The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in the US that specifically targets tear evaporation caused by meibomian gland dysfunction. An ophthalmic solution with a similar name, Meibo Tears (Vista), which contains 0.6% propylene glycol, is available over the counter for dry eye relief.

The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).

Sodium hyaluronate (Hyalgan - Sanofi) and hylan G-F 20 (Synvisc - Wyeth- Ayerst) have been approved by the FDA for intra-articular injections in patients with knee pain due to osteoarthritis. Hylan G-F 20 is a cross-linked derivative of hyaluronic acid with a higher molecular weight than sodium hyaluronate. 'Hyaluronan' refers to either the acid or its salt.

The FDA has approved a single-injection hyaluronic acid gel (Durolane – Bioventus) and an extended-release (ER) formulation of the synthetic corticosteroid triamcinolone acetonide (Zilretta – Flexion) for intra-articular (IA) treatment of osteoarthritic knee pain.

Bellafill (Suneva), a dermal filler approved earlier for correction of nasolabial folds, has now also been approved by the FDA for correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in adults ≥21 years old. It is the only dermal filler approved in the US for correction of facial acne scars.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

The FDA has approved the ReShape Integrated Dual Balloon System (ReShape Medical) and the Orbera Intragastric Balloon System (Apollo Endosurgery) for up to 6 months of use in adults with a BMI of 30-40 who have not been able to maintain weight loss with a weight loss program and, for ReShape, who have at least one obesity-related comorbidity. Both devices have been available in the European Union and elsewhere for years (20 years for Orbera). Three other devices, the LAP-Band, the Realize adjustable gastric band, and the Maestro Rechargeable System, are FDA-approved for long-term...

The FDA has approved Sinuva (Intersect ENT), a sinus implant that gradually releases the corticosteroid mometasone furoate over a 90-day period, for treatment of nasal polyps in adults who have had ethmoid sinus surgery. Propel, a sinus implant that releases mometasone furoate over 30 days, is FDA-approved to maintain the sinus opening after ethmoid sinus surgery; it is marketed by the same manufacturer as Sinuva.

Pressure is the most critical factor in the development of pressure ulcers; high pressure applied constantly for two hours produces irreversible tissue ischemia and necrosis. Malnutrition, fecal and urinary incontinence, fractures, and a low serum albumin may be additional risk factors. Frequent turning and mobilization of patients, relieving pressure and allowing tissue reoxygenation, are the most effective means of prevention and treatment (PS Goode and RM Allman, Med Clin North Am, 73:1511, Nov 1989).