Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2).

PURPOSE: To evaluate the safety and efficacy of lotilaner ophthalmic solution 0.25% compared with vehicle for the treatment of Demodex blepharitis. DESIGN: Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial. PARTICIPANTS: Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group). METHODS: Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash. MAIN OUTCOME MEASURES: Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events. RESULTS: At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable. CONCLUSIONS: Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Posterior Vitreous Detachment and Risk of Neovascular Glaucoma in Eyes with Prior Retinal Vascular Occlusions.

INTRODUCTION: To investigate the impact of posterior vitreous detachment (PVD) on the risk of developing neovascular glaucoma (NVG) in eyes with occlusions of the retinal artery (RAO) or retinal vein (RVO). METHODS: Single-center retrospective case-control study of adults with a history of RVO/RAO. Cases (N = 101) who developed NVG were age and sex matched 1:2 to controls who did not develop NVG (N = 202). Multivariable logistic regression was used to estimate the association between history of PVD and risk of NVG while controlling for other related demographic or clinical factors. RESULTS: In initial bivariate analyses, there was no difference in risk of NVG based on eye, lens status, hypertension, history of panretinal photocoagulation (PRP), or retinal surgery (all p > 0.10), a borderline difference based on diabetic retinopathy (DR) (p = 0.06) and prior anti-vascular endothelial growth factor (anti-VEGF) treatment (p = 0.08), and a significant difference based on race/ethnicity, type of vascular event, and PVD status (all p < 0.05). In the final multivariable model, patients without PVD were significantly more likely to develop NVG (OR = 3.07, p = 0.0001) independent of the other covariates. Risk of NVG was greater in those with DR (OR = 1.98, p = 0.0440) and in those with central RVO vs. branch RVO/hemiretinal RVO (OR = 5.77, p < 0.0001). Non-White/Non-Hispanics (OR = 2.56, p = 0.0051) and Hispanics (OR = 3.65, p = 0.0288) were more likely than White patients to develop NVG. CONCLUSIONS: Progression to NVG after retinal vascular occlusion is more likely in Non-White/Hispanic patients, those with concomitant DR, and those with CRVO/CRAO. The absence of PVD increases the risk for NVG. Further studies are necessary to understand this relationship.

The Ocular Trauma Score Underestimates Visual Recovery for the Most Severe Open-Globe Injuries.

PURPOSE: To compare visual outcomes after open-globe injury (OGI) with those predicted by the Ocular Trauma Score (OTS), and to investigate the effect of treatment with pars plana vitrectomy (PPV). DESIGN: Retrospective cohort study. SUBJECTS: Patients presenting with OGI to an academic United States ophthalmology department from 2017 to 2020. METHODS: Best-corrected visual acuity (VA) measurements at the most recent follow-up were compared with final VA predicted by the OTS, based on preoperative injury characteristics. The most recently measured VA of patients treated with PPV during initial OGI repair (primary PPV group) was compared with patients treated with PPV after initial OGI repair (secondary PPV group) and patients never treated with PPV (No PPV group). MAIN OUTCOME MEASURES: Best-corrected VA in the injured eye at last follow-up; secondary outcome measures included the occurrence of vitreous hemorrhage at any time, occurrence of retinal detachment at any time, rates of additional surgery, and rates of enucleation. RESULTS: One-hundred and thirty-three subjects with OGI were identified and analyzed. The overall rate of PPV was 32%. Predictors of worse VA at last follow-up included older age (P = 0.047) and worse presenting VA (P < 0.001). Visual acuity outcomes for eyes in OTS categories 2 to 5 did not significantly differ from OTS predictions. However, eyes in OTS category 1 had a higher likelihood of last follow-up VA of light perception (LP) to hand motion (46% in the study cohort vs. 15% predicted by the OTS, P = 0.004) and a lower likelihood of no LP (33% vs. 74%, P < 0.001). The secondary PPV group had the worst VA at presentation among the 3 groups (P = 0.016), but VA at last follow-up did not significantly differ between the study groups (P = 0.338). CONCLUSIONS: The most severe OGIs (i.e., OTS category 1) had better visual outcomes than predicted by the published OTS expectations, and secondary PPV was associated with significant visual improvement despite poor prognostic predictions. Evaluation by a vitreoretinal surgeon should be considered for all patients with severe OGI, especially those in OTS category 1. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Bisphosphonate-associated orbital inflammation--a case report and review.

Bisphosphonates are becoming more widespread as indications for them broaden. Several ocular side effects due to bisphosphonates have been described, among the most potentially serious of which is orbital inflammation. Thirteen case reports of this side effect exist in the literature, with an additional case reported here. The most common presenting signs are lid edema, conjunctival hyperemia, and chemosis, while common symptomatology includes pain, diplopia, and blurry vision. A concomitant anterior uveitis is present in 30% of cases, and some degree of bilaterality is also seen in 30% of cases. There are two reported instances of profound visual loss, highlighting the importance of prompt recognition and treatment of this entity. Despite a paucity of rechallenge data, available reports suggest that development of orbital inflammation does not necessarily exclude patients from future bisphosphonate use.

But it's not all there.

A 44-year-old man presented with acute onset headache and isolated anisocoria. Dilation lag was noted in the smaller pupil and Horner syndrome was suspected despite the lack of eyelid ptosis. Cocaine testing confirmed the clinical diagnosis, and urgent neuroimaging found an internal carotid artery dissection. The patient was managed with systemic anticoagulation with a good final outcome. Horner syndrome should be suspected in any patient with aniscoria and dilation lag, despite the absence of eyelid ptosis or other associated findings.