More for 2024 (2 new dry eye medications in the pipeline)
Alcon ( a pharmacy that “grew up” with eye care-related pharmaceuticals and has evolved into a major player in the world of dry eye treatments) has been testing a new drop for dry eye care, known so far, as AR-15512 (a “transient receptor potential melastatin 8 (TRPM8) agonist,” for those in the know). This group of compounds can stimulate the nerves responsible for the sensation of cold temperature and appears to regulate the production of tears. Early work with menthol showed it could trigger this response - but even small doses applied to the surface of the eye would cause irritation and it was deemed unlikely to be useful - despite its ability to make eyes tear. Subsequent compounds have been tested and found to be less irritating and more useful in provoking tear production. Early Alcon studies of this medication have been named “Comet” and the most recent Comet 2 and Comet 3 studies have continued to be promising - enough that Alcon aims for its application to the FDA by mid-2024. Stay tuned for more on this! (links about this here: https://www.optometrytimes.com/view/positive-results-reported-from-phase-3-comet-trials-of-alcon-s-ar-15512-for-dry-eye?utm_source=sfmc&utm_medium=email&utm_campaign=01132024_OD_eNL_Dave%20Kading%20CBR%20TD_IKA%20house%20ad&eKey=ZWphY2NvbWFAYW9sLmNvbQ== and https://escholarship.org/content/qt2gz2d8s3/qt2gz2d8s3.pdf?t=qaeax8 )
Last week, I gave a nod to Stuart Therapeutics and their phase 3 studies of a polypeptide they call ST-100 or Vezocolmitide. This week, “Okyo Pharma announced positive safety and efficacy data from its phase 2 trial of OK-101 ophthalmic solution, a lipid-conjugated chemerin peptide agonist designed to reduce pain and inflammation in patients with dry eye disease.” Recalling that peptides are the building-blocks of proteins, and that our bodies are made up of countless proteins, it is perhaps no surprise that any substance that can direct protein production or affect protein pathways can likely influence tears (containing proteins) and the surface of our eyes (also regulated by proteins). This new drug was shown in phase 3 studies to improve the signs and symptoms of dry eye disease. Stay tuned for more on this! (links about this here: https://www.healio.com/news/optometry/20240109/ok101-achieves-dry-eye-disease-sign-symptom-endpoints-in-phase-2-trial#:~:text=1%20min%20read-,OK%2D101%20achieves%20dry%20eye%20disease%20sign%2C%20symptom,endpoints%20in%20phase%202%20trial&text=Okyo%20Pharma%20announced%20positive%20safety,patients%20with%20dry%20eye%20disease. and https://www.optometrytimes.com/view/positive-phase-2-results-of-ok-101-for-dry-eye-disease-revealed-by-okyo-pharma?utm_source=sfmc&utm_medium=email&utm_campaign=01132024_OD_eNL_Dave%20Kading%20CBR%20TD_IKA%20house%20ad&eKey=ZWphY2NvbWFAYW9sLmNvbQ== )
Lastly, in response to numerous concerns raised during 2023 about contaminated eye drop products that caused eye infections and even deaths, the FDA has revised its guidelines. Optometry Times provided the following information: “This revised draft guidance revises guidance of the same name from October 2023, “Quality Considerations for Topical Ophthalmic Drug Products.” Specifically, the revision discusses microbiological considerations related to product sterility for all ophthalmic drug products subject to current good manufacturing practice (CGMP) requirements. It is intended for the prevention of contamination of ophthalmic drug products packaged in multidose containers.1
Quality considerations for ophthalmic drugs such as gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions, intended for topical delivery in and around the eye, are addressed in the revision.” Initial interpretation of earlier guidelines caused some manufacturers to believe the FDA rules did not apply to over the counter products and this revision makes it clear that these current good manufacturing processes apply across the board to prescriptive and OTC products. The expectation is that this should help prevent future eye injuries. A link to the FDA guidelines here: https://www.optometrytimes.com/view/fda-challenges-quality-requirements-for-ophthalmic-drugs-with-revised-draft-guidance?utm_source=sfmc&utm_medium=email&utm_campaign=01132024_OD_eNL_Dave%20Kading%20CBR%20TD_IKA%20house%20ad&eKey=ZWphY2NvbWFAYW9sLmNvbQ==
Some helpful eye drop safety information shared by Rebecca Petris of the Dry Eye Foundation: https://www.dryeyefoundation.org/
Lastly, for tips on keeping your eye drops sterile and safe, this video link was also shared: https://www.eyedropsafety.org/news/blog/preservative-free-eye-drops-how-to-reduce-the-risk-of-bacterial-contamination
Stay safe!
To schedule an appointment with Dr. Jaccoma, call Excellent Vision at either of these two dry eye offices:
(1) 155 Griffin Rd, Portsmouth, NH 03801 (603) 574-2020
(2) 3 Woodland Rd, STE 112 Stoneham, MA 02180 (near Boston) (781) 321-6463