Onidra - Phenylephrine / Ketorolac

What is Onidra - Phenylephrine / Ketorolac used for?

Omidria is a medicine used in adults for intraocular lens implantation interventions for maintaining mydriasis (pupil dilation) and preventing miosis (pupil contraction), as well as for alleviating eye pain after surgery. Contains the active ingredients phenylephrine and ketorolac

How is Onidra - Phenylephrine / Ketorolac used?

Omidria is available as a solution concentrate for intraocular irrigation (a solution used to rinse the inside of the eye during surgery). The medicine can only be obtained with a prescription and must be administered by a surgeon who specializes in ophthalmology (ophthalmology) who is an expert in intraocular lens implantation procedures. A new lens is implanted in this type of procedure. The crystalline lens is the part of the eye which, by focusing on the retina the light rays passing through the pupil, allows for a clear vision.

The recommended dose is 4 ml of Omidria diluted in 500 ml of irrigation solution, administered during an intraocular lens implant operation. The ophthalmologist can also prescribe eye drops usually used before and after surgery, in order to prevent eye infections and pain.

How does Onidra - Phenylephrine / Ketorolac work?

Omidria contains the active substances phenylephrine and ketorolac. Phenylephrine is a "selective alpha-1 adrenergic receptor agonist", which binds, activating them, to alpha-1 adrenergic receptors present on smooth muscle cells, stimulating muscle contraction. When applied to the eye, felinephrine induces the contraction of the iris muscle, allowing the pupil to dilate. This facilitates the intervention of intraocular lens implantation.

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances involved in pain and inflammatory processes. Applied to the eye, ketorolac reduces the production of prostaglandins locally, thereby alleviating the pain and inflammation caused by surgery.

Both active substances have been available in the European Union (EU) for several years as separate preparations

What benefit has Onidra - Phenylephrine / Ketorolac shown during the studies?

Omidria was examined in two main studies, involving a total of 821 patients who underwent intraocular lens implantation surgery, in which Omidria was compared with a placebo (a dummy treatment). In both studies, the main parameters of effectiveness were the change in the pupillary diameter at the end of the operation and the intensity of pain perceived by the patients immediately after the operation, based on a standard pain scale ranging from 1 to 100.

The two studies showed that in patients treated with Omidria the pupil remained dilated during surgery (+0.1 mm), while in subjects treated with placebo it contracted (-0.5 mm). Less than 1 in 10 patients treated with Omidria had a pupillary diameter of less than 6 mm (a value that makes surgery difficult), a figure that, on the contrary, was recorded in about 4 patients out of 10 treated with placebo. As for pain, patients treated with Omidria reported an average pain score of about 4 compared to the score of about 9 given by placebo-treated subjects. Furthermore, 7% (29 out of 403) of patients treated with Omidria reported moderate to severe pain compared to 14% (57 out of 403) of placebo-treated patients, while 25% (104 of 403) complained of no pain in the period immediately following the intervention compared to 17% (69 of 403) of patients treated with placebo.

What is the risk associated with Onidra - Phenylephrine / Ketorolac?

The most common side effects of Omidria (which may affect more than 1 in 10 people) are eye pain, inflammation of the anterior chamber (inflammation of the inner space filled by the aqueous humor, between the iris and the cornea), hyperemia conjunctival (redness of the membrane that covers the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal edema (swelling of the transparent membrane covering the pupil and iris) and inflammation. These side effects are typical of postoperative interventions for intraocular lens implants, they are mostly mild to moderate and resolve spontaneously. The incidence of undesirable effects with Omidria was similar to that reported in patients treated with placebo. For the full list of all side effects reported with Omidria, see the package leaflet.

Omidria should not be used in patients with narrow-angle glaucoma, a serious eye condition in which the pressure inside the eye increases rapidly because the aqueous humor cannot flow. For the full list of limitations, see the package leaflet.

Why has Onidra - Phenylephrine / Ketorolac been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Omidria's benefits are greater than its risks and recommended that it be approved for use in the EU. Omidria has been shown to be effective in maintaining dilation and preventing pupil contraction in intraocular lens implantation procedures, which should help make surgery easier and safer. The efficacy of Omidria on pain, although modest, was considered clinically significant. Regarding the safety of Omidria, the medicine was generally well tolerated.

What measures are being taken to ensure the safe and effective use of Onidra - Phenylephrine / Ketorolac?

A risk management plan has been developed to ensure that Omidria is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Omidria, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information is available in the summary of the risk management plan.