Sheryl brings a wealth of editorial experience to MJH Life Sciences’ Eye Care Network, having engaged with the readers and the greater ophthalmic community of 

for more than 20 years. As Group Editorial Director, Sheryl’s purview extends across the print and digital network of 

Ophthalmology Times, Ophthalmology Times Europe, Modern Retina 

 Prior to ophthalmology, Sheryl previously covered the fields of audiology and confectionery science/technology/manufacturing.

Sheryl is also passionate about the mission, vision and values of Ophthalmic World Leaders (OWL) and recently completed her term on its Board of Directors. She continues to volunteer as Editor-in-Chief of the organization’s 

Magazine. In 2013, she was honored with the group’s inaugural Rising Star Award.

In addition, she has served as a judge for 

 Health Care Heroes Awards program as well as the Jesse H. Neal National Business Journalism Awards.

Sheryl Stevenson

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Videos

Dara Conlon, Executive Vice President of EURETINA, and Prof. Anat Loewenstein, General Secretary of EURETINA, discuss some key features of this year's Congress.

EURETINA leadership discusses what to expect at the 2022 Congress, outlines Women in Retina programme

Thea Pharma announces U.S. Food and Drug Administration (FDA) approval for the New Drug Application of latanoprost ophthalmic solution 0.005% (IYUZEH) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The agent is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free, according to the company.

The drug is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK).

In addition, it has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the U.S. and Europe. In randomized, controlled clinical trials of patients with OAG or OHT with mean baseline IOP of 19-24 mmHg, the drug lowered IOP by 3 – 8 mm Hg versus 4 – 8 mm Hg by Xalatan (latanoprost ophthalmic solution) 0.005%, which is preserved with BAK.

“The approval of IYUZEH is a significant milestone for Théa Group, as this is our first FDA approval for a prescription ophthalmic medicine, for our U.S. subsidiary,” said Jean-Frédéric Chibret, president of the Théa Group.

“Marketed outside of the U.S. as Monoprost, the market leading prostaglandin analogue (PGA) in volume, is available in over 46 countries around the world, including France, Germany, Spain, United Kingdom, Italy, and Canada. We are extremely proud to bring our unique preservative-free latanoprost eye drop, IYUZEH to the U.S.

“Our novel patent protected formulation has been made possible by Théa’s innovative scientists,” said Susan Benton, Thea’s U.S. President. “They were able to solve the challenges of solubilizing and stabilizing latanoprost such that IYUZEH does not need to be manufactured, distributed, or stored at refrigerated temperatures unlike some other competitive brand and generic latanoprost and PGA products. Additionally, Théa is responding to an important unmet need across all stakeholders in the treatment of OAG and OHT. Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD) that can cause discomfort for patients, frustration for physicians, and drive additional costs for payers.”

The company anticipates introducing latanoprost ophthalmic solution 0.005% to U.S. eyecare practitioners in the second half of 2023.

Articles

The company anticipates introducing latanoprost ophthalmic solution 0.005% to U.S. eye care practitioners in the second half of 2023.

FDA approval: Thea’s preservative-free latanoprost for IOP reduction in OAG, ocular hypertension

This transcript has been lightly edited for clarity.

 Hi, I'm Dr. Mitch Shultz from Los Angeles, California, and I'm here to talk to you a little bit today about the study that I've done on the iStent inject versus the Hydrus stent.

We've actually been looking now we're getting close to presenting 2-year data on this study where we implanted patients, contralateral eyes, 1 eye with iStent inject and 1 eye with Hydrus and have followed the patients prospectively over the last 2 years.

The interesting thing that's come out of this data has really been that both products work extremely well as far as target IOPs. Both products have achieved a significant reduction in patient eye drop load but we found in patients who are implanted with either stent with just the implants, they typically get off approximately 1 medication. What has been interesting is in combination with ab interno canaloplasty, we have actually been able to improve that to 1 and a half to 2 medication reduction in medication burden.
Another important fact has been the fact that 80% of patients have are now medication-free. So that's been another feature of the study.

