Eye Drops For Presbyopia Win US FDA Approval

Florida: The FDA approved pilocarpine hydrochloride ophthalmic solution (QLOSI™) for adults with presbyopia, according to a statementopens in a new tab or window 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-2opens in a new tab or window 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.”

Related Posts

  • Pharma
  • June 21, 2024
  • 57 views
Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of May, has revealed that the carbapenem antibiotic Meropenem is linked with adverse drug…

  • Pharma
  • June 21, 2024
  • 67 views
Plan To Regulate Nutraceutical Industry Underway

NEW DELHI: India’s foods regulator is working on a draft regulation to clearly demarcate nutraceuticals and pharmaceutical drugs, to eliminate ambiguity and ensure that health supplements that are borderline pharma…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

Plan To Regulate Nutraceutical Industry Underway

Plan To Regulate Nutraceutical Industry Underway

Ayush And Herbal Products Exports Grow Over 20% In April

Ayush And Herbal Products Exports Grow Over 20% In April

NMC Says No Antibiotics Before Diagnostic Tests

NMC Says No Antibiotics Before Diagnostic Tests

Health, Drug Control Officials To Monitor Sale Of Abortion Kits

Health, Drug Control Officials To Monitor Sale Of Abortion Kits

Punjab: 11-Month-Old Given Expired Vaccine At Amritsar’s Private Hospital

Punjab: 11-Month-Old Given Expired Vaccine At Amritsar’s Private Hospital