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In a real-world study of patients with treatment-naïve and previously treated diabetic macular oedema, injection of intravitreal dexamethasone 0.7-mg implant provided effective disease control with initial and repeat injections, regardless of reinjection interval.

DMO study shows robust efficacy of intravitreal dexamethasone implant 

On 13 January, Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., announced it would partner with Klinge Biopharma GmbH and Formycon AG in commercialising FYB203, Formycon’s biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals Inc.) in designated regions of Europe.

 On 5 February, Formycon announced that Klinge Biopharma had also concluded an exclusive license agreement with Lotus Pharmaceutical.

 This new agreement will enable commercialisation of the product throughout the Asia-Pacific region. Pending regulatory approval, the product will be marketed under the brand name AHZANTIVE.

Under these agreements, Teva will lead the commercialisation effort in designated regions of Europe, excluding Italy, and in Israel. Lotus Pharmaceutical will lead commercialisation in Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam, as well as within the Special Administrative Region Hong Kong.

Previously, Teva was established as the European commercialisation partner of FYB201, Formycon's biosimilar to ranibizumab (Lucentis). Nicola Mikulcik, hief business officer of Formycon, commented on the expansion of the partnership. “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field,” she said in the press release.

 “We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.”

Like its reference product, the biosimilar FYB203 is an anti-vascular endothelial growth factor (VEGF) agent used to treat retinal disease. Chief among those indications is neovascular age-related macular degeneration (AMD), also known as wet AMD.

In November 2024, the European Medicines Agency's Committee for Medicinal Products of Human Use issued a positive recommendation for marketing authorisation of FYB203, under the brand names AHZANTIVE/Baiama. The European Commission is expected to announce a response to the authorisation application in late January 2025.

In June 2024, the US Food and Drug Administration (FDA) approved the biosimilar FYB203, also known as aflibercept-mrbb. In a press release at that time, the company stated3 that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that FYB203 demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference product in patients with neovascular AMD.

Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. News release. Teva Pharmaceutical Industries Ltd. Published January 13, 2025. Accessed January 13, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008103/0/en/Teva-Announces-Collaboration-to-Commercialize-Formycon-s-Biosimilar-Candidate-to-Eylea-aflibercept-in-major-parts-of-Europe-and-in-Israel.html

Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region. News release. Formycon AG. Published February 5, 2025. Accessed February 5, 2025.

Harp M. FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive). Ophthalmology Times. Published July 2, 2024. Accessed January 13, 2025. https://www.ophthalmologytimes.com/view/fda-approves-formycon-s-biosimilar-to-eylea-aflibercept-mrbb-ahzantive-

The commercialisation agreements for the biosimilar to aflibercept (Eylea) cover Israel, major parts of Europe and the Asia-Pacific Region

Teva partners with Klinge Biopharma, Lotus Pharmaceutical for commercialisation of Formycon’s FYB203 (biosimilar aflibercept)

Over the last 15 years, biosimilars have become a major feature of the health care landscape. Physicians in many disciplines, particularly oncology and immunology, have embraced biosimilars. However, access to educational resources on these powerful biologics can be inconsistent, and in turn, some ophthalmologists who could benefit from the adoption of biosimilars are left in the dark.

The real-world application of biosimilars was the focus of discussion for Martin Zinkernagel, MD, PhD, chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, and Paolo Lanzetta, MD, professor of ophthalmology and chairman of the Department of Medicine-Ophthalmology at the University of Udine in Italy. In their discussion, the experts addressed several common questions, framed around the phase 3 clinical trial for biosimilar SB11 (BYOOVIZ) from Biogen. SB11 is approved in Europe and the United Kingdom. Like the reference product ranibizumab (Lucentis), SB11 is approved for the treatment of retinal disease including neovascular age-related macular degeneration (nAMD).

Addressing physicians’ levels of familiarity with biosimilars, Dr Lanzetta attributed much of the variation to regulatory discrepancies. “The uptake of biosimilars varies throughout Europe by country and by product,” he said. “Obviously, variation in the uptake of biosimilars [is] influenced by government involvement, reimbursement issues and tender procurement policies.” Recent survey data have revealed gaps in awareness across Europe and in the United States on the efficacy and safety of biosimilars for retinal diseases, Dr Lanzetta said, especially in terms of “real-world data.”

In a clinical application, Dr Lanzetta said, biosimilars may exhibit minor differences from the reference products, but they aren’t considered to have significant impact on the efficacy or safety profile. Typically, the biosimilar and reference medicine must have the same posology and route of administration, with few exceptions, he added.

