Catch up with what Optometry Times®' shared this week:

Optometry news

Introduction to biosimilars for AMD

Advances in drug creation would reduce cost burden of treatment for patients.

By Euin Cheong, OD

As a low-vision specialist, I see hundreds of patients with age-related macular degeneration (AMD) each year. Patients with advanced AMD frequently experience the greatest difficulty with daily activities and have the most limited ability to interact with loved ones. As a result of its increasing prevalence, it is the most common diagnosis seen in low-vision clinics.

AMD is one of the leading causes of visual impairment in the US, with nearly 20 million individuals with early-stage AMD and 1.5 million individuals with late-stage AMD.¹ Not only is the prevalence high, but the cost of treatment is also very high.

The main treatment drugs for exudative age-related macular degeneration are Eylea, Lucentis, and Avastin alongside some novel drugs such as Vabysmo and Beovu. While the exact price may differ for each case, the high price tag is irrefutable. Eylea and Lucentis cost about $1800 per dose whereas Vabysmo may cost more than $2300.^2,3 For many patients, an injection is required every 4 to 6 weeks so it is easy to see how the costs can add up for patients and insurance companies.

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Ocuphire announced FDA acceptance of NDA for Nyxol for the reversal of mydriasis, sets PDUFA date

Phentolamine ophthalmic solution 0.75%, or Nyxol, receives a PDUFA date of September 28, 2023, for the indication of reversal of pharmacologically induced mydrasis.

By Emily Kaiser, Assistant Managing Editor

On February 13, Ocuphire Pharma announced that their New Drug Application (NDA) for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacolologically induced mydriasis (RM) has been accepted by the U.S. Food and Drug Administration (FDA). The company also shared that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.¹

“The FDA’s acceptance of the NDA submission and PDUFA date in late September for Nyxol sets the stage for an exciting 2023,” Mina Sooch, MBA, founder and CEO of Ocuphire Pharma, said in a press release. “We look forward to working closely with the FDA during the review process. If approved later this year, Nyxol eye drops will be the first prescription reversal drop available for patients in the US. In addition, we look forward to leveraging the synergies of this first NDA for Nyxol in potential supplementary NDAs for presbyopia and dim light vision disturbances indications in the future.”

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Future advances in glaucoma therapy

Medical and surgical technological advances show promise for future glaucoma management.

By Thomas A. Wong, OD, FNAP; Behrad Garmsiri; Wanyi Pan

Glaucoma is a progressive disease that results in damage to the retinal nerve fiber layer and ultimately can cause a measurable loss of functional vision. Because of the irreversible nature of the disease, end-stage glaucoma patients are frequently referred to low-vision services. The rate of glaucoma progression is variable and is generally considered to be correlated with a variety of risk factors.

While the etiology of glaucoma is not well understood, there are several treatment modalities aimed at decreasing intraocular pressure (IOP). Decades of research provide evidence that this is an effective method of mitigating the rate of glaucoma progression and vision loss. Currently, IOP is the only modifiable risk factor and lowering it the only effective strategy for treatment of the disease. The traditional IOP-lowering treatment involves the use of pharmaceutical agents that affect the aqueous outflow pathways and decrease the production of aqueous humor, or a combination of these effects.

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Digging into the 6-month first-in-human clinical trial data from SpyGlass Pharma

Patrick Mooney, CEO of SpyGlass Pharma, sits down to discuss the 6-month first-in-human clinical trial data of their drug delivery platform with bimatoprost, which is implanted during routine cataract surgery.

By Patrick Mooney; Emily Kaiser, Assistant Managing Editor

Emily Kaiser:

Hi, everyone, I'm Emily Kaiser with Optometry Times. SpyGlass recently released their 6-month data of their first-in human (FIH) clinical trial of a bimatoprost-eluting IOL. I'm here with Patrick Mooney, CEO of SpyGlass. Welcome. Thanks for taking the time to talk to me.

Patrick Mooney:
Hi, Emily. Thanks for the time. Happy to be here.

Kaiser:
All right. Well, what can you tell me about this new data from SpyGlass?

Mooney:
Sure. Just last Friday, as you kindly reported out, SpyGlass released an update to our first-in-human clinical trial at the 6-month time point; last year, we released the 3-month results. And as of last week, we released the updated 6-month results, which showed continued efficacy and safety of mean IOP reductions of 45% across all treatment groups. And these patients are still off of IOP-lowering therapy, and we're really happy to see it. So it was really encouraging and a strong signal that we're developing something really special here.

See the full interview

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Rigid gas permeable contact lens deposition measured via radiolabeled proteins

The Biosciences group of the Centre for Ocular Research and Education (CORE) determined protein deposits on rigid gas permeable contact lens via radioactive counts by using a radiolabeled lysozyme in an artificial tear solution.

By Emily Kaiser, Assistant Managing Editor

At the 2023 Global Specialty Lens Symposium, Centre for Ocular Research and Education’s (CORE) Biosciences group presented a scientific post on an investigation of protein deposits rigid gas permeable (RGP) contact lens deposition via a novel method: Incorporating radiolabeled lysozyme into an artificial tear solution, which allows researchers to determine on-lens protein through radioactive counts.¹

Investigators soaked 7 common RGP lens materials in the radioactive artificial tear solution for 16 hours, then exposed to a 3% one-step hydrogen peroxide (OSP) care solution for 8 hours to evaluate cleaning ability.

