FDA Urges Avoidance of 2 OTC Dry Eye Disease Treatments
At press time, the FDA is urging consumers and clinicians to steer clear of Global Pharma’s OTC dry eye disease treatments EzriCare Artificial tears, and Delsam Pharma’s Artificial Eye ointment. The reason: a likelihood of drug-resistant Pseudomonas aeruginosa contamination, which has caused permanent vision loss, and 1 death.
Global Pharma initiated a voluntary recall of all unexpired lots of these treatments. To report any adverse events related to these treatments, the FDA suggests accessing the MedWatch Reporting Program at bit.ly/3INNfFh .
Ocuphire New Drug Applcation for Mydriasis Drug Accepted by FDA
Ocuphire Pharma, Inc. announced the FDA acceptance of the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically induced mydriasis. The FDA assigned a Prescription Drug User Fee Act date of September 28, 2023. The NDA filing is supported by positive results from the comprehensive MIRA clinical program, involving over 600 subjects, including the MIRA-1 phase 2b trial, MIRA-2, and MIRA-3 phase 3 pivotal trials, and MIRA-4 phase 3 pediatric trial.
Orasis Annnounces FDA Acceptance to Review New Drug Application for Presbyopia Drug
Orasis Pharmaceuticals announced that the FDA has accepted for review the company’s NDA for its investigational CSF-1 (low-dose pilocarpine hydrochloride 0.4%) for the treatment of presbyopia. The FDA assigned a Prescription Drug User Fee Act goal date of October 22, 2023. The NDA is based on data from the phase 3 NEAR-1 and NEAR-2 clinical trials, which evaluated the efficacy and safety of CSF-1.
Ophthalmologist in Viral Video Encourages Pro Bono Cataract Surgery
Jeffrey H. Levenson, MD, who participated in the viral MrBeast YouTube video “1,000 Blind People See for the First Time” (See bit.ly/3XWSI0T ), recommends his colleagues consider pro bono cataract surgery.
“Cataract surgery is an ideal charitable activity for ophthalmologists because it requires a one-time intervention that, pretty much always works, doesn’t require a long-term commitment to follow-up, isn’t costly, and results in grateful patients,” he explains.*
* For a longer version of this news item, which includes tips on how to get involved in pro bono cataract surgery, visit the news section of www.cornealphysician.com .