Dr Lanzetta also said that in the last 10 years, the European Medicines Agency (EMA) has approved the highest number of biosimilars worldwide.

 “And this means, to us physicians, having both the possibility to have experience on their use in terms of safety and evaluating the efficacy after that,” he explained.

One common misconception about biosimilars is that these therapeutics are interchangeable with the idea of generic medicines. But there is a key indicator that biosimilars are unique: the cost. “While generic medicines are marketed at a significantly lower price than name brand ones, why do we not see the same level of cost savings with biosimilars?” Dr Zinkernagel asked.

Dr Lanzetta explained that biosimilars are developed via a rigorous, complex and highly regulated manufacturing process. “Generics are simple chemical medicines or agents, which is not the case for biosimilars and biologics,” he said. “Unlike generics, biologics, and therefore biosimilars as well, are very complex; they’re very difficult to copy. And the development processes are patented and proprietary to the originators.” The proprietary nature of biologic development, he added, is why biosimilars may have differences from their originators.

Prof Zinkernagel and Dr Lanzetta used data from the SB11 phase 3 trial to expand upon the capabilities of biosimilars. Prof Zinkernagel detailed the study: over 700 patients were included in the randomised, double-masked, parallel-group multicentre trial. Over 52 weeks, investigators evaluated the efficacy and the safety profile of this biosimilar SB11 in comparison with monthly ranibizumab for the treatment of nAMD.

“Patients with neovascular AMD were included, [with a] visual acuity range between 20/40 and 20/200,” Prof Zinkernagel said. “[Patients] were randomised in a 1:1 ratio to either have the originator or the biosimilar every 4 weeks from baseline up to week 48.”

Primary end-points were change from baseline in best corrected visual acuity at week 8 and change from baseline in central subfield thickness at week 4. The pre-specified secondary efficacy end-points included longer-term assessments of change from baseline in visual acuity, and the proportion of participants who lost fewer than 15 letters or who gained 15 or more letters in visual acuity from baseline at weeks 24 and 52.

“Other secondary end-points included, of course, change from baseline in central subfield thickness and central retinal lesion thickness at week 24, as well as change from baseline in choroidal neovascularisation [CNV] size and proportion of participants with active CNV leakage seen via OCT [optical coherence tomography] at week 24,” Prof Zinkernagel continued. Describing the results, he said, “When you look at the visual acuity improvements, it’s really equivalent. You have equivalence between the originator and the biosimilar, and the same holds true for a decrease in central retinal thickness. So the curves are basically the same, and also the secondary end-points.”

Prof Zinkernagel also spoke about the immunogenicity outcomes of the SB11 trial, as immunogenicity reactions have been a common problem in past assessments of anti–vascular endothelial growth factor (VEGF) agents. Along with detrimental effects to visual acuity, immunogenicity reactions can also lead to vasculitis and vitritis.

“Now, in this trial, the overall cumulative incidence of anti-drug antibodies, antibodies reacting against this specific drug up to week 52, was very low,” Prof Zinkernagel said. “For the SB11 biosimilar, it was 4.2%, and for the originator it was 5.5%. So very, very similar.”

He also noted that most antibodies were non-neutralising, which generally indicates a weak antibody response. “Furthermore, no statistical or clinically relevant differences in the incidence of anti-drug antibodies and neutralising antibodies were observed between treatment groups at any of the time points,” Prof Zinkernagel explained.

Dr Lanzetta highlighted the unique potentialities for anti-VEGF therapies as an area where physicians can consider treating patients with a biosimilar. “You can either switch a patient from the originator, obviously, or you can also consider treating with a biosimilar treatment-naive patients who may benefit…from being treated with that reference agent or originator agent,” he said. When to deploy a biosimilar will depend on many factors, including the locality where a patient is being treated. “Europe has different countries, different health care systems,” Dr Lanzetta said. “You may consider treating with the biosimilar patients who may not be strictly adherent to the cost of therapy and the frequency of treatment because of some cost issues.”

Just as education on biosimilars is vital to practitioners, awareness and education resources for patients are vital, too. “We spend a lot of time with our patients in letting them know that biologics did undergo a very rigorous approval process through studies, efficacy and safety studies,” Dr Lanzetta emphasised. This education is vital to getting patients on board with biosimilars, and it sparks enthusiasm about the potential benefits. “Once they do understand that, I think they will be very prone to receive a biosimilar; [it’s] in their interest and in the interest of the community, the whole community of patients, and in the interest of the health care system,” Dr Lanzetta said.

1. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency. Updated December 2, 2019. Accessed October 3, 2023. 

https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pd

Editor’s note: A prior version of this article contained a misspelling of the product name BYOOVIZ. It has been corrected. We regret the error.

How biosimilars expand treatment options for patients with retinal disease

This article is dedicated to the memory of Ramin Tadayoni, MD, PhD.

Data from the Global Burden of Disease Study showed that in 2020, diabetic retinopathy (DR) ranked as the fifth most common cause of blindness and moderate and severe vision impairment among adults aged 50 years and older.

 Despite advances in medical/pharmacologic therapy for achieving systemic metabolic control and for managing diabetic eye disease, the burden of these consequences of DR may be expected to increase in association with population aging and as the prevalence of diabetes continues to rise.

Surgical intervention with vitrectomy is required for the management of some vision-threatening complications of proliferative DR, including tractional retinal detachment involving or threatening the fovea, persistent vitreous hemorrhage, mixed retinal detachment, and tractional diabetic macular edema. The surgical goals include relieving traction, removing fibrovascular proliferation and the posterior hyaloid, and ensuring retinal attachment with tamponade as needed. Determining the need and urgency for performing vitrectomy and achieving optimal functional and anatomical surgical outcomes depends on the ability to visualize the pathology. Developments in technologies for diagnostic imaging and surgical visualization enable clinicians to make informed decisions by visualizing pathology, and subsequently improving patient outcomes.

In addition to establishing the indication for surgery, findings on preoperative imaging are used for planning the procedure and have prognostic significance. Referral to preoperative images facilitates location of interventional targets, and there is accumulating evidence demonstrating that certain features in eyes with DR are predictors for risk of DR progression and visual outcome.

Color fundus photography (CFP) has been the mainstay for evaluating eyes with DR. However, the 7-standard ETDRS fields provide a limited field of view (75°) and fail to capture pathology existing in the peripheral retina, which has become of significant importance for predicting progression of DR.3 In addition, visualization of the fibrovascular proliferation and its extension beyond the mid-periphery is critical for planning surgery in eyes with tractional retinal detachment (Figure 1). Currently available dedicated widefield and ultra-widefield camera systems provide single capture FOVs beyond the 7-field ETDRS area offering acquisition efficiency, enhanced patient comfort, and view beyond the mid-periphery. The ZEISS CLARUS is one such UWF fundus camera with a FOV of 133° for a single image and up to 267° with ultra-wide field montage.

In addition to CFP, optical coherence tomography (OCT) is a cornerstone in the evaluation and management of diabetic eye disease. OCT provides high resolution images of retinal morphology and relevant DR lesions that makes it a valuable aid in establishing the need for medical or surgical intervention and procedure planning. The detailed OCT images can also allow detection of pathology that can be overlooked on the color fundus photographs, such as small retinal breaks or areas of fibrovascular proliferation. OCT biomarkers such as Disorganization of the Retinal Inner Layers (DRIL) are also important for determining visual prognosis and treatment response of patients with diabetic macular edema (DME).

When used together, quality images from CFP and OCT enable understanding of the extent of proliferation and the connection of the posterior hyaloid to new vessels. Surgically this is important to understand where to initiate opening in the posterior hyaloid face.

Used to assess retinal vasculature, fluorescein angiography (FA) has also been a key diagnostic tool for imaging eyes with DR, and its utility has expanded with the development of widefield and ultra-widefield technologies. Nevertheless, FA is an invasive technique that carries risks and is contraindicated in certain patients. Furthermore, FA has limited depth resolution, and obtaining good quality images depends on operator expertise.

OCT angiography (OCTA) is a noninvasive study that provides depth-resolved images of the retinal microvasculature without need for a highly trained operator. However, OCTA does not identify leakage, and so it serves as a complement to FA rather than an alternative. OCTA is especially important for visualizing changes to the foveal avascular zone (FAZ), retinal ischemia, and changes to the vascular density that are difficult to detect and quantify on FA (Figure 1). These OCTA biomarkers provide diagnostic, prognostic, and predictive information related to visual outcome, risk of progression, and response to treatment (intravitreal steroid or anti-VEGF).

