 2021. Each patient underwent best-corrected visual acuity (BCVA) measurement with a Snellen chart (converted to LogMAR for analysis), central subfield thickness (CST) analysis with spectral-domain optical coherence tomography (SD-OCT) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at baseline and the last follow-up for evaluation of adverse events after ranizurel injection. RESULTS: - None of the sites reported any signs of inflammation, vasculitis or any other ocular or systemic adverse effects in any of the cases. Mean BCVA at baseline was 0.48 ± 0.26 LogMAR (20/63) which improved significantly 0.26 ± 0.28 (20/40) at the last follow-up. (p = 0.001) Mean CST at baseline was 448.4 ± 122.9 µm which improved significantly to 328.3 ± 89.9 µm. (p = 0.001). CONCLUSION: - The early real-world data from this limited series indicates that ranizurel is a safe alternative biologic for patients who were treatment-naive and in those who had undergone prior treatment with other anti-VEGF agents.