Timolol Maleate

New Delhi: Drug firm FDC Ltd is recalling over 60,000 bottles of a generic medication, used to treat glaucoma, in the US market due to manufacturing issue, according to the US health regulator. As per the latest Enforcement Report by Food and Drug Administration (USFDA), the Mumbai-headquartered drug firm is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market. The company is recalling the affected lot due to "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle," the USFDA said. The drugmaker initiated the Class II nationwide (US) recall on April 18 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Shares of FDC on Friday ended 0.31 per cent up at Rs 430 apiece on the BSE.

The eyedrop is an option for those who are benefitting from preservative-free eye drops. Credit: Andrey Sayfutdinov/Shutterstock. China’s National Medical Products Administration (NMPA) has approved the marketing authorisation application of Santen Pharmaceutical’s Tapcom to treat individuals with open-angle glaucoma or ocular hypertension. This fixed-combination eye drop comprising tafluprost 0.0015% and timolol 0.5% is designed to lower intraocular pressure (IOP) for individuals with this condition. Glaucoma damages the optic nerve and results in visual field loss. The eye drop offers a therapeutic alternative for individuals whose topical beta-blockers or prostaglandin derivatives monotherapies have not achieved target IOP. It is also an option for those who are benefitting from preservative-free eye drops in prolonged topical usage of glaucoma medication. Tapcom is the country’s first preservative-free ophthalmic combo formulation to include a first-line prostaglandin derivative. Its two active ingredients, tafluprost and timolol maleate, work through different mechanisms to reduce IOP. Tafluprost acid, the active metabolite of tafluprost, is a prostanoid FP receptor agonist that promotes aqueous humour outflow. A nonselective β-receptor inhibitor, timolol maleate, decreases the production of aqueous humour. Tapcom has gained approval in 40 countries and regions, including Asia and Europe. Santen Pharmaceutical chief medical officer Peter Sallstig stated: “Glaucoma remains the leading cause of irreversible blindness worldwide, deeply impacting the quality of life of many patients. “Therefore, Santen has prioritised glaucoma as a key therapeutic focus, dedicating ourselves to the development of treatments that meet patients’ needs and the delivery of high-quality ophthalmic drugs. The approval of Tapcom in China represents a significant milestone, offering new treatment options for Chinese glaucoma patients and advancing the field of glaucoma care.” In November 2024, the company and Arctic Vision signed a commercial partnership agreement for the ARVN001 suprachoroidal injectable suspension for uveitic macular oedema and other ocular conditions.