Advances in intra-operative visualization

Obtaining maximal visualization intraoperatively is critical to the success of vitrectomy performed for complications of proliferative diabetic retinopathy (PDR). The utilization of a microscope-integrated intraoperative OCT (iOCT) is very crucial as it addresses this need by enhancing identification of existing pathology and allowing surgeons to operate with greater safety and precision near the retina.

Use of a heads-up three-dimensional (3D) digital viewing system, such as the ZEISS ARTEVO 800 or its successor, the ZEISS ARTEVO 850, also provides benefits when performing vitrectomy for complications of DR. The 3D digital visualization offers enhanced resolution, magnification, and depth of field, with the latter having particular value in cases where the fibrovascular proliferation is attached to the posterior pole. This technology also allows the operation to be performed with a lower light intensity that results in less glare for the surgeon and less risk of phototoxicity for the patient. Moreover, surgeons benefit from the ergonomic advantages of using a heads-up display.

The following cases involving patients with PDR illustrate how I use advanced imaging technologies to help me with diagnosis, surgical planning, and intraoperative decision-making.

A 29-year-old patient presented with significant vision loss in the left eye. On examination she was found to have 20/200 BCVA associated with tractional retinal detachment. The B scan OCT image showed vast fibrovascular proliferation along the arcade and traction on the macula. The patient was scheduled for surgery (Figure 2).

Case 1 Example

Case example 1: Surgical management of a patient with proliferative diabetic retinopathy.

iOCT was used to confirm the planned site for opening the posterior hyaloid, guided its removal from sites of attachment to the posterior pole and the midperiphery, and used to verify absence of residual hyaloid (Video 1).The intraoperative imaging also revealed new vessels attached to the fovea border that made careful dissection mandatory for optimizing functional results. With good visualization, I was able to complete the dissection without causing any intraoperative breaks and therefore avoid the need for tamponade.

A second case also involved a relatively young patient with type 1 diabetes found to have proliferation of new vessels primarily on the optic nerve head but also along the major vascular arcades. Earlier intravitreal injection of an anti-VEGF agent increased traction on the retina. Therefore, it was crucial to find the space between the retina and the proliferation for opening the posterior hyaloid and to remove the proliferation without inducing traction while minimizing the risk for causing a break. Using iOCT after completing the dissection of the new vessels allowed me to check the status of the macula and confirm absence of a break (Figure 3).


Quality pre-operative imaging is essential for determining the surgical indication and treatment plan in eyes with PDR. Precise analysis of the extension of the fibrovascular proliferations and of the attachment to the posterior hyaloid serves as a guide to surgical decision-making. In the same way, iOCT associated with a high-resolution digital microscope has a valuable role in the effectiveness and safety of these delicate surgeries where accurate identification of dissection planes and the absence of iatrogenic dehiscence is crucial for achieving success.

GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. 

Teo ZL, Tham YC, Yu M, et al. Global prevalence of diabetic retinopathy and projection of burden through 2045: Systematic review and meta-analysis. 

Silva PS, Cavallerano JD, Haddad NMN, et al. Peripheral lesions identified on ultrawide field imaging predict increased risk of diabetic retinopathy progression over 4 years. 

Joltikov KA, Sesi CA, de Castro VM, et al. 

Munk MR, Somfai GM, de Smet MD, et al. The role of intravitreal corticosteroids in the treatment of DME: Predictive OCT biomarkers. 

Vujosevic S, Cunha-Vaz J, Figueira, J, et al. Standardization of optical coherence tomography angiography imaging biomarkers in diabetic retinal disease. 

Prof. Aude Couturier is an ophthalmologist at hospital Lariboisière (AP-HP) in Paris. She is specialized in vitreoretinal surgery, treatment of retinal diseases and retinal imaging.

Diabetic Retinopathy ranked as the fifth most common cause of blindness among adults aged 50 and older in 2020 according to data from the Global Burden of Disease study. Aude Couturier, MD shares her experience of using advanced imaging technologies to optimize diagnosis and surgical management of her DR patients in our latest Case of the Month.

Optimizing diagnosis and surgical management of diabetic retinopathy using advanced imaging technologies 

The reduction in near and intermediate visual acuity (VA) associated with presbyopia presents particular functional challenges for commercial pilots whose work mandates the ability to see clearly at multiple distances from near to far and under a variety of conditions that can create glare and decrease contrast. Highlighting the importance of the impact of presbyopia on visual function for pilots are data indicating that airline pilots are a “graying” population with an average age of about 44 years among European pilots and even older among those in other global regions.

