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.® Dr. Patricia Piers, head of R&D, Ophthalmic Implants at Johnson & Johnson Surgical Vision, recently received the 2022 Women in Ophthalmology Scientific Contribution Award. This award recognizes a physician or non-physician scientist who has made significant contribution in the field of ophthalmology. Thank you for joining us today. Can you tell us a little bit about some of the contributions you made to ophthalmology that have led to this recognition?

 Thank you for the question. Yeah, I've been involved in, in as many as 20 new product launches. There are always several that stand out. Twice, I've been lucky enough to work on IOLs that were the first in the category. And, you know, the first of this was actually the very first project that I got to work on as a new employee. And that was the Tecnis lens, that that was the first ashperic lens on the market. Last year, 2021, was the 20th anniversary of the Tecnis IOL. So I guess that kind of dates me a little bit, tells you how long I've been working here. But in that, that lens actually evolved into the platform that we have today, that delivers high quality of vision, due to its design, and its unique materials. And all of the lenses in the Tecnis family of products are built on that platform that we created 20 years ago.

The second category creator that I got to work on was the Tecnis Symfony lens, which was the first of its kind, extended depth of focus lens, that that was also really special. As we were part of the creation of a category it with that one of lenses for presbyopia correcting. You know, like with anything else, it's always the ones that that you have to fight the hardest for, that are the ones that that you're most proud of.

In discussions of products that I'm most proud of the one that immediately springs to mind is the is a is one of our current, most current, most innovative products. That's the Tecnis Eyhance IOL that slightly extends the depth of focus for patients in the reimburse category. You know, it's, it's strange to say that I worked on these right, because as you know, I'm not responsible for anything alone, right? That that would definitely not be fair to say. Science is very rarely done, alone. And I'm really blessed to work with very special group of scientists and engineers. And actually, that's probably the thing that I'm most proud of is the group of really extremely competent, talented individuals that that I get to work with every day. So that's it.

 What does this recognition mean to you?

 I feel tremendously honored to represent Johnson and Johnson Vision, leadership in R&D and Surgical Vision. And especially with the WIO, this is a very special group that's extremely welcoming. And really setting the example of women helping women lead. I got the privilege of presenting this award to last year's winner and she was such an impressive individual that I don't really feel like I'm remotely in the same league. I'm excited to leave any imprint within Women in Ophthalmology that I can, as we really work together, to pave the way for more women in ophthalmology as well as STEM and supporting women in underrepresented areas of science and technology, which I'm also extremely passionate about.

 Looking to what's going on right now, what are some of the latest developments going on that you're seeing that will impact ophthalmology?

 Okay, so, what's going on in ophthalmology? It's, it's actually the best thing about this field, right? As a scientist and innovator, it's it, it's a field that truly gets completely under your skin because innovation moves very, at a very, very fast pace in this industry. You know, 2021 was a very exciting year for J&J Surgical Vision where we launched two very exciting products in the US market, the Tecnis Synergy IOL, a high-performance hybrid lens that's designed for spectacle, independence, and the Tecnis Eyhance IOL, that slightly extends the depth of focus for those patients in the monofocal category. And this year, J&J vision announced the Tecnis Symfony, OptiBlue IOL, the extended depth of focus lens that expands presbyopia correction to more patients and includes the InteliLight technology.

 What can these lenses, how can they help ophthalmologists provide better outcomes for their patients?

 Yeah, you know, as we as we go through new editions of technology, what we're what we're really looking for, is higher is higher quality of vision. And, you know, there's always a balance in everything we do, between providing a range of vision, providing a high quality of vision and providing reduced symptoms. And so as we as we continue to innovate in presbyopia correcting lenses, what we're looking for, is really a better balance. The Tecnis Symfony, OptiBlue, what we what we've provided with that lens is actually looking forward to the best contrast and low light performance in the presbyopia-correcting IOL category. So, every time we're innovating, we're striking a better and better balance between those three things, especially in the presbyopia correcting category that helps surgeons when we're reducing symptoms, it helps them to have to deal with less chair time, have less complaints from patients. Higher contrast vision is making patients safer. And having a larger range of motion is providing them with increased spectacle independence, or enabling them to do things that they otherwise wouldn't be able to do without spectacles.

