FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

MHRA Recommends Oxervate Eye Drops for Early Access Scheme

June 13, 2017
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The U.K.’s Medicines and Healthcare Products Regulatory Agency issued a positive opinion for pre-approval access to Dompe Farmaceutici’s Oxervate eye drops for the treatment of neurotrophic keratitis, a degenerative corneal disease most commonly caused by certain infections and surgeries.

Successful treatment will lead to reduced need for surgery, the MHRA said, adding that there is currently no such drug therapy available in the U.K.

Oxervate was studied in two Phase II clinical trials involving more than 200 patients. After eight weeks of treatments, nearly 75 percent of patients in one study saw complete corneal healing compared to 43.1 percent with placebo. Dompe has committed to supplying long-term follow-up safety data.

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