Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration.

PURPOSE: This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration (nAMD). DESIGN: This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study. PARTICIPANTS: A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239). METHODS: Patients received FYB201 or reference ranibizumab 0.5 mg by intravitreal (IVT) injection in the study eye every 4 weeks. MAIN OUTCOME MEASURES: The primary end point was change from baseline in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks before the third monthly IVT injection. Biosimilarity of FYB201 to its originator was assessed via a 2-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters. RESULTS: The BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters with a 90% confidence interval (CI) of -1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined equivalence margin. Adverse events were comparable between treatment groups. CONCLUSIONS: FYB201 is biosimilar to reference ranibizumab in terms of clinical efficacy and ocular and systemic safety in the treatment of patients with nAMD.

Management of diffuse choroidal hemangioma in Sturge-Weber syndrome with Ruthenium-106 plaque radiotherapy.

PURPOSE: To evaluate Ruthenium-106 plaque radiotherapy in the treatment of diffuse choroidal hemangioma (DCH) associated with serous retinal detachment. METHODS: A retrospective analysis was performed in five patients treated for DCH associated with Sturge-Weber syndrome (SWS). In all cases, Ruthenium-106 plaque therapy with a target apex dose of 30.98-47.36 Gy (mean:38.9 Gy) was performed. The outcomes of treatment were regression of DCH, assessed by B-scan ultrasonography; resolution of serous retinal detachment, measured by B-scan ultrasonography and optical coherence tomography (OCT); changes in best corrected visual acuity (BCVA) and the development of radiation-related complications. All investigations were repeated 3 months after treatment and then at six monthly intervals within 22-122 months (mean: 62 months) of follow-up. RESULTS: The initial BCVA of the affected eyes ranged from counting fingers at 1 m to 0.1 by the Snellen chart. Mean tumor basal diameter was 16.7 mm (range: 13.8 to 18.5 mm) and mean tumor thickness was 4.4 mm (range: 2.4 to 5.8 mm). Tumor regression was found in all cases with the prompt resolution of subretinal fluid. In three patients, BCVA improved and in two it remained stable. During the follow-up period, in one case secondary glaucoma was treated with transscleral cyclophotocoagulation, and in another case, recurrence of the hemangioma was treated with repeated Ruthenium-106 plaque irradiation and transpupillary therapy. CONCLUSION: Ruthenium-106 plaque radiotherapy is an effective and safe treatment option for DCH associated with SWS. Brachytherapy led to tumor regression and resolution of serous retinal detachments, and visual stabilization was achieved in most cases.

[Photodynamic therapy in a patient with chronic central serous chorioretinopathy--a case report]. / Terapia fotodynamiczna u chorego na przewlekla centralna surowicza chorioretinopatie--opis przypadku.

PURPOSE: The aim of the study was to evaluate the efficacy of photodynamic therapy as the treatment of chronic central serous chorioretinopathy. MATERIAL AND METHODS: A 59-year-old man was referred to the Department of Ophthalmology and Ocular Oncology, Jagiellonian University in Cracow with a complaint of recurrent visual acuity impairment in his left eye, which he had noticed for the first time three years earlier. The complete ophthalmic examination was extended by the additional diagnostic procedures of optical coherence tomography and fluorescein angiography and the patient was diagnosed with chronic central serous chorioretinopathy. He was eligible for the photodynamic therapy with a full dose of verteporfin, which was performed. The patient was subsequently re-assessed at 3 and 6 months following treatment completion. During the follow up assessment the amount of subretinal fluid on fundus examination and the best-corrected visual acuity (Snellen) were evaluated. The follow up optical coherence tomography was also performed. RESULTS: Six months after photodynamic therapy the subretinal fluid resolved completely, the distance best-corrected visual acuity improved from 0.2 to 0.5 and the near best-corrected visual acuity from 2.25 to 0.5. No treatment-induced adverse effects were observed. CONCLUSION: The photodynamic therapy may be effective in the management of selected cases with chronic central serous chorioretinopathy. central serous chorioretinopathy, photodynamic therapy.

A case of choroidal metastasis in a male breast cancer.

PURPOSE: We present a case of male patient under therapy due to breast cancer with choroid metastasis and exudative retinal detachment in right eye. MATERIAL AND METHODS: A 59 years old male patient was referred with diagnosis of intraocular tumor in right eye Three years ago radical right-side mastectomy was performed (T2N1M0). The medical history revealed that the patient was under chemo- and hormontherapy due to right breast cancer with lungs, liver and mediastinum metastases. Based on the ophthalmological examination the diagnosis of intraocular tumor was established--choroidal metastasis with exudative retinal detachment. Due to tumor size and general dissemination external beam irradiation of tumor was performed. CONCLUSIONS: The majority of choroidal metastases in males are secondary to lung carcinoma, however in differential diagnosis it is necessary to consider also rare cases of breast carcinoma metastases. Treatment strategy should be considered individual depending on size, localization, presence of metastases to other organs and general condition of the patient.

[Guidance for the treatment of neovascular age-related macular degeneration (AMD)]. / Wspólczesne metody leczenia wysiekowej postaci zwyrodnienia plamki zwiazanego z wiekiem (AMD).

BACKGROUND: Neovascular age-related macular degeneration (AMD) is becoming an increasing socio-medical problem as the proportion of the aged population is continuously increasing. However, new researches in the pathogenesis of the disease offer the opportunity to develop more effective therapies of AMD. AIM: This article will focus on the options in the management of neovascular age-related macular degeneration and recent therapeutic options. RESULTS: The recent development of anti-VEGF (vascular endothelial growth factor) substances for use in clinical routine has markedly improved the prognosis of patients with neovascular AMD. Intravitreal treatment with substances targeting all isotypes of Vascular Endothelial Growth Factor (VEGF), for the first time results in a significant increase in visual acuity in patients with neovascular AMD. The combination with occlusive therapies like photodynamic therapy (PDT) potentially offers a reduction of re-treatment frequency and long-term maintenance of the treatment benefit. Further developments interacting with various steps in the angiogenic cascade are under clinical or preclinical evaluation and may soon become available. CONCLUSION: Nevertheless, the growing number of novel therapeutic options will have to provide proof of concept in randomized controlled clinical trials.