Latest news with #eyedrops
Medscape
20-05-2025
- Health
- Medscape
Study: Dropless Cataract Surgery Slashes Drug Costs
A regimen that spares patients recovering from cataract surgery the burden of using antibacterial and anti-inflammatory eye drops several times a day for weeks and instead uses an injection to administer those drugs immediately after the procedure is nearly as effective at preventing complications as the traditional drop regimen at a fraction of the cost, a study of both approaches found. 'Our study aims to underscore the benefits of the dropless cataract surgery approach as a promising alternative to the traditional drop regimen, particularly for populations where adherence to postoperative drops is challenging,' Yousef Yousef, a medical student at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, told Medscape Medical News. 'We hope our findings will encourage broader adoption of the dropless protocol by cataract surgeons, potentially establishing it as a new standard of care.' Yousef Yousef Yousef presented results from a retrospective chart review of 544 eyes that had cataract surgery at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting in Salt Lake City. Dropless vs Traditional Protocol The traditional protocol, used in 265 study eyes, consisted of giving patients a prescription for drops of the anti-inflammatory corticosteroid prednisolone 1%, the antibiotic moxifloxacin 0.5%, and the nonsteroidal anti-inflammatory ketorolac 0.5% four times a day with a 4-week taper. The dropless protocol, assigned to 279 eyes, consisted of an intracameral injection of 0.2 mL of moxifloxacin 0.5% and a 10 mg/mL subconjunctival injection of the glucocorticoid triamcinolone (Kenalog) on completion of the operation. The researchers found no significant differences in best-corrected visual acuity. Patients who had the dropless protocol had a higher incidence of cystoid macular edema — 5% vs 1% — Yousef said, but the incidence of ocular hypertension was not statistically significant between the two groups (2% vs 1%). A multivariate regression analysis showed the dropless protocol was not associated with increased risks for either complication, he added. The dropless protocol has three key potential advantages over the traditional approach, Yousef said: Convenience for patients, improved drug bioavailability, and lower cost. 'The traditional drop protocol requires patients to administer three different medications four times daily over a 4-week tapering period,' he told Medscape Medical News . 'This regimen results in a total of 12 drops per day for one eye and 210 drops over the course of the taper.' Poor drug bioavailability is a 'significant concern' with topical drops, Yousef said, because the epithelial membrane of the cornea can limit the ability of the drops from penetrating into the eye. 'Intracameral injection bypasses these barriers, delivering a more direct treatment,' he said. A 2020 analysis of Medicare claims reported the average cost of medications for eye drops after cataract surgery was $228 per eye. 'Notably, 76.5% of this total cost was attributed to the use of brand-name medications,' Yousef said. 'In contrast, the dropless approach costs just $15.91 per eye when a single vial is used for approximately 10 cases.' The new data are important because few randomized clinical trials have compared the dropless and traditional protocols for treating pain and inflammation and preventing infections after cataract surgery, according to Neal Shorstein, MD, a retired cataract surgeon with Kaiser Permanente in Northern California . Neal Shorstein, MD 'There are an accumulating number of observational studies, so this adds to the retrospective, observational literature, and that's a good thing because different locations and practice environments add to the experience,' said Shorstein, an adviser to the Seva Foundation, a nonprofit group that develops eye care programs in underserved regions. The doses of medication used in the dropless protocol in the analysis are higher than what others have reported. The 0.2 mL of intracameral moxifloxacin 0.5% is 'about the upper limits of what you want to inject of moxifloxacin.' The 0.5-mL dose of subconjunctival triamcinolone is, 'in my estimation, a good dose.' The formulation of triamcinolone used has a large particle size, which 'matters a lot because the safety and effectiveness of triamcinolone depends on the particle size,' he said. Triesence, another formulation of triamcinolone used in some dropless protocols, has a smaller particle size, he said. The entry point on the conjunctiva for the triamcinolone injection is another important factor, Shorstein added. 'Our findings show that 6-8 mm from the limbus is the optimal location,' he said. The study was independently supported. Yousef and Shorstein reported having no relevant financial relationships.