To achieve medical certification for flying, commercial airline pilots must meet rigorous visual performance standards, including for VA at all distances. ZEISS PRESBYOND

 (Carl Zeiss Meditec AG; Jena, Germany) is a binocular corneal approach to manage presbyopia that has the ability to successfully meet the complex visual demands of presbyopic pilots whether hyperopic

. Performed using a software option for the ZEISS CRS-Master

 90 excimer laser (all Carl Zeiss Meditec), ZEISS PRESBYOND increases depth of field by inducing a controlled amount of spherical aberration. The surgeon is correcting the dominant eye for far and the non-dominant eye for near, creating an anisometropia of up to 1.5 D, depending on the tolerance of the patient. The result is the creation of a blend zone that affords patients continuous vision over a range of distances. The small inter-eye difference in refraction that is present after ZEISS PRESBYOND is well-tolerated by most individuals and does not affect stereoacuity. Furthermore, because ZEISS PRESBYOND creates a continuous aspheric profile on the cornea rather than multifocality, patients maintain good contrast sensitivity and visual quality. As published in numerous peer reviewed journals, the clinical results achieved with ZEISS PRESBYOND in patients treated at our center and by other surgeons provide evidence that it is a safe, well-tolerated, effective method for treating presbyopia with high accuracy, stability, adjustability and, if needed, reversibility.

Since 2012, many commercial and military pilots have been treated with ZEISS PRESBYOND at our London Vision Clinic. One of the earliest individuals in this series was Eleanor Ivory, MD, who worked for British Airways as both a commercial airline pilot and Aeromedical Examiner (AME) whose job entails conducting examinations for granting pilot medical certification. Dr Ivory had worn contact lenses to correct myopia since her early teens. Wanting to explore vision correction options other than readers or varifocal glasses for achieving spectacle independence, Dr Ivory presented at age 53 to the London Vision Clinic in 2013. On assessment, her refraction was -3.50 -0.50 x 146 OD and -2.25 -0.75 x 10 OS, and she was deemed an appropriate candidate for a LASIK procedure. After counselling about the risks, benefits, and alternatives, Dr Ivory was treated using ZEISS PRESBYOND software with her dominant right eye targeted for far (plano refraction) and her left eye for near (-1.50 DS).

At 1 month after surgery, Dr Ivory’s binocular uncorrected VA was 20/16-1 at distance, J3 at intermediate, and J1 at near. She received Class 1 medical recertification without glasses restrictions from the United Kingdom Civil Aviation Authority at 8 weeks postop, and review of data collected at return visits over the next 8 years show that her refraction and binocular VA values were stable long-term. Moreover, at 10 years after surgery, Dr Ivory remains exuberant about her outcomes and an ardent advocate for ZEISS PRESBYOND.

Over the years, feedback from the numerous pilots treated with ZEISS PRESBYOND indicates that the recorded VA results correspond with improved ability to perform the full range of their occupational vision-related tasks. However, we wanted to formally document the subjective benefits of ZEISS PRESBYOND for pilots and approached Dr Ivory for help developing a questionnaire. After reviewing the presenting complaints and motivational factors expressed by pilots who had presented for laser refractive surgery assessment, Dr Ivory in collaboration with two other commercial airliner pilots designed a 16-item questionnaire.

The questionnaire asked pilots to rate their ability or comfort with tasks before surgery with glasses and after surgery without glasses. It was sent to 23 pilots who had undergone ZEISS PRESBYOND at least 12 months earlier and was completed by 18 pilots. All of the responding pilots received Class 1 medical recertification from the UK Civil Aviation Authority within 2 to 8 weeks after ZEISS PRESBYOND, which speaks to the speed of visual recovery after the surgery and the efficacy of the treatment. Notably, all pilots had binocular uncorrected VA of 20/20 or better at distance and J2 or better at near, and 17 of the 18 pilots achieved J5 or better binocular uncorrected intermediate VA. Eleven pilots (61%) achieved medical recertification without any spectacle requirement or restriction, and the others were recertified with a limitation indicating glasses, including a spare pair, shall be kept readily available in the cockpit if required. Notwithstanding the conditions of their certification, 15 of the 18 pilots (83.3%) reported being able to perform 100% of their vision-related tasks without glasses. In addition, analyses of the data collected in the questionnaire showed that the group achieved statistically significant improvements after surgery in their performance of various tasks as well as in eye comfort (Figure 1). An overall satisfaction score calculated from the data also improved, increasing from a mean of 3.32 ± 0.3 before surgery with glasses to 4.57 ± 0.20 after surgery without glasses, which is very close to the best possible score of 5.0.

