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From: Lenz Therapeutics
The FDA approved aceclidine ophthalmic solution 1.44% for treating presbyopia in adult patients, marking the first and only FDA approved aceclidine-based eye drop for this condition. Vizz is a predominantly pupil-selective miotic that contracts the iris’ sphincter muscle, creating a pinhole effect to significantly improve near vision without causing a myopic shift. In phase 3 trials, Vizz demonstrated its ability to improve near vision within 30 minutes, lasting up to 10 hours. The eye drop was well tolerated, with the most common adverse events being mild, transient, and self-resolving installation site irritation, dim vision, and headache. This approval is considered a transformative advancement, offering a new potential standard of care for presbyopia.
For more information: lenz-tx.com
From: Teva Pharmaceuticals
The FDA approved fremanezumab-vfrm for the preventive treatment of episodic migraine in children and adolescents aged 6 to 17 years who weigh 45 kg or more. This marks the first and only calcitonin gene-related peptide antagonist indicated for preventive treatment of episodic migraine in pediatric patients, expanding on its initial 2018 FDA approval for adults. The expanded indication is supported by data from the SPACE trial (NCT04458857), a phase 3 study that showed that fremanezumab significantly reduced monthly migraine days compared with placebo (–2.5 vs –1.4; P= .0210), with effects noticeable as early as 1 month.
For more information: tevapharm.com
From: Camber Pharmaceuticals
Compare with: Motegrity (Takeda Pharmaceuticals)
Camber Pharmaceuticals added prucalopride tablets to its portfolio, marking a new generic for Motegrity. These tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. CIC is a prevalent condition affecting approximately 10% to 17% of the global population, with a higher incidence in women and older adults. Prucalopride tablets are available in 1- and 2-mg strengths and are packaged in 30-count bottles.
For more information: camberpharma.com
From: Audien Hearing
Audien Hearing has launched its flagship products, the Atom One and Atom Pro 2 hearing aids, at Walgreens stores and online at walgreens.com. This rollout signifies Audien’s entry into retail pharmacy and represents a broader shift toward omnichannel distribution to address the global challenge of hearing loss, which affects more than 1 billion people. Audien products were expected to be available in nearly 2000 Walgreens stores in August, expanding to more than 4400 stores by mid-November. The discreet hearing solutions, starting at $98, offer hearing care without prescriptions, appointments, or high costs.
For more information: audienhearing.com
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