 You mentioned having a great 2021. Are we still seeing any residual impacts from the pandemic on research and development?

 Yeah, we are. And you know, most of it comes from comes from what is trickling down from what we see with the in areas of the supply chain issues that we see worldwide, you know, that that affects us also on the front end of innovation as well. So, I think that's mostly where we're, we're seeing the effects, at least in industry. That as well as talent and staffing. And making sure that that you're able to, to work with the best possible people and it's really taking a lot more time to ensure that you're getting the same caliber of scientists and engineers that you really want to drive innovation forward.

 Are we seeing artificial intelligence being integrated into research and development efforts?

 Yes, definitely. It's being integrated in many, many areas. It's being integrated in diagnosis, it's being integrated in calculations, it's being integrated in design … all throughout the process. I's not taking, taking away from what people need to do, but it's making our lives easier.

 And looking forward. What's your outlook for research and development efforts in ophthalmology in 2023? And beyond?

 Oh, gosh, you know, there's just so much to be done, right. Billions of people during their lifetimes will have eye health needs. And the numbers are increasing every year. We all have our work cut out for us to raise the standards of care and improve outcomes for all those patients, as well as improving accessibility to care and improve solutions for all. And in cataract R&D, we're faced with aging populations and increased comorbidities. These are really exciting problems to work on. As I described earlier, we'll continue to develop new IOLs that will continue to improve and evolve and allow patients to have better outcomes and range of vision. The other thing, bringing it back to Women and Ophthalmology, as a member and advocate for Women in Ophthalmology, we continue to strive to elevate women and I think diversity in ophthalmology in R&D. This is through the actions of things like sponsorships and speaking engagements and clinical trials and R&D engagements to ensure that we really have a diverse group of people helping to solve all these problems that we, that I that I just mentioned. In order to ensure that we are providing the best solutions.

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In a two-decade career as a researcher at Johnson & Johnson Surgical Vision, Piers has been a part of teams at the forefront of a number of innovations in IOLs. She discusses her career and the outlook for research and development in ophthalmology. 

Patricia Piers, PhD, discusses a career of innovation in ophthalmology, looks to future

Alcon has finalized its acquisition of Aerie Pharmaceuticals.

Alcon today announced that it has completed its acquisition of Aerie Pharmaceuticals Inc. in a deal that will bolster the company’s presence in the ophthalmic pharmaceutical space with its growing portfolio of commercial products and development pipeline.

Through the transaction, Alcon has added the commercial products netarsudil and latanoprost ophthalmic solution 0.02%/0.005% (Rocklatan) and netarsudil ophthalmic solution) 0.02%, (Rhopressa

 as well as AR-15512, a Phase 3 product candidate for dry eye disease. Alcon has also acquired a pipeline of ophthalmic pharmaceutical product candidates with the opportunity to leverage Aerie’s existing research and development capabilities.

“As we welcome the Aerie team to Alcon, we look forward to leveraging our expanding commercial footprint and expertise to bring Rocklatan and Rhopressa to even more customers and their patients,” said David Endicott, CEO of Alcon. “Alcon has a rich history in the ophthalmic pharmaceutical space rooted in a deep understanding of Eye Care Professionals. We are excited to add Aerie’s significant technical expertise to Alcon R&D, which enhances our efforts to build a compelling portfolio of ophthalmic pharmaceuticals.”

The transaction also complements Alcon’s expansion into the ophthalmic pharmaceutical space, including acquisitions of the exclusive U.S. commercialization rights for Simbrinza from Novartis in April 2021 and Eysuvis and Inveltys from Kala Pharmaceuticals, Inc. in May 2022.

Alcon intends to fully integrate Aerie into its business. As previously disclosed, the company has used debt to fund the transaction for a total purchase consideration of approximately $930 million.

J.P. Morgan acted as Alcon’s financial advisor for the transaction, and Alcon’s legal advisor was Skadden, Arps, Slate, Meagher & Flom LLP. Goldman Sachs & Co. LLC and Lazard acted as Aerie’s financial advisors for the transaction, and Aerie’s legal advisor was Fried, Frank, Harris, Shriver & Jacobson LLP.