ZEISS PRESBYOND is a safe, efficient, and effective LASIK-based procedure for providing spectacle-independence to presbyopic patients in the absence of cataract. Results from published studies world-wide show that ZEISS PRESBYOND delivers excellent vision at all distances without causing loss of contrast or dysphotopsia.

 In addition, patient-reported outcomes data show high levels of satisfaction, including among pilots who face complex visual demands within a challenging environment.

Knowledge that the results of ZEISS PRESBYOND satisfy pilots who represent a highly demanding group should give refractive surgeons confidence that this binocular LASIK-type procedure can be a great option to consider for the large and growing population of patients who do not yet have cataract and are interested in solutions for their presbyopia.

Reflections of an Aeromedical Examiner “laser eye surgery expert”

I began wearing contact lenses to correct myopia at age 14, and the desire not to wear glasses once I became presbyopic prompted me to research laser eye surgery as a solution to requiring reading glasses.

Undergoing PRESBYOND blended LASIK was a life-changing event for me. I was thrilled that after the surgery I was able to see clearly at all distances without glasses, and a decade later, I still have virtually perfect vision without correction.

Using varifocal glasses to manage presbyopia suits many pilots, but wearers of these aids can be challenged to find the right tilt of the head to look through the correct part of the glasses. In contrast, I experience no delay in accommodation between the various focal distances that pilots are required to rapidly transition through.

As clearly highlighted by the results of the pilot survey, freedom from requiring glasses after PRESBYOND has benefit for several routine flight deck tasks. Strikingly, the survey showed a particular impact in the RARE event where a pilot would have to don a flight oxygen mask or smoke hood. A benefit of PRESBYOND in terms of flight safety also became apparent to me after I had the procedure.

Because I personally underwent LASIK, I am considered “the laser eye surgery expert” in my role as an AME. When approached by pilots interested in refractive surgery for presbyopia, I tell them that PRESBYOND has been a miracle procedure for me, and I recommend it without any hesitation.

Dr Ivory has no relevant financial interests to disclose.

Statista. Average age of airline pilots in 2016, by region. https://www.statista.com/ statistics/739969/average-age-of-airline-pilots/#:~:text=Airline%20pilots%20in%20the%20Americas,average%20age%20of%2043.7%20years. Accessed September 25, 2023.

Russo A, Reinstein DZ, Filini O, et al. Visual and refractive outcomes following laser blended vision with non-linear aspheric micro-anisometropia (PRESBYOND) in myopic and hyperopic patients. J Refract Surg. 2022;38(5):288-297.

Reinstein DZ, Couch DG, Archer TJ. LASIK for hyperopic astigmatism and presbyopia using micromonovision with the Carl Zeiss Meditec MEL80 platform. J Refract Surg. 2009;25(1):37-58.

Reinstein DZ, Archer TJ, Gobbe M. LASIK for Myopic Astigmatism and presbyopia using onlinear aspheric micro-monovision with the Carl Zeiss Meditec MEL 80 platform. J Refract Surg. 2011;27(1):23-37.

Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for the correction of presbyopia in emmetropic patients using aspheric ablation profiles and a micro-monovision protocol with the Carl Zeiss Meditec MEL80 and VisuMax. J Refract Surg. 2012; 28:531-541.

Reinstein DZ, Ivory E, Chorley A, et al. PRESBYOND Laser Blended Vision LASIK in commercial and military pilots requiring class 1 medical certification. J Refract Surg. 2023;39(1):6-14.

Ganesh S, Brar S, Gautam M, Sriprakash K. Visual and refractive outcomes following laser blended vision using on-linear aspheric micro-monovision. J Refract Surg. 2020;36(5):300-307.

Professor Dan Z. Reinstein, MD MA(Cantab) FRCSC DABO FRCOphth FEBO

 is Medical Director of the London Vision Clinic, London, England. He is a consultant for Carl Zeiss Meditec AG (Jena, Germany) and has a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and has received financial support.

Commercial airline pilots work mandates the ability to see clearly at multiple distances from near to far under a variety of conditions. This Case of the Month highlights the impact of prespyopia on visual functions for pilots and that ZEISS PRESBYOND can be a great option to consider improving the ability to perform the full range of their occupational vision-related tasks with high patient satisfaction after surgery.

