Alcon’s Strategic Move: AR-15512 Breakthrough in Dry Eye Treatment

Alcon’s recent acquisition of Aerie Pharmaceuticals for $770 million is proving to be a strategic triumph, as their lead candidate, AR-15512, demonstrates promising results in two critical phase 3 trials for dry eye disease. Approximately 930 participants were randomized in these trials, with those receiving AR-15512 showcasing a noteworthy increase in tear production after a 14-day regimen, meeting the primary endpoint with a statistically significant p-value below 0.0001.

Early observations by Alcon indicate tangible improvements in tear production from the very first day of treatment, and these effects endured throughout the 90-day observation period. While specific trial data remains undisclosed, Alcon is actively preparing to submit an application for FDA approval by mid-2024. 

Simultaneously, the company is concluding a comprehensive long-term safety study, underscoring its commitment to ensuring the drug’s effectiveness and safety.

This development positions Alcon as a frontrunner in providing a groundbreaking treatment for dry eye disease, a prevalent condition affecting an estimated 38 million Americans. Of concern is that around 20 million of these cases remain undiagnosed, and less than 10% of those diagnosed currently opt for prescription drugs. Alcon’s novel approach with AR-15512, distinct from conventional treatments targeting inflammation, holds significant potential to address this unmet need.

Unlike traditional therapies like Bausch + Lomb’s Xiidra, AR-15512 operates on a distinct mechanism linked to the TRPM8 receptor, associated with detecting ocular surface dryness. 

Recently disclosed results from Phase III clinical trials, COMET-2 and COMET-3, highlight AR-15512’s efficacy in improving the production of tears among dry eye patients. Alcon’s official release emphasized that the treatment led to a substantial proportion of patients achieving a significant improvement in tear production, reaching statistical significance by day 14.

Alcon found the drug to be well-tolerated, with no serious side effects reported making it a viable option for patients with dry eye.

Alcon CEO David Endicott expressed confidence in AR-15512’s potential to address the limitations of existing dry eye prescriptions. The drug’s swift onset of action meets a critical gap in current dry eye medications, presenting an encouraging prospect for individuals grappling with this chronic condition.

Worth noting is the origin of AR-15512 from Aerie Pharmaceuticals, which Alcon acquired in August 2022. 

In contrast to recent setbacks in the dry eye disease domain, such as the FDA’s rejection of Aldeyra Therapeutics’ reproxalap, Alcon’s AR-15512 instills renewed hope. The positive outcomes from COMET-2 and COMET-3 trials underscore the drug’s potential, charting a promising trajectory for an FDA application in mid-2024.

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