But what has really been critical and what's really kind of changed. The way I'm doing things today is the fact that we have less adverse events in our iStent group than we've had in the Hydrus group. So what we've seen in the iStent group is zero intraoperative adverse events and zero postoperative adverse events.

Unfortunately, in the Hydrus group, there are some learning curve problems that surgeons may experience with underimplantations, overimplantations, or missing the passage and going into the superciliary space, which can lead to other problems postoperatively. We've actually seen one patient with angle closure glaucoma occur after Hydrus stent.

So I think when we're looking for safety, efficacy, iStent inject has really stood out in this group, even though both stents work very well. So thank you very much, and I look forward to seeing you around the meeting.

At AAO 2022, Dr Mitch Shultz provides discourse on iStent inject vs Hydrus contralateral eye evaluation data.

2-year data in contralateral eye evaluation gives edge to iStent inject over Hydrus stent

 We're joined today with Dr. Justis Ehlers, who is presenting this year at the American Academy of Ophthalmology. Welcome. Dr. Ehlers, could you tell us a little bit more about your talk this year?

 Sure, Sheryl. Thank you so much for having me; it's a pleasure to be able to share a little bit about the data that we're presenting at the Academy meeting.

The focus of the talk, and as some of the research that we're presenting is really around the importance of understanding what's going on from a fluid dynamics standpoint in wet macular degeneration, and how that may impact visual outcomes. There's been a lot of research that suggests that the presence of different fluids may have different impacts on overall visual acuity. In particular, some of the early data has said that subretinal fluid may be associated with better visual acuity and intraretinal fluid may be associated with more significant visual acuity loss.

Interestingly, in some of these studies, they've actually demonstrated that the presence of subretinal fluid may actually be better than not having any fluid in terms of vision. And we wanted to dive into that a little bit more in terms of evaluating ways to look at the OCT, that may have a better understanding for us as clinicians.

And what we were able to do is, using some advanced image processing, is look at the overall intact aspect of the ellipsoid zone and the integrity that's there. And really judging whether or not there may be underlying atrophy.

And what we found was interesting, and that was was that if the outer retina was intact, the retina being dry was clearly the best visual acuity outcome, really suggesting that that really is what we should push for, as clinicians. Subretinal fluid being present was the second in terms of overall visual acuity outcomes, and then intraretinal fluid, and then actually underlying atrophy being the overall worst visual acuity outcomes.

And so you can see how understanding that key feature of the outer retina really drives the difference that may push outcomes towards more limited visual acuity when you sum the entire population together.

The last piece that we looked at was this concept around volatility. And that is, is that if the fluid is changing significantly, does that have an impact overall? And one of the things that we did find that I think was sort of unexpected, was that dynamic subretinal fluid, so that is that fluid that's changing from visit to visit, appears to have a more deleterious effect on visual acuity than fluid that's static.

And so again, really understanding and as we have more and more therapeutics available to us to understand what's happening on a really monthly, and really weekly basis, for these patients will be helpful to understand how we can optimize their outcomes overall.

 Excellent. And what would be the take-home message for the clinician in their daily practice?

 I think you'll one of the key take-home messages is just use caution in terms of how quickly you extend patients, and really understanding early on--is fluid resolving? And you're not just capturing that. And I think you know, striving for the best fluid outcome early on in treatment, in terms of resolution are really the things that I've taken away from this.

 Well, thank you so much for sharing that. We look forward to learning more about your presentation.

At AAO 2022, Dr Justis Ehlers presented a talk entitled, "Defining the Fluid Problem in Neovascular AMD: To Dry or Not to Dry?"

Author | Sheryl Stevenson

Articles

FDA approval: Thea’s preservative-free latanoprost for IOP reduction in OAG, ocular hypertension

2-year data in contralateral eye evaluation gives edge to iStent inject over Hydrus stent

Fluid dynamics in wet macular degeneration: How fluid type affects visual acuity

EURETINA leadership discusses what to expect at the 2022 Congress, outlines Women in Retina programme