Ophthalmology Drugs Global Market Report 2021: COVID-19 Impact and Recovery to 2030.

Articles

The deal adds pharmaceutical research and development capabilities and further expertise for future product pipeline. It also expands Alcon’s presence in the $20 billion global ophthalmic pharmaceutical category. 

Alcon completes acquisition of Aerie Pharmaceuticals

Oculis SA has published positive data of its licaminlimab active-controlled, multicenter, randomized, parallel-group Phase 2 clinical trial (NCT02482129) assessing the effect of topical licaminlimab (OCS-02) on anterior chamber (AC) cell grade in patients with acute anterior uveitis (AAU).

The study is titled Topical Ocular Anti-TNFα Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study.

The study met its primary objective according to prospectively specified criteria, in the treatment of patients with AAU, and thereby established evidence of treatment effect. 

The data showed a response rate on Day 15 of 56% for licaminlimab-treated patients, defined as a reduction from baseline in AC cell grade of ≥2 (SUN).

Secondary and exploratory endpoints in the study were also supportive of the treatment effect of licaminlimab (OCS-02) eye drops, with most patients demonstrating a reduction of ≥2 units from baseline in AC cell grade by day eight, with few patients requiring rescue therapy, most patients achieving an AC cell grade of zero in at least one visit, and the median change from baseline in AC cell grade being equivalent to responder status. Licaminlimab (OCS-02) was observed to be well tolerated, including no increase in intra-ocular pressure related to licaminlimab (OCS-02).

Anat Galor, MD, professor of ophthalmology at the University of Miami Health System, pointed out that there is a need for 

non-steroidal anti-inflammatory therapies for

“This is particularly important for patients who require longer-term anti-inflammatory treatment given that long-term steroid treatment is not optimal due to the associated side effect profile,” Galor, said. “The positive results

demonstrate the potential of OCS-02 as a topical, non-steroidal therapy for

uveitis and have been crucial to inform the planned clinical trials for OCS-02 as a steroid-sparing treatment for patients with recurring or chronic

uveitis, where its unique profile may offer the greatest benefit to patients.”

Riad Sherif, MD, CEO of Oculis, lauded the results.

“These positive data further strengthen the potential of

to become the first topical biologic to treat anterior uveitis,

patients and physicians around the globe with a non-steroidal option,

an area of high medical need,” Sherif said in the news release.

Oculis is currently planning the start of

to further assess the potential of this novel product candidate in chronic anterior uveitis but also, in DED, another inflammatory condition,

provide a new option to doctors to treat their

Licaminlimab (OCS-02) is an anti-TNFα antibody product candidate based on an innovative antibody fragment technology allowing it to be administered topically. Its dual mechanism of action (MoA), anti-inflammation and anti-necrosis, is clinically proven with other anti-TNFα antibodies already approved as systemic treatment for ocular diseases and with transformative impact in other therapeutic areas.

If approved, licaminlimab (OCS-02) has the potential to become the first topical anti-TNFα to be approved for treatment of non-infectious anterior uveitis, and could help address the significant medical need for a steroid-sparing agent and for a topical biologic to be indicated specifically for non-infectious anterior uveitis without the associated systemic risks.

Phase 2b clinical trials of licaminlimab (OCS-02) for the treatment of non-infectious anterior uveitis, as well as dry eye disease (DED), are currently being planned by Oculis.

1. Theodore A. Pasquali, Melissa M. Toyos, David B. Abrams, David K. Scales, John W. Seaman, III, and Georges Weissgerber. Topical Ocular Anti-TNFα Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study. 

 June 2022; 11(6): 14. Published online June 15, 2022. doi: 

Oculis SA has published positive data of its licaminlimab active-controlled, multicenter, randomized, parallel-group Phase 2 clinical trial assessing the effect of topical licaminlimab on anterior chamber (AC) cell grade in patients with acute anterior uveitis.  