The deposits were minimal without use of a cleaning solution. The deposits ranged from 1.2 ± 0.2 μg to 3.2 ± 0.7 μg per RGP lens. After 30 alternating incubating and cleaning cycles with OSP solution, the amount of radioactive lysozyme on the RGP lenses reduced significantly when compared to using phosphate buffered saline. With the OSP solution, the remaining lysozyme on cleaned lenses ranged from 1.3 ± 0.1 μg to 2.5 ± 0.1 μg per lens.

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Harrow, ImprimisRx launch compounded atropine formulation

The next-generation compound of atropine does not contain preservatives or boric acid and can be stored at room temperature for up to 180 days.

By Emily Kaiser, Assistant Managing Editor

On February 15, Harrow announced the launch of its next-generation compounded atropine formulations, which do not contain preservatives or boric acid. Additionally, the new formulations have a physiologic pH of 5.5 and may be stored at room temperature for up to 180 days. The patent-pending formulations are now available through ImprimisRx, Harrow’s wholly owned compounding and mail order pharmacy subsidiary.

“Our mission has always been to help our eyecare professionals address their patients’ unmet needs and to make ophthalmic medications both accessible and affordable,” Mark L. Baum, Chairman and CEO of Harrow, said in a press release. “The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer.”

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Study shows positive improvement on combined treatment for wet AMD

OPT-302 combined with ranibizumab: covering all the VEGF bases for superior visual gains compared with ranibizumab alone in wet AMD.

By Lynda Charters

A phase 2b study¹ of OPT-302 (Opthea Ltd.), an anti-vascular endothelial growth factor (VEGF)-C/-D “trap” agent, in combination with ranibizumab (Lucentis, Genentech Inc.) to treat wet age-related macular degeneration (AMD) showed that administering the 2 VEGF inhibits drugs resulted in a larger improvement in visual acuity (VA) after 24 weeks compared with ranibizumab alone.

The rationale behind this treatment was to also inhibit VEGF-C and VEGF-D using OPR-302 in addition to VEGF-A, which ranibizumab, the standard of care for wet AMD, inhibits.

See the full study results

Practical management EP 4: Online promotions

In this episode of a practice management series with Maria Sampalis, OD, learn about different online promotions and how to put them into practice.

By Maria Sampalis, OD; Kassi Jackson, Editor

Jackson:

Once you have your branding base and initial steps in place, what kind of promotions can you do online through social media through the web, etc.?

Sampalis:

There's a lot of different things you can do.

I mean, just even putting images out there on your Facebook page, you know, 20% off second pair glasses, or marketing eblasts through your own network, or Facebook posts. And even Google is a great way to add AdWords. You could pay to advertise them every time someone clicks on a you know, that you get charged for.

And it's the most effective, easy way, because patients that are looking for a doctor will search Google for a new doctor, but also check your reviews. So that's important, too.

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Don’t let your patients fall behind: The future of AMD care

The eye care community is moving toward a more disruption-resistant system of care, from wearable tech to VEGF-eluting implants.

By Gregory Caldwell, OD, FAAO

In September 2022, researchers in Spain¹ released results of a 270-eye study of patients with age-related macular degeneration (AMD) and the effects they experienced following the COVID-19 pandemic lockdowns and related social disruptions in 2020 and 2021. Not surprisingly, these patients were found to have suffered an increased rate of visual loss beyond what would be expected in normal times, but worse, that loss was not fully recoverable when the lockdowns ended and regular AMD treatments resumed.²

This research data align with our common-sense understanding that any delay in the diagnosis or treatment of a progressive disease will likely be bad for the patient. In this light, it is every eye care provider’s duty to help implement a care system that is robust, resilient, and flexible enough to endure fast-moving and long-term calamities, whether local, regional, or global.

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IKA Keratoconus Symposium 2023: Sneak peek with Dr Szczotka-Flynn

Loretta Szczotka-Flynn, OD, PhD, sits down to discuss the International Keratoconus Academy's first annual keratoconus symposium, which will be held April 22-23, 2023, in Scottsdale, Arizona.

By Loretta Szczotka-Flynn, OD, PhD; Kassi Jackson, Editor

Jackson:

Why should practitioners be excited about this first meeting of the International Keratoconus Academy?

Szczotka:

I think this is the first meeting of its kind. It's kind of been a dream for a bunch of the meeting organizers to kind of put something like this together. I've been involved in the treatment and management of keratoconus patients for over 30 years. I remember one other meeting that I attended—[a] mixture of optometry and ophthalmology and basic scientists and all those people together—probably about 25 years ago. A very small meeting and we kept it just internal.

So this is really the first meeting really since then that we can get those same, you know, quality of presenters together. But it's going to be presented to a large variety of audiences at the same time. So I know it's going to be part virtual and part in-person.

Watch the full interview