FDA Nod for the Use of Omidria During Cataract Surgery

Cataract SurgeryIn May 2014, the U.S. Food and Drug Administration (FDA) approved the use of Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, a product from Omeros Corporation during cataract surgery or intraocular lens replacement (ILR) in order to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. With this, Omidria became the only FDA-approved product for intraocular use which prevents intraoperative miosis and reduce postoperative pain. This will also improve the efficacy of cataract surgery, which is one of the most common and successful (98% success rate as per CDC 2013 data) surgeries performed in the U.S. Since Medicare covers cataract surgery, ophthalmic surgeons can receive appropriate medical reimbursement by submitting error-free medical claims. To ensure clean claims, they need to maintain accurately transcribed records of cataract procedures.

Omeros claims that Omidria has shown statistically significant and clinically meaningful improvement in preventing miosis and reducing postoperative pain relative to placebo during pivotal trials in which all patients received standard pupil-dilating and anesthetic agents before surgery. Certain healthcare experts also opine thet Omidria is an important advancement in cataract and lens replacement surgery. They gave the following reasons for that.

  • The occurrence of miosis and postoperative pain can make surgical procedures more difficult for surgeons and create an unpleasant postoperative experience for patients. The use of Omidria will allow ophthalmic surgeons to have better control of the operative experience while not changing their surgical routine. This will in turn improve the surgical outcomes.
  • With more restrictive regulations around compounding, ophthalmic surgeons are looking for a safe and effective FDA-approved product that can improve surgical outcomes by maintaining pupil dilation during lens replacement surgery and that quickly resolves postoperatively allowing faster recovery of vision. In this aspect, Omidria is a better solution.
  • The anti-inflammatory ketorolac in Omidria could reduce the requirement of preoperative NSAIDs.

Even so, some health experts point out the risks associated with Omidria such as systemic exposure of phenylephrine can cause elevations in blood pressure and adverse reactions. The most common reactions reported in clinical trials at two to 24 percent were eye irritation, anterior chamber inflammation, posterior capsule opacification and increased intraocular pressure. It is required to dilute Omidria before use; this product is not approved for use in children.

According to the 2013 Centers for Disease Control (CDC) data, 50% of Americans aged 80 years and older have cataracts and 20.5 million Americans aged 40 and older were affected by cataracts. A 2013 study shows there has been a significant increase in cataract surgery for the past 32 years among all age groups except those aged 90 and older. So, we can say that once Omidria is launched, the demand for cataract surgery will increase further due to the improved efficiency. Alongside, there would also be an increased demand among ophthalmologists for the transcription of operative reports.

The Chief Executive Officer of Omeros says that they are working on obtaining European approval for Omidria, securing Medicare pass-through reimbursement and the successful launch of Omridia in the U.S. later this year.