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Aerie (AERI) Starts Late-Stage Study to Treat Dry Eye Disease

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Aerie Pharmaceuticals (AERI - Free Report) announced that it has started dosing patients in the phase III COMET-2 study with AR-15512, its investigational ophthalmic solution, for the treatment of signs and symptoms of dry eye disease (DED).

While the primary efficacy assessment of the COMET-2 study is tear production, which will be measured by the unanesthetized Schirmer test (sign), the key secondary measure is dry eye symptoms, based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire. The study will also evaluate participants based on other assessments at multiple timepoints throughout the study tenure.

Top-line data from the study is expected in the second half of 2023.

The COMET-2 study will evaluate the safety and efficacy of AR-15512, a TRMP8 agonist, in patients with DED. The study will randomize participants to either receive AR-15512 (0.003%) or AR-15512 vehicle, dosed twice daily in each eye, for three months.

Shares of Aerie have declined 19.5% in the year so far compared with the industry’s 25.8% decrease.

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The initiation of the COMET-2 study is based on data from the phase IIb COMET-1 study, which evaluated AR-15512 in DED patients. While the study did achieve a statistical significance over multiple pre-specified symptoms and sign endpoints, it did not achieve all pre-determined primary endpoints with statistical significance.

The COMET-2 study is one of the three studies in the phase III registrational program, seeking approval for AR-15512 to address DED. Aerie plans to start the COMET-3 study, which is identical to the COMET-2 study, in third-quarter 2022. Management also aims to begin the phase III COMET-4 study, which is also a 12-month safety study, in fourth-quarter 2022.

AERI expects data from these three studies to support a potential new drug application (NDA), seeking approval for AR-15512 to treat DED. Aerie expects to file the NDA in 2024.

Zacks Rank & Stocks to Consider

Aerie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are Abeona Therapeutics (ABEO - Free Report) , Alkermes (ALKS - Free Report) and Angion Biomedica (ANGN - Free Report) , each of which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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