Are you reading this article using prescription reading glasses? If yes, there is a high chance that you are above 40 years of age, and had to put on these reading glasses once you crossed 40, as you could not see nearby objects. Maybe you could not read messages on your phone upon waking up, or had trouble reading emails on your laptop, or even reading the fine print on plain old paper. Eventually you had to visit your friendly neighborhood eye doctor (ophthalmologist), who may have prescribed your reading glasses.This condition is called Presbyopia and currently 128 million Americans are affected by it. Many of us, including the author of this article, have wondered if there is a cure for this, as the annual visit to the ophthalmologist results in prescriptions that keep increasing the power of the reading glasses every couple of years, as the eyes tend to deteriorate over time even more. The answer to this - Vuity Eye Drops - was launched in November 2021 by Allergan (an AbbVie company which specializes in eye care), to address Presbyopia (read the press release).The Vuity launch was featured as the 5th Most Influential Health Project in 2022 by PMI (read more). Why is this significant? This is the first drug that treats the Presbyopia condition in adults that was approved by the FDA, and enables us to ditch our prescription reading glasses.What causes Presbyopia? (Joshua Murdock, 2022)
- Getting older may lead to presbyopia. This is because the lenses in our eyes can naturally stiffen with age.
- Normally, when you look at objects or text up close, muscles in your eyes squish your lenses so they’re a bit thicker than they were before. When your lenses bend into a rounder shape, it’s easier to focus on close-range objects. But if your lenses stiffen over time, it's harder for them to change shape and focus on small details that are close to you.
Vuity is a prescription drug that treats Presbyopia in adults. How does it work ? (Joshua Murdock, 2022)
- Vuity works by making your pupils temporarily smaller so they can focus on objects that are close to you. It does this by affecting chemical binding sites in your eyes called muscarinic receptors. When Vuity binds to these receptors, it makes muscles in your eye contract. In turn, this makes your pupils smaller. This helps improve focus, which enhances near-range and intermediate-range vision. It doesn’t affect long-range vision.
- The drug starts working within 15 minutes and can continue working on improving vision for up to 6 hours.
From a project management perspective, for the launch of a drug like VUITY, the Allergan teams would have had to consider the major milestones in the drug discovery lifecycle, especially the critical phase of clinical trials that eventually lead to a successful regulatory approval and eventually a commercial launch.Articles related to the lifecycle and the clinical trials phases mentioned, throw light on these complex and often lengthy and risk-laden phases to manage and eventually complete successfully, all against tough market pressures (and for Allergan, beating out competitors such as Alcon, Bausch and Lomb and Novartis). More information on the clinical trial for Vuity that ultimately secured its approval by FDA.These articles highlight the tough challenges the PMO in any drug development organization faces, as summed up by Divya Yerraguntla and Srinivasan Sriram in their April 2020 monthly meeting presentation to PMINJ: “Product launches are complex due to global and local alignments and the involvement of cross-functional teams. To be able to master the complexity and achieve high performance through successful product launches, several key success factors need to be considered”.
References:
- Murdock, Joshua (October 20, 2022) — Vuity Eye Drops for Presbyopia: Effectiveness, Cost, and More
- Sriram, Srinivasan and Yerraguntla, Divya - Commercialization and Portfolio Optimization for Pharma – PMI NJ Chapter Monthly meeting presentation, April 21, 2020 (PMINJ member login required)