Spectacle independence for presbyopic patients: Achieving success and satisfaction with ZEISS PRESBYOND, even in a highly demanding cohort

I opened my own refractive surgery practice in Perth, Australia in 2019, and when getting started I was mostly performing LASIK in pre-presbyopic patients. Perth is the fourth largest city in Australia but is the most competitive regarding refractive surgery. For instance, the number of centers offering lenticule extraction surgery is greater in Perth than in Sydney and Melbourne combined. To set myself apart from other centers, I saw a potential for practice building by offering solutions for presbyopia in patients without cataract, as this is a huge patient group whose special needs are currently not addressed by all clinics. My theory proved to be correct because within a few years, the latter group became a significant segment of my practice, accounting for about 35% of the total share.

Like most surgeons in Australia, I was performing refractive lens replacements (RLR) with multifocal IOL implantation to manage presbyopic patients without cataract, despite the disadvantages and risks of that approach.1 I tried a multifocal corneal approach but stopped after 9 patients because the results were far below my and my patients’ expectations.

In June 2022 I traveled to London, UK, to take the London Vision Clinic’s Forefront Refractive surgery course led by Prof. Dan Z. Reinstein and Mr Glenn Carp. My primary purpose for attending the program was my interest in augmenting my surgical portfolio for corneal refractive surgery with Lenticule Extraction (LE). The course also covered PRESBYOND from ZEISS, a corneal solution for treating presbyopic patients that differed from anything I had known before. I was intrigued by Prof Reinstein’s description of the results and benefits of PRESBYOND® and saw it as a great opportunity to meet the needs of my younger presbyopic patients without cataract seeking spectacle independence and to expand my practice.

PRESBYOND® is a software for planning a customized binocular LASIK procedure to both manage presbyopia and correct refractive error. It increases the depth of field by inducing a controlled amount of spherical aberration and creating a micro-anisometropia (≤1.5 D), the latter being well-tolerated by most patients. Studies have shown that up to 97% of presbyopic patients tolerate the micro- anisometropia.2 PRESBYOND® gives patients a continuous range of quality vision from near to far, has the accuracy of a laser refractive procedure, and avoids the drawbacks that accompany other methods used for surgical management of presbyopia like glare and haloes at nighttime. Importantly, patients treated with PRESBYOND® maintain stereoacuity and contrast sensitivity.

I began performing PRESBYOND® in September 2022, and it did not take long before it proved itself to be a valuable addition to my surgical armamentarium. Not only did the outcomes I was achieving show me that by implementing PRESBYOND® I had made the right decision for my patients, but reviewing my surgical volumes and center’s revenues, I knew that I had also made a fantastic business decision for my practice.

I recently analyzed visual acuity outcomes for my first 41 PRESBYOND® cases that comprised a mix of myopic and hyperopic patients. Subjective reports showed most patients were spectacle independent. No patient needed reading glasses, although some patients said they benefited from wearing glasses at certain times, especially for night driving. No patient lost ≥2 lines CDVA and no one was unhappy.

The analysis of my caseload and case distribution data showed that my total surgical volume increased more than 41% comparing the same 9-month period (Sept – May) from before and after I implemented both PRESBYOND® and LE with SMILE® (Figure).

Although both PRESBYOND® and SMILE® contributed to the increase, PRESBYOND® was the primary driver, largely accounting for a more than doubling of my total presbyopic treatments, which went from 82 to 166. Furthermore, after introducing PRESBYOND®, treatment for presbyopia in patients without cataract came to represent a majority of my procedures, accounting for 51% of my steadily growing clinic volume. The number of RLR procedures I performed dropped drastically since PRESBYOND® has become my first choice for younger presbyopic patients without cataract. Now I only perform RLR in occasional cases when a specific patient is not suitable for a LASIK procedure.

Equipment, training and marketing – What it took to get started

When I returned from Prof Reinstein’s course, I sold my excimer laser and ordered both the MEL® 90 excimer laser and the VISUMAX® 800 femtosecond laser.

In addition to having the necessary equipment for PRESBYOND®, it is also very important for surgeons to prepare themselves and their staff and to adapt the clinic’s workflow accordingly. While waiting for the delivery of my new lasers, my staff and I worked tirelessly to prepare for successful PRESBYOND® implementation. Attending Prof Reinstein’s course was essential for giving me the necessary foundation. Then my staff and I watched and rewatched video course material, and my optometrist and I practiced to both perfect our specific refraction skills needed for PRESBYOND®, and to refine our counseling conversations for potential patients.

