a) Summary of the safety profile: In clinical studies conducted in Japan, 267 patients were treated with Eybelis for up to 52 weeks.
The most frequently reported adverse reaction was ocular hyperemia including conjunctival hyperemia (22.8%). It was mild in most cases and did not lead to discontinuation of treatment.
b) Tabulated list of adverse reaction: The following adverse reactions have been reported with Eybelis during clinical trials in Japan: (See Table 2.)
Click on icon to see table/diagram/image
c) Description of selected adverse reactions: Macular edema (including cystoid macular edema): There were 14 cases (5.2%) with macular edema including cystoid macular edema. Events were mild to moderate in severity and vision returned to baseline with local treatment of corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs) and discontinuation of Eybelis. All of the events were found in patients with IOL inserted eye and the only currently identified risk factor for developing macular edema is pseudophakia (see Contraindications).
If symptoms such as worsening vision or visual impairment are found, vision should be checked and detailed ophthalmoscopy should be performed immediately.
Additional testing such as optical coherence tomography (OCT) or fluorescence fundus angiography may be considered if available. If macular edema is present, appropriate measures such as discontinuation of this product should be taken (see Precautions).
Iritis: There were 4 cases (1.5%) with iritis and 5 cases (1.9%) with anterior chamber cells. Inflammation was generally mild in severity and resolved with local treatment with corticosteroids or NSAIDs, or discontinuation of Eybelis. No significant impact to IOP or vision was reported (see Precautions).