Oculis highlights positive phase 2 data investigating topical anti-TNFα agent licaminlimab in acute anterior uveitis

Re-Vana's proprietary technology platforms offer significant potential to deliver both novel and approved biologics for at least 6 months in the clinic, reducing the need for frequent intravitreal injections and extending therapeutic efficacy in the treatment of major eye diseases

Re-Vana Therapeutics Ltd. today announced the closure of its Series A round with $11.9 million in funding, an oversubscription of $4 million. The financing was led by Visionary Ventures.

According to a news release, additional investors include ExSight Ventures, InFocus Capital Partners and current UK investors Quibis Ltd, Co-Fund NI and TechStart Ventures.

The proceeds will advance the development of Re-Vana's novel and proprietary photo-crosslinked EyeLief, EyeLief-SD and OcuLie® biodegradable drug delivery technologies and will enable expansion of the company's operations and development teams.

With the successful completion of key nonclinical ocular safety, tolerability and efficacy studies, Re-Vana has demonstrated that its platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically-relevant levels with high drug loading, controlled burst release, and a favorable degradation profile.

According to the company, its platform has the potential to enable sustained drug delivery via non-surgical administration in office-based settings to treat ocular disease, overcoming several long-standing limitations and challenges in the field.

In conjunction with this financing, Re-Vana's board of directors has been further strengthened by the appointments of Robert Avery, MD, of Visionary Ventures and InFocus Capital Partners, as board member, and Michael O'Rourke, President and CEO of Re-Vana Therapeutics, as Board Chairman.

"Financing from new and existing investors during this challenging time is a testament to the potential of Re-Vana's technologies for sustained delivery of biologic therapeutics," O'Rourke said in the news release. "We are especially fortunate to have received follow-on financing from multiple, highly respected, US ophthalmic-focused venture capital firms and UK investors. Their proven knowledge and expertise in ophthalmology are invaluable additions to Re-Vana as we accelerate the development of our pipeline and expand our strategic partnerships."

"Re-Vana's proprietary technology platforms offer significant potential to deliver both novel and approved biologics for at least 6 months in the clinic, reducing the need for frequent intravitreal injections and extending therapeutic efficacy in the treatment of major eye diseases," Avery pointed out..

Re-Vana is a technology spin-out from Queen's University, located in Belfast, Northern Ireland. The company is currently developing sustained release ophthalmic therapeutics aimed at reducing the frequency of intravitreal injections required to treat a wide range of retinal diseases, including neovascular age-related macular degeneration (wet AMD). In addition, Re-Vana's proprietary photo-crosslinked sustained-release technology may enable the development of a broad range of novel, sustained release products applicable to a variety of therapeutic areas.

Re-Vana has demonstrated that its platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically-relevant levels with high drug loading, controlled burst release, and a favorable degradation profile. 

Re-Vana Therapeutics raises $11.9 million in Series A financing for development of ophthalmic therapeutics

Harrow and iOR Partners today jointly announced the expansion of their national product supply agreement to provide Harrow’s entire formulary compounded ophthalmic products to iOR Partners’ expanding office-based surgery locations across the United States.

In a news release, Mark L. Baum, chairman and CEO of Harrow, the company is pleased to be partnering with iOR Partners as they mobilize an increasing number of cataract surgeons to perform surgery in an office-based environment, offering more personalized care in a patient-friendly setting.

“iOR Partners assists practices nationwide to make office-based ophthalmic surgery a reality,” he said in a statement. Our mission has always focused on making medications accessible and affordable, and working with iOR Partners, the national leader in this fast-growing area of ophthalmic surgery, represents an important and growing channel for Harrow to meet our mission.”

“Harrow, through its ImprimisRx division, is the gold standard in supplying innovative compounded ophthalmic formulations that meet the highest federal manufacturing standards. Their commitment to quality, exceptional customer service, and the breadth of their portfolio are why we chose them as our partner,” Tony Burns, founder and principal of iOR Partners, said in the release. “These qualities support our confidence that we are delivering on our promise of personalized care that’s safe and comfortable for patients.”

“One excellent example of a product we find compelling is the MKO Melt, which has allowed us to substantially reduce the use of opioids and needles during office-based surgical procedures,” Burns added in the statement. “As we continue to grow and assist cataract surgeons with their vision of providing office‑based cataract surgery, we look forward to collaborating to further expand our services.”