Surgeons who are performing LASIK will find that the learning curve for the procedure itself is very short, since it is basically a LASIK procedure. In my opinion, however, one must first have a thorough understanding of the theory and working principle of PRESBYOND® along with knowledge of the components of the screening evaluation and preoperative workup that are essential for proper patient selection and surgical planning. Most patients are suitable candidates for PRESBYOND®, and accurate preoperative measurements are critical for customized planning of the ablation that is best for all individuals.

It had been suggested to perform at least 50 LASIK procedures with the MEL 90 from ZEISS to achieve very good clinical outcomes with LASIK patients and if necessary fine tune nomograms before beginning to use the laser for PRESBYOND®. Because I was obtaining such predictably accurate outcomes with MEL® 90 for my LASIK patients, I was able to introduce PRESBYOND® within 1 month.

Initially, I was marketing PRESBYOND® to consumers and referring eye care practitioners quite extensively. I recommend that surgeons starting out with ZEISS PRESBYOND do the same to set their practice apart from others. I had articles and advertisements placed in local newspapers and held continuing professional development meetings for optometrists and general ophthalmologists. During those meetings I had patients share their experience because I thought their success stories would be more convincing than my lecturing. I also offered PRESBYOND® to optometrists and general practitioners, confident that these practitioners would become satisfied patients and a lifelong source of referrals. In fact, my practice benefits from a wide referral base, and is now the prime center in Perth for surgical management of presbyopia. My success with PRESBYOND® now draws patients to my practice through word-of-mouth referrals, and our need to advertise the procedure has significantly decreased.

Addressing the needs of presbyopic patients has definitely been one of the best decisions for my practice. However, as reflected by my surgical volume data, the real game changer has been the switch from my original RLR approach to the corneal approach with PRESBYOND® as my procedure of choice for this large pool of potential patients. The functional results I am achieving with PRESBYOND® speak for themselves in confirming that it is a safe and effective procedure for managing presbyopia in patients with myopia4, hyperopia5, and emmetropia2. Moreover, the dramatic effect that “word of mouth” referrals are having on my practice growth is testament to the high level of patient satisfaction.

The trust in my gut feeling and the commitment of my team certainly had important roles in leading me along the path to “Infinity and PRESBYOND®”. But, implementing PRESBYOND® and being successful also involves investment and effort. The MEL® 90 laser and refractive workplace station with the PRESBYOND software from ZEISS are requisite. In addition, the surgeon and staff must become well-versed in the principles of PRESBYOND®, components of the screening evaluation, preoperative work-up, and elements of proper patient education. In closing, I hope that my experience with PRESBYOND® might motivate its adoption by other surgeons because I firmly believe that just like me, they will find benefit both for themselves and their patients.

, MBChB is medical director and founder of the Crystal Eye and Laser Centre, Perth, Australia. He is a paid consultant to Carl Zeiss Meditec.

1. Alvarado-Villacorta R, Hernandez-Quintela E, De La Torre-Gonzalez E, Loza Munárriz C, Martinez- Zapata MJ. Surgical interventions for presbyopia (Protocol). Cochrane Database of Systematic Reviews. 2023, Issue 3. Art. No.: CD015711.

2. Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for the correction of presbyopia in emmetropic patients using aspheric ablation profiles and a micro-monovision protocol with the Carl Zeiss Meditec MEL80 and VisuMax. J Refract Surg. 2012; 28:531-541.

3. Brar S, Sute SS, Bagare SN, Ganesh S. Functional outcomes and reading speeds following PRESBYOND LBV using nonlinear aspheric ablation profiles combined with micro-monovision. J Ophthalmol. 2021;2021:2957443.

4. Reinstein DZ, Archer TJ, Gobbe M. LASIK for Myopic Astigmatism and presbyopia using onlinear aspheric micro-monovision with the Carl Zeiss Meditec MEL 80 platform. J Refract Surg. 2011;27(1):23-37.

5. Reinstein DZ, Couch DG, Archer TJ. LASIK for hyperopic astigmatism and presbyopia using micromonovision with the Carl Zeiss Meditec MEL80 platform. J Refract Surg. 2009;25(1):37-58.

Lourens van Zyl wanted to set himself apart in a highly competitive surrounding and saw a potential for practice building by offering solutions for presbyopia in patients without cataract. Within a few years this group became a significant segment of his practice in total share. ZEISS PRESBYOND was the game changer for a business success story.

Cheryl Guttman Krader; Reviewed by Dr Albert J. Augustin

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