Sending the biopharmaceutical company Alimera Sciences Inc's experimental’s shares down 41 per cent in after-market trade, the U. S. Food and Drug Administration declined to approve drug to treat retinal swelling in its current form.
Company's two late-stage trials to further assess the relative benefits and risks of the drug was conducted and the Alpharetta, Georgia-based company said the FDA has not asked for any new clinical trials, but requires more safety and efficacy data from the trial.
The most prevalent cause of moderate vision loss in patients with diabetes called diabetic macular edema is what Alimera is attempting to treat by developing the drug Iluvien in partnership with pSivida Corp.
The company informed that for more information on controls and specifications concerning the manufacturing, packaging and sterilization of the drug, the FDA has asked the company to submit details.
This data is currently being compiled by the company.
The company further informed that during its facility inspections of two of Alimera's third-party manufacturers in August and September, the FDA found deficiencies in current good manufacturing practices, cGMP.
Alimera shares were down 41 per cent at $6.66 in extended-trade. These shares had gained 39 per cent since its drug got a priority review in end-August.
