Former Allergan program posts positive topline PhIII results in presbyopia in an R&D win post-AbbVie merger
Allergan announced that a pair of Phase III studies for an experimental ophthalmic solution in presbyopia, an age-related condition resulting in a problem focusing on nearby objects, met their primary endpoint in vision tests associated with the condition. The data puts the program on track for a NDA sometime in the first half of next year.
AbbVie shares were muted on the news, trading down about 1% in morning trading sessions.
The solution, dubbed AGN-190584, contains a formulation of pilocarpine, a cholinergic muscarinic receptor agonist that modulates the way iris muscles in the eye expand and contract. Through the program, Allergan is hoping to improve patients’ nearsighted vision and depth of focus in low lighting.
Both studies were placebo controlled and enrolled a total of 750 patients. The first trial’s topline results saw patients able to read three or more additional lines on an eye exam reading chart in low light, a statistically significant greater proportion compared to placebo. Secondly, the next trial met a similar primary, with more patients gaining three lines without loss of more than five letters in the vision test.
Allergan did not divulge the exact number of patients seeing these improvements.
The company also reported meeting the majority of secondary endpoints in both studies, including a significant improvement in patient-reported outcomes such as an increase in reading ability, reductions in the impact of their presbyopia on daily life and use of coping behaviors to manage their vision.
On safety, there were no serious adverse events related to the treatment. The most frequently reported side effects were headache, conjunctivitis, blurred vision and eye pain.
AGN-190584’s topline results Wednesday represent an R&D victory for the formerly troubled Allergan, whose pipeline has not seen much success since AbbVie announced the takeover in June 2019. The duo’s first post-merger drug struck out as the FDA spurned the wet AMD drug abicipar a few months ago, and a UroGen Phase II trial looking at repurposing Botox overactive bladder and urinary incontinence failed in August.
Given that AbbVie’s acquisition of the company centered largely around the $16 billion Botox franchise, the company has been siphoning off several former Allergan R&D projects. AbbVie ended an experimental gastro drug deal in June and nixed an alliance related to CRISPR tech in August. The pilocarpine solution was not one of the four that former Allergan CEO Brent Saunders had held up as an “expected” approval, though abicipar fell into that category.