预约演示

Alcon’s dry eye ambitions take off as $770M Aerie takeover delivers phase 3 wins

2024-01-10

临床3期临床结果并购

Alcon says dry eye affects an estimated 38 million people in the U.S.

Alcon’s $770 million takeover of Aerie Pharmaceuticals has delivered an early win. The lead candidate in the acquired pipeline met the primary endpoint in a pair of phase 3 dry eye trials, positioning Alcon to file for FDA approval in the middle of the year.

Alcontudies randomized around 930Aerie Pharmaceuticalsto receive AR-15512, a topical transient TRPM8 agonist, or vehicle control. After 14 days, a higher proportion of patients on AR-15512 had a 10 mm Alconeater increase in tear production, causing the program to meet its primary endpoint with a p value of less than 0.0001.

Alcon saw improvements in tear production as early as day one. ThAR-15512s persisted through toTRPM8 agonist TRPM890, although the former Novartis unit is yet to share data from the trial. AlconAR-15512 yet to comment on the phase 3 trial’s other secondary endpoints such as ocular discomfort, which was once a focus of AR-15512 development.

Alcon512 failed to improve tear production or ocular discomfort on day 28 in an earlier study, causing that trial to miss itNovartismary endpoints. Aerie looked past the setbaAlconocused on successes against secondary goals—including tear production at day 14—designed a phase 3 program around the lessons AR-15512arlier trial and was rewarded with a buyout bid from Alcon, plus positive top-line phase 3 data.

AR-15512ans to use the data, which is free from serious ocular adverse events, to file for FDA approval in the middle of 2024. Talking to investors Aeriequarterly results conference call in November, Alcon CEO David Endicott said it would “probably take four months, five months to get [the data] into a submission format.” The eye care specialist is also working to Alconup a long-term safety study by April.

Alconval will position Alcon to start selling a first-in-class treatment for dry eye disease, a condition that the company says affects an estimated 38 million people in the U.S. Around 20 million of Alcon people are undiagnosed, according to Alcon, and fewer than 10% of people with a diagnosis take a prescription drug.

Most patients initiallyAlconartificial tears, and most pharmacologic topical dry eye diseaseuding Bausch + Lomb’s Xiidra, target inflammation. AR-15512 has a different mechanism, as researchers have tied TRPM8 to the detection of ocular surfacAlconness.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构