Fast Company
12-05-2025
- Business
- Fast Company
Eye drop recall: Nearly 76,000 cases of eye care products are feared to be of ‘unacceptable quality'
If you're a frequent eye drop user, now's the time to check your medicine cabinet: The pharmaceutical lab BRS Analytical Service, LLC has issued a voluntary recall of five different ophthalmic solutions, including some eye drops and artificial tears, due to concerns that the products may be of 'unacceptable quality.' Here's what to know: What is the reason for the recall? According to a notice published by the distributor AvKare, the recall was initiated when a U.S. Food and Drug Administration (FDA) audit found 'manufacturing cGMP deviations' in the production of the five eye products. CGMP, or Current Good Manufacturing Practice, refers to the required manufacturing process guidelines set by the FDA for a certain item. Per the AvKare notice, 'Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.' Separately, an FDA enforcement report surrounding the five products notes that there was a 'lack of assurance of sterility' found during the agency's audit. BRS Analytical Service voluntarily initiated the five recalls on April 23. On May 6, the FDA classified each as a Class II, meaning it is considered a situation in which exposure to the product may cause 'reversible adverse health consequences,' or where the probability of serious health consequences is 'remote.' Which products are being recalled? The recall encompasses five products, totaling over 75,000 cases of ophthalmic solution, shipped over a two-year period: May 26, 2023, to April 21, 2025. The products include: NDC# 50268-043-15 Artificial Tears Ophthalmic Solution; recall number D-0404-2025 NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%; recall number D-0405-2025 NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution; recall number D-0406-2025 NDC# 50268-126-15 Lubricant Eye Drops Solution; recall number D-0407-2025 NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution; recall number D-0408-2025 Detailed lots numbers and specific expiration dates can be found here. Where were the products sold? According to the FDA, the items were distributed nationwide in the U.S., though specific states and stores were not listed. What should I do if I have one of the recalled products? If you have a recalled eye solution, do not use it. Instead, AvKare requests that you follow the instructions listed in its notice to alert the company that you received the recalled product, and then ship the affected items back to its headquarters.
Daily Mail
08-05-2025
- Health
- Daily Mail
Urgent nationwide recall for 1.8m eye drops that could make you go BLIND
More than 1.8 million cartons of eye drops have been recalled nationwide due to manufacturing issues that may have made the products unsterile. Recall notices from the distributor, AvKARE, and the Food and Drug Administration (FDA) did not specify what the issue was, or the health hazards of using these eye drops. But they state that improper manufacturing resulted in a 'lack of assurance of sterility' and 'may lead to products of unacceptable quality.' 'It is not possible to rule out patient risks resulting from use of these products,' the AvKARE notice states. Using eye drops that are not properly sterilized can lead to serious eye infections, potentially causing temporary vision loss or even blindness. In 2023, the CDC linked 50 infections across 11 states to eyedrops that were contaminated with an antibiotic-resistant bacteria. One patient died and several were left permanently blind. Products subject to the recall include: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution and Polyvinyl Alcohol Ophthalmic Solution. The faulty drops were distributed between May 26, 2023 and April 21, 2025, and all of them appear to be for alleviating dry eye symptoms. The FDA discovered the manufacturing issues during an audit. Their notice does not state who manufactured the drops or if they were made by a particular brand. AvKARE, a healthcare distributor for pharmaceuticals and infection control products based in Pulaski, Tennessee, urged consumers who purchased the potentially contaminated drops to stop using them immediately. It also stated that stores which purchased the drops should remove them from their inventory and return them to AvKARE for a full refund, which will also cover the cost of shipping them back to the distributor. 'We regret any inconvenience that this may cause,' the notice states. It also explains that BRS Analytical Service, LLC. notified AvKARE of the voluntary recall. BRS Analytical Service is an independent contract testing laboratory that tests pharmaceutical products to make sure they are properly manufactured and ready for distribution. The recalled eye drops were intended to treat dry eye, which is a condition that occurs when the eyes either don't produce enough tears to keep the eye moist, or the tears they produce don't work properly. Symptoms include irritation that feels like a gritty or sandy sensation in the eyes, stinking or burning; redness; sensitivity to light; stringy mucus in or around the eyes; blurred vision and tired eyes. This recall comes at a time when more people may be using eye drops, as allergy season can make dry eye symptoms worse. Using eye drops that are not properly sterilized can lead to serious eye infections, potentially causing temporary vision loss or even blindness Allergic reactions to pollen cause inflammation in the eyes, which can reduce tear production. Allergy medications such as antihistamines or decongestants can contribute to dry eye symptoms too. As a result, eyedrop sales tend to increase in the spring, when the pollen count is high. This is a Class II recall, which means use of or exposure to these drops may cause temporary or reversible health issues, but the likelihood of serious health consequences is low, according to the FDA. At this time, it does not appear that any consumers have reported health issues related to the use of these eye drops.
