There were no serious adverse events reported in any study group. Two patients in the abicipar pegol 2mg arm and three patients in the abicipar pegol 1mg group experienced ocular inflammation adverse events. The complete data from the Stage 3, Phase 2 study will be presented at a retina meeting in the second half of 2014.
Allergan has been working to enhance the manufacturing process for abicipar pegol and will initiate Phase 3 studies in the second quarter of 2015, when material from the new manufacturing process is available. In the phase 3 program, Allergan will compare abicipar 2mg dosed every 8 weeks, abicipar 2mg dosed every 12 weeks and ranibizumab dosed every 4 weeks. All patients in the phase 3 program will receive three loading doses of drug.
Bimatoprost Sustained-Release Implant
Allergan has reviewed data from its Phase 2 clinical trials of bimatoprost sustained-release implant for the treatment of elevated intraocular pressure and glaucoma. Patients in this trial received a bimatoprost sustained-release implant in one eye and topical bimatoprost in the contralateral eye. The data suggests that bimatoprost sustained-release implant efficacy is comparable to daily topical bimatoprost with duration of 4-6 months.
Allergan has shared the bimatoprost sustained-release implant data with the FDA and the FDA is supportive of the company’s decision to advance to Phase 3 clinical trials. The Phase 3 clinical trials will be initiated by the end of 2014. If approved, the bimatoprost sustained-release implant may have the potential to change the treatment paradigm for patients who currently rely on daily topical eye drops to treat their condition.
(dexamethasone intravitreal implant) 0.7 mg
Allergan has received approval from the FDA for OZURDEX
as a new treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who 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 currently impacts more than 560,000 Americans.
It is an eye condition that can occur in people with diabetes (types 1 and 2) and causes fluid to leak into the part of the eye where focusing occurs (macula), causing blurred vision, vision loss and eventual blindness.
implant uses the proprietary and innovative 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.
“The approval of OZURDEX
for certain patients with DME further strengthens Allergan's leadership position in ophthalmology and the retina subspecialty,” said Scott M. Whitcup, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, Allergan. “In addition to receiving this important FDA approval, we are also pleased that two of our innovative pipeline programs are advancing to Phase 3 clinical development. These therapies involve novel molecules or innovative drug delivery systems which may help to improve patient outcomes.”
SEMPRANA™ (dihydroergotamine), formerly LEVADEX
Allergan has received a Complete Response Letter (CRL) from the FDA to its New Drug Application (NDA) for SEMPRANA™ (dihydroergotamine), formerly referred to as LEVADEX
, which is being developed as an acute treatment of migraine in adults. In the CRL, the FDA acknowledged that Allergan has made improvements in the canister filling process.
The two specific items listed in the CRL are related to 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 and Allergan received draft labeling from the FDA for the product in June 2013. Allergan plans to meet with the FDA and will work to fully address these issues to the satisfaction of the FDA. The Company estimates that the next FDA action will occur by the end of the second quarter of 2015.