FDA Approves Allergan’s Ozurdex for Diabetic Macular Edema
Company’s Semprana receives Complete Response Letter
Allergan has received FDA approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg to treat diabetic macular edema (DME) in adults who have an artificial lens implant (pseudophakic) or are scheduled for cataract surgery (phakic).
Ozurdex is a sustained-release biodegradable steroid implant that demonstrated long-term efficacy without the need for monthly injections.
DME, an eye condition that affects more than 560,000 Americans, can occur in people with diabetes (types 1 and 2). It causes fluid to leak into the macula, causing blurred vision, vision loss, and eventual blindness.
The Ozurdex implant uses the Novadur solid polymer delivery system — a biodegradable implant that releases medicine over an extended period of time — to suppress inflammation, which plays a key role in the development of DME.
Ozurdex was already FDA-approved to treat adults with macular edema following branch retinal vein occlusion or central retinal vein occlusion and to treat adults with noninfectious uveitis affecting the back segment of the eye.
The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, and high blood pressure.
Allergan announced the Ozurdex approval as part of an update on key research and development pipeline programs. The company also said that it has received a Complete Response Letter (CRL) from the FDA regarding Semprana (dihydroergotamine, formerly Levadex), an inhalation aerosol that is being developed as an acute treatment of migraine in adults.
According to Allergan, the CRL focused on “specifications around content uniformity on the improved canister filling process and on standards for device actuation. There were no issues related to the clinical safety and efficacy of the product.” The company will work with the FDA to address the issues and “estimates that the next FDA action will occur by the end of the second quarter of 2015.”
Source: Allergan; June 30, 2014.