Glycemic Trends in Patients with Thyroid Eye Disease Treated with Teprotumumab in 3 Clinical Trials.

PURPOSE: Assess incidence, severity, and glucose excursion outcomes in thyroid eye disease (TED) patients receiving the insulin-like growth factor-1 receptor inhibitor teprotumumab from 3 clinical trials. DESIGN: Analysis of pooled glycemic data over time. PARTICIPANTS: Eighty-four teprotumumab- and 86 placebo-treated active TED patients from the phase 2 and phase 3 (OPTIC) controlled clinical trials and 51 teprotumumab-treated patients from the OPTIC extension (OPTIC-X) trial. METHODS: Eight intravenous infusions were given over 21 weeks. Phase 2 serum glucose was measured at weeks 1, 4, 15, and 21, with fasting measurements at weeks 1 and 4. Serum glucose was measured at each study visit in OPTIC and OPTIC-X, with fasting measurements at weeks 1 and 4 (in patients without diabetes) or all visits (in patients with diabetes). In all studies, hemoglobin A1c (HbA1c) was measured at baseline, 12, and 24 weeks plus weeks 36 and 48 in OPTIC-X. MAIN OUTCOME MEASURES: Serum glucose and HbA1c. RESULTS: In the phase 2 and 3 studies, 9 hyperglycemic episodes occurred in 8 teprotumumab patients; mean HbA1c level increased 0.22% from baseline to week 24 (to 5.8%; range, 5.0%-7.9%) versus 0.04% in patients receiving the placebo (to 5.6%; range, 4.6%-8.1%). At study end, 78% (59/76) of teprotumumab patients and 87% (67/77) of patients receiving placebo had normoglycemic findings. Normoglycemia was maintained in 84% (57/68) of patients receiving teprotumumab and 93% (64/69) of patients receiving placebo. Among baseline prediabetic patients, 43% (3/7) remained prediabetic in both groups, and 29% (2/7) of teprotumumab patients and 14% (1/7) of patients receiving placebo had diabetic findings at week 24. OPTIC-X patients trended toward increased fasting glucose and HbA1c whether initially treated or retreated with teprotumumab. Fasting glucose commonly rose after 2 or 3 infusions and stabilized thereafter. Most hyperglycemic incidents occurred in patients with baseline prediabetes/diabetes but were controlled with medication. No evidence was found for progression or increased incidence of hyperglycemia with subsequent doses. CONCLUSIONS: Serious glycemic excursions are uncommon in patients with normoglycemia before teprotumumab therapy. Patients with controlled diabetes or impaired glucose tolerance can be treated safely if baseline screening, regular monitoring of glycemic control, and timely treatment of hyperglycemia are practiced. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Orbital Fractures.

Anatomic, rather than volumetric, reconstruction leads to improved outcomes in orbital reconstruction. Endoscopic visualization improves lighting and magnification of the surgical site and allows the entire operative team to understand and participate in the procedure. Mirror-image overlay display with navigation-guided surgery allows in situ fine adjustment of the implant contours to match the contralateral uninjured orbit. Precise exophthalmometry is important before, during, and after surgery to provide optimal surgical results.

Echographic evidence of regression of a periocular infantile capillary hemangioma treated with systemic propranolol.

This article documents quantitative changes in the size of a periocular capillary hemangioma using sequential echographic testing in a patient receiving off-label treatment with systemic propranolol therapy. The patient presented at 7 weeks old with a right periocular capillary hemangioma. Systemic propranolol therapy was elected. Diagnostic B-scan and quantitative A-scan echography documented the lesion size at presentation as 22.3 mm in greatest dimension. The tumor decreased in size to 20.0 mm after 2½ weeks of treatment and 16.0 mm after 6½ weeks of treatment. No adverse side effects have been noted. Echography is an excellent modality for documenting the regression of periocular capillary hemangiomas during treatment with systemic propranolol.

Characteristics of optic nerve head drusen on optical coherence tomography images.

BACKGROUND AND OBJECTIVE: To describe the characteristics of optic nerve head drusen in optical coherence tomography (OCT) images. PATIENTS AND METHODS: Cross-sectional images of the optic nerve were obtained in seven patients with optic nerve head drusen with Stratus and spectral-domain OCT (Carl Zeiss Meditec, Dublin, CA). These were compared to optic disc photographs, autofluorescence, and echography images. For comparison, these tests were performed on four patients with papilledema and three patients with small optic discs. RESULTS: Optic nerve head drusen typically elevated the disc surface and appeared as an optically empty cavity, sometimes with a perceptible reflection from the posterior surface. The disc surface was also elevated in cases of papilledema, but had a strong anterior reflectance behind which there was no visible structure. The surface of the small optic nerves was slightly elevated, but with less anterior reflectance. CONCLUSION: Optic nerves with drusen showed features in these OCT images that were distinct from cases of papilledema or small optic discs.

Eyelash growth from application of bimatoprost in gel suspension to the base of the eyelashes.

OBJECTIVE: To determine whether bimatoprost (Lumigan, Allergan Inc., Irvine, CA) causes increased lash length when used in gel suspension applied to the base of the eyelashes. DESIGN: Randomized controlled trial. PARTICIPANTS: Nineteen subjects were enrolled. METHODS: Subjects recruited from the Bascom Palmer Eye Institute were screened, and those who met inclusion criteria were enrolled. Each participant received 2 vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with Gonak gel (Akorn Inc., Lake Forest, IL) and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the upper eyelid eyelashes every evening on the designated eye for 6 weeks. MAIN OUTCOME MEASURES: Lash length was measured with a caliper at enrollment, at weekly intervals during the application of the gel, and at 1 and 3 months after discontinuation of its use. Visual acuity, ocular symptoms, intraocular pressure, and photographs were documented at these same intervals. RESULTS: The mean eyelash growth from baseline in the bimatoprost group was 2.0 mm versus a mean of 1.1 mm in the placebo group, which was a statistically significant difference (P=0.009). The average intraocular pressure decreased equally in both groups (2 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. CONCLUSIONS: Our data showed an increase in eyelash length with the use of bimatoprost in gel suspension, suggesting the product's eyelash-lengthening properties.