The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

The FDA has approved acoramidis (Attruby – BridgeBio), an oral transthyretin stabilizer, to reduce cardiovascular-related hospitalization and cardiovascular death in adults with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the second transthyretin stabilizer to be approved in the US for this indication; tafamidis (Vyndaqel, Vyndamax) was approved in 2019.

The FDA has approved cefiderocol (Fetroja – Shionogi), a new IV cephalosporin antibiotic, for treatment of complicated urinary tract infections (UTI) caused by susceptible gram-negative bacteria in adults who have limited or no alternative treatment options.

This issue includes reviews of drugs for glaucoma, age-related macular degeneration (AMD), bacterial conjunctivitis, and dry eye disease. Allergic conjunctivitis is reviewed in a separate issue.

In the article on Secondary Prevention of Stroke in the December 8, 2014 issue of The Medical Letter (volume 56, page 125), the duration of treatment with clopidogrel plus aspirin in patients who have had a stroke or TIA should be limited to 21 days, not 90 days. This error, which appears twice, in the paragraphs titled "Clopidogrel Plus Aspirin" and "Conclusion", has been corrected in the article as it appears online.

Oxcarbazepine, which is chemically similar to carbamazepine, and levetiracetam, a pyrrolidine acetamide chemically unrelated to other antiepileptic drugs, are the sixth and seventh drugs approved by the US Food and Drug Administration in the last five years for oral use in partial seizures.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI) available for treatment of depression, has also been approved by the FDA for treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). Duloxetine is one of two drugs approved specifically for management of neuropathic pain due to diabetes; the other, pregabalin (Lyrica - Pfizer), will be marketed soon and will be reviewed in the next issue of The Medical Letter.

The FDA has approved a pegylated form of interferon beta-1a (Plegridy – Biogen) for biweekly treatment of patients with relapsing multiple sclerosis (MS).

The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.

The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and cardiovascular death in adults with either HF (with any left ventricular ejection fraction [LVEF]) or type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risk factors. Sotagliflozin is the first dual SGLT1/2 inhibitor to be approved in the US. Unlike SGLT2 inhibitors, it is not FDA-approved to improve glycemic control in adults with type 2 diabetes....