The FDA approved pilocarpine hydrochloride ophthalmic solution (Qlosi) for adults with presbyopia, according to a statement from Orasis Pharmaceuticals.
The approval allows for daily or as-needed use, up to twice a day. Orasis officials expect the therapy to be available in the first half of 2024.
“Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs,” said Paul Karpecki, OD, of the University of Pikeville, Kentucky College of Optometry, in the company announcement. “In clinical trials, Qlosi demonstrated the optimal balance of efficacy, safety, and tolerability, and the FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses.”
Support for the approval came from the phase III placebo-controlled NEAR-1 and NEAR-2 clinical trials involving more than 600 patients. The trials met the primary endpoint of at least a three-line gain in distance-corrected near visual acuity with no loss of one line or more in distance visual acuity. The most common treatment-related adverse events (TRAEs) were headache and instillation-site pain, which occurred in 6.8% and 5.8% of study participants, respectively. Among patients randomized to active treatment, 1.3% reported moderate TRAEs; all other AEs were mild.
“Each presbyopia patient has different visual demands; yet, all are impacted in their ability to perform day-to-day functions,” said Richard Lindstrom, MD, of Minnesota Eye Consultants in Minneapolis. “It’s very exciting to see a novel new treatment category emerging for this challenging patient population, which will give eye care professionals more options throughout the presbyopic journey.”