👓 So long reading glasses, here come eye implants!
Are biological inlays the future of presbyopia?
Hello and welcome to Careviser by Marie Loubiere, the weekly newsletter that cuts through the healthcare noise with a single focus: productization of the latest research and tech breakthroughs.
Patients hate reading glasses, they make them look and feel old. Yet as the world population ages, more and more people suffer from presbyopia and need help for near sight. Can technology replace reading glasses?
The future of refractive surgery: presbyopia treatment, can we dispense with our glasses? by Parwez Hossain & Ramez Barbara is an editorial in Eye building on Refractive surgery beyond 2020 by Marcus Ang, Damien Gatinel, Dan Z. Reinstein, Erik Mertens, Jorge L. Alió del Barrio & Jorge L. Alió.
🗝️ Why it matters: Presbyopia prevalence grows as the population ages and it can affect patients as early as 30 years old.
🔎 Current treatments:
Traditionally, presbyopia was corrected with single‐vision near, bifocal, and progressive spectacle lenses, but also with multifocal contact lenses. The main benefit is that they are flexible and can dynamically correct presbyopia as it evolves over time. Manufacturers have focused new product launches on ‘free form digital’ progressive lenses with dynamic accommodation of wider optical zones.
This is often cited by manufacturers as ideal for our ‘modern presbyope’ who needs to have a single pair of glasses that gives clear vision at a variety of viewing distances such as moving from computer screens to mobile phones and vice versa.
✅ There is a lack of peer-reviewed literature showing the effectiveness of ‘free form digital’ progressive lenses.
Refractive surgery has evolved a lot in the past thirty years. There are a variety of techniques and procedures such as PRK, LASIK (pretty well known from the general public as it was even featured during an episode of Keeping up with the Kardashians) and minimally invasive laser eye treatment-SMILE.
✅ Current studies show that patients are happy with the outcomes, however most of them are focused on myopia. More research needs to be done to show its effectiveness for presbyopia.
Surgery also needs to evolve to be able to dynamically correct presbyopia similarly to spectacle lenses.
Corneal inlay is an exciting field of surgery that has advanced a lot recently. They possess many benefits: no tissue is removed, and the procedure can be reversed, leaving the opportunity to do additional surgical procedures in the future. However a few patients experience side effects such as dry eyes and impaired night vision that have prevented the procedure from becoming popular.
Based on inlay technology, scleral expansion surgery is an emerging field of eye surgery. It increases the distance between the lens equator and the ciliary body. Its effectiveness remains to be proven, and one American manufacturer Refocus Group has a CE mark and is undergoing clinical trials.
SMILE surgery also opens the door for biological inlays. The extracted corneal lenticels could be transplanted to other patients’ to correct their refractive errors. In theory biological inlays would be better tolerated than synthetic ones. However this comes with risks such as viral transmission. The potential of such techniques needs to be explored further and clinical pathways developed accordingly.
Orasis Pharmaceuticals is a biotech founded in Israel in 2015.
💦 Product: Orasis develops eye drops that correct presbyopia temporarily (for a few hours) effectively replacing reading glasses.
📊 Progress: at the end of 2020, they announced that they reached two major milestones:
The eye drops successfully passed the phase IIB of clinical trial, and will start phase III in April 2021 in the US meaning that they could market their eye drops as early as 2022/2023.
They raised a US$30m series C with Bluestem Capital, a PE dedicated to eye solutions (Visionary Fund) and returning investors from the previous rounds (Sequoia, Maverick…).
🚀 Go-to-market: they are focused on the US market where most prescription glasses are sold over-the-counter. It isn’t clear whether they aim to compete with OTC glasses or with prescription ones which raises two questions:
User-friendliness: While patients hate wearing reading glasses that make them “look old”, they are extremely convenient to use as a product. You put them on and that’s it. The process of putting eye drops every time you want to read is time-consuming. So it raises the question of patients' adoption of the eye drops. Especially if sold in retail where you’ll need to show the benefits of a novel solution on a shelf next to reading glasses that patients know very well.
Distribution: if distributed in retail (CVS, Walmart etc…), Orasis will need to invest a significant amount of money in 1. Setting up distribution agreements, 2. Marketing campaigns including in-store to push the eye drops. That’s a totally different ball game than being successful at going through all the phases of a clinical trial. So far, the Orasis team is small (less than 10 people) and focused on clinical trials and manufacturing, so they will need to step up their game on the sales and marketing side. Their CEO was the GM of a company selling consumer goods (hair care, lip care) to pharmacies and supermarkets so that will prove useful when they start marketing.
👩🏾🤝👩🏼 New players:
Visus Therapeutics was founded in 2019 by a team of veterans that had merged two companies together (Lumos Diagnostics and RPS Diagnostics). They aim to develop prescription eye drops that can correct presbyopia for up to 12 hours. That would enable patients to apply eye drops only once a day. They have only started Phase II at the beginning of the year.
Nthalmic was also founded in 2019 and doesn’t disclose much about the solutions they are currently developing. I would bet they are developing a new type of contact lenses. To be followed...
I usually only cover new businesses but I thought it would be interesting to discuss ReVision Optics. ReVision Optics closed in 2018 after having raised more than US$150m in funding for its corneal inlay. It was the second eye inlay to be approved by the FDA. ReVision Optics was funded by a very experienced medtech team. It was marketed for about a year and was used in approximately 1,000 procedures. They closed citing business concerns:
They estimated that they would need an additional $US50m in funding to grow to the desired volume of procedures.
They said that the presbyopia market is “very challenging” so their go-to-market was a struggle:
Ophthalmologists favor surgery which can be done as a one-time treatment when inlays require at least one-follow non-profitable visit.
There were reports of serious side-effects to the treatment such as haze.
It is an interesting tale of how despite an innovative product, the company needed yet even more time and funding to push adoption with providers whose very practical concern (limited number of follow-up visits) were not aligned with the clinical workflows required by the device.
That’s a wrap for today! Don’t hesitate to reply to this email with comments, I read and answer all emails :)