The deal will provide Harrow’s entire formulary compounded ophthalmic products to iOR Partners’ expanding office-based surgery locations across the United States.

Harrow and iOR Partners expand national product supply agreement 

When the UCI-led team investigated the optic nerve head of eyes treated with mild pressure elevation, they noted that in the young optic nerve head, there was no sign of loss of axons. However, in the optic nerves of old animals, significant sectorial loss of axons was observed similar to the phenotype commonly observed in glaucoma patients. (

Investigators at the University of California, Irvine, have conducted research suggesting that aging is a key component of retinal ganglion cell death in glaucoma, and that novel pathways can be targeted when designing new treatments for glaucoma patients.

According to the study, titled “Stress induced aging in mouse eye,” Dorota Skowronska-Krawczky, PhD, assistant professor in the Departments of Physiology & Biophysics and Ophthalmology and the faculty of the Center for Translational Vision Research at the UCI School of Medicine, describes the transcriptional and epigenetic changes happening in aging retina.

According to a UC-Irvine news release, the team shows how stress, such as IOPelevation in the eye, causes retinal tissue to undergo epigenetic and transcriptional changes similar to natural aging. And, how in young retinal tissue, repetitive stress induces features of accelerated aging including the accelerated epigenetic age.

Aging is a universal process that affects all cells in an organism. In the eye, it is a major risk factor for a group of neuropathies called glaucoma. Because of the increase in aging populations worldwide, current estimates show that the number of people with glaucoma (aged 40-80) will increase to over 110 million in 2040.

“Our work emphasizes the importance of early diagnosis and prevention as well as age-specific management of age-related diseases, including glaucoma,” Skowronska-Krawczyk said in the news release. “The epigenetic changes we observed suggest that changes on the chromatin level are acquired in an accumulative way, following several instances of stress. This provides us with a window of opportunity for the prevention of vision loss, if and when the disease is recognized early.

Moreover, the investigators noted that in humans, IOP has a circadian rhythm. In healthy individuals, it oscillates typically in the 12-21 mmHg range and tends to be highest in approximately two thirds of individuals during the nocturnal period. Due to IOP fluctuations, a single IOP measurement is often insufficient to characterize the real pathology and risk of disease progression in glaucoma patients. Long-term IOP fluctuation has been reported to be a strong predictor for glaucoma progression. This new study suggests that the cumulative impact of the fluctuations of IOP is directly responsible for the aging of the tissue.

“Our work shows that even moderate hydrostatic IOP elevation results in retinal ganglion cell loss and corresponding visual defects when performed on aged animals,” Skowronska-Krawczyk added in the news release. “We are continuing to work to understand the mechanism of accumulative changes in aging in order to find potential targets for therapeutics. We are also testing different approaches to prevent the accelerated aging process resulting from stress.”

Researchers now have a new tool to estimate the impact of stress and treatment on the aging status of retinal tissue, which has made these new discoveries possible. In collaboration with the Clock Foundation and Steve Horvath, PhD, from 

, who pioneered the development of epigenetic clocks that can measure age based on methylation changes in the DNA of tissues, it was possible for researchers to show that repetitive, mild IOP elevation can accelerate epigenetic age of the tissues.

“In addition to measuring vision decline and some structural changes due to stress and potential treatment, we can now measure the epigenetic age of retinal tissue and use it to find the optimal strategy to prevent vision loss in aging,” Skowronska-Krawczyk explained.

According to the university news release, this research was funded in part by the National Institutes of Health, the Foundation for Polish Science and the European Union under the European Regional Development Fund. Authors would like to acknowledge support of the Research to Prevent Blindness Foundation for Department of Ophthalmology at UCI.

1 Qianlan Xu, Cezary Rydz, Viet Anh Nguyen Huu, Lorena Rocha, Claudia Paomino L Torre, Irene Lee, William Cjo, Mary Jabari, John Donello, David C. Lyon, Robert T. Brooke, Dorota Skowronska-Krawczky, PhD, et.al. “Stress induced aging in mouse eye.” Aging Cell. Published November 18, 2022. DOI: 10.1111/acel.13737

According to investigators, retinal aging caused by stress produces symptoms similar to those resulting from natural aging.