Allergan PLC (AGN - Free Report) announced positive top-line results from a phase III study, evaluating its pipeline candidate Bimatoprost SR. Bimatoprost SR is Allergan’s investigational implant, developed as the first sustained-release drop-free treatment option for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The phase III study (n=594) compared Bimatoprost SR applied on patients with open angle glaucoma or ocular hypertension with timolol eye drops. The trial used two dosages of Bimatoprost SR administered in three cycles (Day 1, Week 16 and Week 32) compared with timolol eye drops, used twice daily for up to 20 months.
Data from the study showed that Bimatoprost SR reduced IOP by approximately 30% over the 12-week primary efficacy period, demonstrating non-inferiority in case of timolol.
Well received by the patients, Bimatoprost SR showed potential for patients staying on treatment free for more than a year after the last implant was inserted.
In glaucoma patients, uncontrolled elevated IOP can lead to vision loss. In order to reduce elevated IOP, patients are prescribed eye drops. However, 80% of glaucoma patients fails to use eye drops as prescribed. Bimatoprost SR, if approved, will provide such patients with an option of a drop-free therapy and free them from daily eye drop regimens. Bimatoprost SR is designed to lower IOP for at least four months.
Allergan is expected to report additional data and results from a second phase III study with an identical design in the first half of 2019. A new drug application (NDA) filing to the FDA is also anticipated during the second half of 2019.
We would like to remind investors that earlier this week, Allergan announced that its second anti-CGRP candidate, atogepant, met its primary endpoint in a mid-stage study. The CGP-MD-01 study evaluated five doses of atogepant for the prevention of episodic migraine over 12 weeks. Atogepant achieved a reduction of statistical significance in monthly migraine/probable migraine (MPM) headache, days from baseline for all doses.
Allergan’s another oral anti-CGRP acute migraine treatment, ubrogepant, has already shown positive results in two phase III studies. However, the migraine market is growing extremely competitive. In May, Amgen (AMGN - Free Report) and its partner Novartis (NVS - Free Report) received approval for commercializing their anti-CGRP drug, Aimovig, for treating episodic migraine.
So far this year, shares of Allergan have increased 4% compared with the industry’s rise of 2.4%.
Allergan currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Eli Lilly and Company (LLY - Free Report) with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Eli Lilly’s earnings per share estimates have been revised 5.7% upward for 2018 and 3% for 2019 in the last 60 days. The stock has inched up 1.5% year to date.
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