Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline

Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline

Alcon is buying in pipeline prospects to support its expansion into the eye drug market, striking a $770 million takeover of Aerie Pharmaceuticals to add two approved therapies and a clutch of investigational treatments for retinal and ocular surface diseases.

Aerie’s most advanced pipeline prospect is AR-15512, an ophthalmic solution in late-phase development as a treatment of patients with dry eye disease. The candidate, which contains a selective agonist of the TRPM8 ion channel, failed a phase 2b clinical trial last year. After 28 days of treatment, participants on AR-15512 did no better on measures of eye discomfort and tear production than their peers on placebo did.

While the failures caused the study to miss its co-primary endpoints, Aerie pointed to success against a set of secondary goals, including eye discomfort and tear production at other time points, to make the case for further development. Aerie moved into phase 3 registrational trials in the second quarter.

The two studies, COMET-2 and COMET-3, are now enrolling patients with dry eye disease to evaluate the effects of AR-15512 0.003%, one of two doses tested in the phase 2b. The primary endpoint is based on unanesthetized Schirmer test scores at Day 14, one of the secondary measures that AR-15512 hit in the midphase clinical trial. Aerie has relegated ocular discomfort to a secondary endpoint.

Alcon has a short wait to find out whether Aerie’s continued confidence in the candidate is justified. COMET-2 and COMET-3 have primary completion dates of March and May 2023, respectively, on If the studies show AR-15512 to be effective, Alcon could seek FDA approval of the candidate in 2024.

Two sustained-release implants make up the rest of Aerie’s clinical-phase pipeline. The company finished a phase 2 clinical trial of a dexamethasone steroid implant in patients with macular edema because of retinal vein occlusion in 2020. However, rather than advance the implant, AR-1105, immediately, Aerie paused to evaluate phase 3 development options and partnership opportunities.

The other candidate, AR-13503 SR, contains a ROCK and protein kinase C inhibitor. Aerie began a phase 1 trial in 2019 but put development on hold pending an assessment of its capital allocation. The company has a third sustained-release implant, which delivers the VEGF inhibitor found in Pfizer’s Inlyta, that is set to reach the IND filing stage by the end of the year.

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