Tiago Prata

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations. DESIGN: Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study. PARTICIPANTS: Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye, and study eye baseline IOP (hour 0; 8 am) of 22-32 mmHg after washout. METHODS: Study eyes received bimatoprost implant 10 μg (n = 198) or 15 μg (n = 198) on day 1 with readministration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n = 198). Intraocular pressure was measured at hours 0 and 2 at each visit. MAIN OUTCOME MEASURES: Primary end points were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). RESULTS: Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5-17.2, 16.5-17.0, and 17.1-17.5 mmHg through week 12 in the 10-μg implant, 15-μg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol and highest with the 15-μg dose strength. Incidence of corneal TEAEs increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-μg implant) and 21.8% (15-μg implant). Mean best-corrected visual acuity (BCVA) was stable; 3 implant-treated subjects with corneal TEAEs had >2-line BCVA loss at their last visit. CONCLUSIONS: Both dose strengths of bimatoprost implant met the primary end point of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-μg implant over the 15-μg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.

OBJECTIVE: To compare the pattern of intraocular pressure (IOP) reduction following selective laser trabeculoplasty (SLT) versus argon laser trabeculoplasty (ALT) in open-angle glaucoma (OAG) patients, and to investigate the ability of initial IOP reduction to predict mid-term success. METHODS: A prospective, nonrandomized, interventional case series was carried out. Consecutive uncontrolled OAG glaucoma patients underwent SLT or ALT; the same preoperative medical regimen was maintained during follow-up. Data collected included age, type of OAG, pre- and postoperative IOP, number of glaucoma medications, and surgical complications. Post-treatment assessments were scheduled at day 1 and 7 and months 1, 3, and 6. RESULTS: A total of 45 patients (45 eyes) were enrolled [SLT group (n = 25); ALT group (n = 20)]. Groups were similar for age, baseline IOP, and number of glaucoma medications (P ≥ 0.12). We found no significant differences in mean IOP reduction between SLT (5.1 ± 2.5 mmHg; 26.6%) and ALT (4.4 ± 2.8 mmHg; 22.8%) groups at month 6 (P = 0.38). Success rates (IOP ≤ 16 mmHg and IOP reduction ≥25%) at last follow-up visit were similar for SLT (72%) and ALT (65%) groups (P = 0.36). Comparing the pattern of IOP reduction (% of IOP reduction at each visit) between groups, we found a greater effect following SLT compared with ALT at day 7 (23.7% ± 13.7% vs 8.1% ± 9.5%; P < 0.001). No significant differences were observed at other time points (P ≥ 0.32). Additionally, the percentage of IOP reduction at day 7 and at month 6 were significantly correlated in the SLT group (R(2) = 0.36; P < 0.01), but not in the ALT group (P = 0.89). Early postoperative success predicted late success in most SLT cases (82%). No serious complications were observed. CONCLUSION: Although mid-term results suggest SLT and ALT as effective and equivalent alternatives, a greater initial IOP reduction was observed following SLT. In addition, the initial IOP reduction was a good predictor of mid-term success in patients undergoing SLT, but not ALT.

OBJECTIVE: This study evaluated the efficacy and safety of a new device (Eyedrop(®)) designed for eye drop instillation in patients with and without glaucoma. METHODS: This prospective study included consecutive patients with glaucoma and healthy participants. After a complete eye examination and determination of baseline intraocular pressure (IOP), topical hypotensive medication was introduced in both eyes, and the Eyedrop(®) delivery device (a plastic device in which the bottle with eye drops is inserted) was made available to all participants (with video and written instructions) for use in one eye, randomly chosen. In the second phase, all patients were evaluated by an experienced examiner for IOP determination, investigation of possible associated side effects, and ease of instilling eye drops (by a visual analog scale [VAS]; 0-10). RESULTS: Thirty two participants (mean age 42.3±16.2 years) were evaluated. Of these, 44% had glaucoma. There was no significant difference in mean IOP variation when comparing the eye using (-3.9±2.9 mmHg) or not using the device (-3.3±2.6 mmHg; P=0.36). The subjective rating of the facility of drops instillation was significantly higher with the Eyedrop(®) applicator (VAS =7.6±1.6) than without it (VAS =6.2±1.8; P<0.01), with a higher frequency of positive device-related evaluations (VAS score >5) among participants without prior experience with eye drop instillation (78.6% [11/14]) versus those already experienced (66.7% [12/18]). No difference in the frequency of side effects or in the distribution pattern of fluorescein between eyes was observed (P≥0.63). CONCLUSION: Eyedrop(®) received a better subjective response regarding the ease of instillation of hypotensive eye drops compared to traditional instillation, especially in patients with no previous experience with eye drops. Using the device did not result in any loss of hypotensive effect or increase in the frequency of side effects.

BACKGROUND: Several lines of evidence suggest that macular pigment may play a protective role against age-related macular degeneration, but the influence of age on macular pigment density levels remains unclear. This study was designed to investigate the relationship between age and the normal distribution of macular pigment optical density (MPOD) values surrounding the fovea. METHODS: Consecutive healthy subjects with no evidence of ocular disease were enrolled in this study. After inclusion, MPOD values were measured at specific eccentricities (0.5, 1, and 2 degrees) from the foveal center using a dual-wavelength autofluorescence method employing a modified confocal scanning laser ophthalmoscope. Whenever both eyes were eligible, one was randomly selected for analysis. The correlation between age and MPOD values was investigated using regression analysis. RESULTS: Thirty subjects (30 eyes) were included (mean age 48.6 ± 16.4 [range 23-77] years). Significant differences were found between MPOD values measured at 0.5, 1, and 2 degrees from the center of the fovea (0.49 ± 0.12 density units, 0.37 ± 0.11 density units, and 0.13 ± 0.05 density units, respectively, P < 0.05). Significant correlations between age and MPOD values at 0.5 and 1 degree were found (P ≤ 0.02). Values measured at 2 degrees did not correlate significantly with age (P = 0.06). CONCLUSION: In healthy subjects, MPOD values were highest near the foveal center. These values appeared to increase during adulthood (peak at 45-50 years), followed by a gradual reduction after 60 years of age.

PURPOSE: To compare total protein concentration in the aqueous humor of primary open-angle glaucoma and non-glaucomatous patients. METHODS: Aqueous humor samples were obtained from 22 patients just before trabeculectomy for clinically uncontrolled primary open angle glaucoma (POAG group). Aqueous humor (0.1 mL) was aspirated by inserting a 26-gauge needle into the anterior chamber. The same procedure was performed in 22 non-glaucomatous patients just before cataract surgery (control group). Immediately after collection, the aqueous humor was stored at -20 degrees C. Aqueous humor total protein concentration was determined using a colorimetric assay. RESULTS: The geometric mean of total protein concentration of the aqueous humor samples was 32 mg/dL (range: 8-137 mg/dL) in the primary open angle glaucoma group and 16 mg/dL (range: 2-85 mg/dL) in the control group. The ratio of the protein concentration between the two groups was 2.0 (95% confidence interval: 1.3 to 3.2; p=0.003). CONCLUSIONS: The total protein concentration in primary open-angle glaucoma aqueous humor was approximately two times higher than that in non-glaucomatous subjects.