HealthDay News — There is an adverse association between calcium channel blocker (CCB) use and glaucoma, according to a study published online September 7 in JAMA Ophthalmology.

Alan Kastner, MD, from Moorfields Eye Hospital National Health Service Foundation Trust and University College London, and colleagues examined the association between systemic CCB use and glaucoma and related traits in a population-based cross-sectional study involving UK Biobank participants with complete data for analysis of glaucoma status, intraocular pressure (IOP), and optical coherence tomography-derived inner retinal layer thicknesses. Data were included for 427,480 adults (median age, 58 years), including 33,175 CCB users (7.8%).

The researchers found that use of CCBs, but not other antihypertensive agents, was associated with increased odds of glaucoma after adjustment for key sociodemographic, medical, anthropometric, and lifestyle factors (odds ratio, 1.39). CCB use was also associated with thinner macular ganglion cell-inner plexiform layer and macular retinal nerve fiber layer thickness (−0.34 and −0.16 µm, respectively), but not with IOP.

“This cross-sectional study adds further support to an adverse association between CCB use and glaucoma, despite no apparent association with IOP,” the authors write. “This warrants further investigation to determine whether the associations are causal and to probe potential underlying biological mechanisms.”

Several authors disclosed ties to the pharmaceutical industry.

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Andy S. Huang, MD, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a comparative cross-sectional study recruiting 15 participants aged 31 to 67 years, including 12 attending physicians and 3 senior trainees, to compare the diagnostic accuracy and comprehensiveness of responses from an LLM chatbot with those of fellowship-trained glaucoma and retina specialists. Responses were assessed via a Likert scale for glaucoma and retina questions (10 of each type) in deidentified glaucoma and retina cases (10 of each type).

The researchers found that the combined question-case mean rank for accuracy was 506.2 and 403.4 for the LLM chatbot and glaucoma specialists, respectively; the corresponding mean ranks for completeness were 528.3 and 398.7. The mean rank for accuracy was 235.3 and 216.1 for the LLM chatbot and retina specialists, respectively; the corresponding mean ranks for completeness were 258.3 and 208.7. A significant difference was seen between all pairwise comparisons, except for specialist vs trainee, in rating chatbot completeness in the Dunn test. Compared with their specialist counterparts, both trainees and specialists rated the chatbot’s accuracy and completeness more favorably, with specialists noting a significant difference in the accuracy and completeness of the chatbot.

“These findings support the possibility that artificial intelligence tools could play a pivotal role as both diagnostic and therapeutic adjuncts,” the authors write.

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Travoprost, a prostaglandin analog, is a selective FP prostanoid receptor agonist that is believed to reduce IOP by increasing uveoscleral outflow. iDose TR is a sterile intracameral implant containing 75mcg of travoprost. It is designed to continuously deliver the drug inside the eye for extended periods of time.

The safety and efficacy of iDose TR was based on 2 randomized, parallel-group, double-masked, controlled phase 3 trials (ClinicalTrials.gov Identifier: GC-010 [NCT03519386], GC–012 [NCT03868124]) in adult patients with open-angle glaucoma or ocular hypertension. Study participants were randomly assigned to receive either iDose TR containing travoprost 75mcg with different release rates or timolol maleate ophthalmic solution 0.5% twice daily. The primary endpoint for both studies was the change from baseline in diurnal IOP (as measured at 8am and 10am) over 3 months (day 10, week 6, and month 3).

Findings showed that treatment with iDose TR demonstrated an IOP reduction of 6.6 to 8.4mmHg over the first 3 months compared with an IOP reduction of 6.5 to 7.7mmHg in the timolol arm. iDose TR was found to be noninferior to timolol in IOP reduction over the first 3 months, but did not demonstrate noninferiority over the following 9 months. Across both trials, 81% of patients who received iDose TR were completely free of IOP-lowering topical medications.

The most common ocular adverse reactions reported with iDose TR were increased IOP, iritis, dry eye, and visual field defects. The prescribing information for iDose TR includes warnings and precautions associated with iridocorneal angles, device dislocation, macular edema, intraocular inflammation, pigmentation, and endophthalmitis. The product is contraindicated in patients with active or suspected ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation or endothelial cell transplants.

iDose TR is pre-loaded in a sterile, single-dose inserter. Treatment is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle. iDose TR should not be readministered to an eye that received a prior iDose TR.

The product is expected to be available in the first quarter of 2024.

Apotex Corp has announced the voluntary recall of 6 lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% due to cracks found in the unit caps of the solution bottles.

Brimonidine Tartrate Ophthalmic Solution, an alpha-adrenergic receptor agonist, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The recalled lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% were distributed nationwide between April 5, 2022 and February 22, 2023. According to the Company, the broken caps may affect the sterility of the product and lead to possible adverse events.

The following Brimonidine Tartrate Ophthalmic Solution, 0.15% products are being recalled out of an abundance of caution:

• Pack size 5mL; NDC # 60505-0564-1; Lot # TJ9848 and TJ9849; Expiration Date 02/2024.
• Pack size 5mL; NDC # 60505-0564-1; Lot # TK0258 and TK5341; Expiration Date 04/2024.
• Pack size 10mL; NDC # 60505-0564-2; Lot # TK0261; Expiration Date 04/2024.
• Pack size 15mL; NDC # 60505-0564-3; Lot # TK0262; Expiration Date 04/2024.

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

Reference

Apotex Corp. issues voluntary nationwide recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% due to cracks that have developed in some of the units caps of the bottles. News release. Apotex Corp. March 1, 2023. Accessed March 2, 2023. https://prnmedia.prnewswire.com/news-releases/apotex-corp-issues-voluntary-nationwide-recall-of-brimonidine-tartrate-ophthalmic-solution-0-15-due-to-cracks-that-have-developed-in-some-of-the-units-caps-of-the-bottles-883134720.html.

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