Allergan's (AGN) Glaucoma Implant Durysta Gets FDA Approval

Allergan plc (NYSE:AGN) announced that FDA has approved its new drug application seeking approval of biodegradable implant bimatoprost to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Bimatoprost implant will be marketed by the trade name of Durysta and is the first sustained-release drop-free treatment option approved in the United States for the indication.

In the past year, Allergan’s share price has risen 34.9% against the industry’s decrease of 1.8%.

The NDA was supported by data from two pivotal phase III ARTEMIS studies. The phase III studies compared Durysta with timolol eye drops, a FDA standard comparator. Data from the studies showed that Durysta reduced IOP by approximately 30% over the 12-week primary efficacy period, demonstrating non-inferiority to timolol.

Glaucoma, which affects an estimated 70 million people globally, can lead to irreversible vision loss. Reducing elevated IOP can slow the progression of vision loss associated with glaucoma. At present, eye drops are the standard first-line treatment option for lowering IOP in OAG patients. However, some patients face challenges with topical drops and need alternative options, which opens up market opportunity for Durysta

Allergan continues to evaluate Durysta in five other phase III studies to support further label expansion.

Earlier this week, AbbVie (NYSE:ABBV) and Allergan announced that the European Commission (EC) has approved the divestiture of Allergan’s mid-stage candidate for autoimmune disease, brazikumab to AstraZeneca. AbbVie is due to buy Allergan in a cash-and-stock deal for $63 billion. Allergan announced a definitive agreement to divest brazikumab and marketed medicine, Zenpep to AstraZeneca (NYSE:AZN) and Nestle, respectively in January in connection with the pending merger.

The EC had approved the merger in January, conditional on the divestiture of brazikumab. The EC’s final approval clears the path in Europe for the pending merger to get through. However, the transaction remains subject to some other customary closing conditions including Federal Trade Commission’s (FTC) decision, which is expected early in the second quarter of 2020.

Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large drug company is Pfizer (NYSE:PFE) , which carries a Zacks Rank #2 (Buy). Its earnings estimates have risen 3.6% for 2020 over the past 30 days.

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