Alcon tees up FDA filing after dry-eye drug succeeds in Phase III
10 Jan 2024
Clinical ResultPhase 3Drug ApprovalAcquisition
Top-line results from two Phase III efficacy trials suggest Alcon's experimental dry-eye therapy AR-15512 could grab a significant chunk of the US market from mainstay treatments Xiidra (lifitegrast) and Restasis (ciclosporin). Based on findings from the COMET-2 and COMET-3 trials, the Novartis spinout said it plans to file its topical dry-eye candidate with the FDA in mid-2024.
Novartis offloaded Xiidra and its other "front of eye" assets to Bausch + Lomb in a deal worth up to $2.5 billion last year. XiidraXiidra, which was approved by the FDA for dry-eye disease in 2016, generated sales of $185 million in the first half of 2023. Restasis, which is marketed by AbbVie, brought in $308 million in the first nine months of last year.
Alcon acquired AR-15512 through its $770-million purchase of Aerie Pharmaceuticals. The TRPM8 agonist acts as a thermoreceptor modulator to stimulate the cold sensing receptors found on nerve endings that supply the cornea and eyelids. The company said that both the COMET-2 and COMET-3 studies, which enrolled a total of more than 930 participants, achieved the primary endpoint of ≥10mm increase in unanaesthetised Schirmer's score, a measure of tear production, after two weeks.
Addressing the rapid onset gap
According to Alcon, secondary endpoints also demonstrated the drug's rapid onset compared to vehicle, beginning as early as the first day and persisting through to day 90. UBS analysts view this as an even more encouraging sign, noting "this could be an important commercial factor given it looks to deliver an onset of action well ahead of marketed drugs." Meanwhile, there were no serious ocular safety events reported in either study, although the COMET-4 safety trial in 275 patients is ongoing.
Alcon suggested there is a large untapped market for dry-eye disease treatments. While the condition is estimated to affect 38 million people in the US, the company said only about 18 million are diagnosed and
UBS estimates AR-15512 could post sales of just over $1 billion annually at its peak by 2030. "Even if there are competitive challenges, we still think – assuming the detailed data supports the headline conclusions – the drug can generate sales comparable to Xiidra" of about $600 million, they added.
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