Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2).

OBJECTIVE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). RESULTS: Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2-7.4, 6.5-7.8, and 6.1-6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. CONCLUSIONS: The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. CLINICALTRIALS. GOV IDENTIFIER: NCT02250651.

Characteristics of Pediatric Glaucoma in a Latin American Reference Center.

AIM: To describe the clinical and epidemiological characteristics of children with pediatric glaucoma (PG) treated in an ophthalmologic national reference center. MATERIALS AND METHODS: A retrospective study of patients diagnosed with PG in a national ophthalmologic reference center was made, between 2005 and 2015. Clinical findings, type of treatment, and the follow-up were evaluated. RESULTS: A total of 89 patients (145 eyes) were included. The median age of diagnosis was 2.0 years. The most frequent type of glaucoma was primary PG with 67.4% of affected patients, primary congenital glaucoma (PCG) being more frequent (69 eyes) than juvenile open-angle glaucoma (JOAG 36 eyes). Secondary PG accounted for 32.6% of the cases (40 eyes). At least one surgical procedure was needed in 56.6% of all studied eyes, and 10.7% of eyes had more than two surgical procedures. Even more, eyes with PCG had surgery in 88.4% of cases. On the contrary, eyes with JOAG did not require surgery. In the last assessment, the distribution of cases according visual acuity did not show differences. However, it is important to note that patients with secondary PG maintained a good vision only in 17.9% of cases. CONCLUSION: Pediatric glaucoma is a heterogeneous group of diseases, and due to its low incidence, descriptive reports of large cohorts are not available. This study has a well-detailed report of PG characteristics in a national reference center. The frequency of JOAG in the present study was significantly higher than that reported in other studies. Also, clinical characteristics of all glaucoma described have some differences from data published. CLINICAL SIGNIFICANCE: There are few studies that describe characteristics of PG. This study is an important tool to analyze the characteristics of PG in an effort to better know the disease. HOW TO CITE THIS ARTICLE: Saavedra C, Rios HA, Belalcazar S, et al. Characteristics of Pediatric Glaucoma in a Latin American Reference Center. J Curr Glaucoma Pract 2020;14(1):10-15.