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Heidelberg Engineering: Enhancing the Patient Journey

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Closing out his discussion on the port delivery system in retinal diseases, Chirag Jhaveri, MD, considers how this approach has impacted the treatment landscape. 

Clinical Implications of Port Delivery System in Retinal Diseases

Concise insight on education and training strategies that will optimize use of the port delivery system in retinal diseases.

PDS in Retinal Diseases: Practical Advice on Education and Training 

Chirag Jhaveri, MD, reviews the trial design and results of the LADDER and ARCHWAY studies, which tested the port delivery system in neovascular AMD. 

PDS in Retinal Diseases: Interpreting the LADDER and ARCHWAY Studies

Expert insight on the history of the port delivery system in neovascular AMD and how it has impacted patient experience and outcomes.

The Development and Safety of Port Delivery System in Retinal Diseases 

The European Commission provided a positive opinion from the European Medicines Agency (EMA) Committee for Advanced Therapies, providing an Advanced Therapy Medicinal Product (ATMP) classification to OCU400 (Ocugen, Inc.). OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication.

ATMP classification is given to medicines that allow for innovative opportunities for the treatment of disease, thus accelerating the regulatory review timeline of the new gene therapy. The classification will also allow for further collaboration between Ocugen and the EMA, with the EMA in place for scientific advice and protocol assistance as the company pushes for Marketing Authorisation Application (MAA) filing in 2026.

“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Shankar Musunuri, chairman, CEO and co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States and Europe by 2027.”

Besides the EMA, the FDA has also acknowledged that the Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA) and MAA submissions. Ocugen, Inc. plans to file simultaneously in the US and Europe after completion of the trial.

Currently, the Phase 3 OCU400 trial is undergoing enrollment, and the study has a sample size of 150 participants. Patients 8 years old and older with early through late-stage advancement of RP are being recruited to take part in the study.

“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” Huma Qamar, chief medical officer at Ocugen, said. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”

Ocugen Announces Positive Opinion of European Medicines Agency’s Committee for Advance Therapies for Advanced Therapy Medicinal Product Classification for Modifier Gene Therapy Candidate OCU400 for Retinitis Pigmentosa. News release. Ocugen. Published February 3, 2025. Accessed February 3, 2025. https://www.globenewswire.com/news-release/2025/02/03/3019337/0/en/Ocugen-Announces-Positive-Opinion-of-European-Medicines-Agency-s-Committee-for-Advanced-Therapies-for-Advanced-Therapy-Medicinal-Product-Classification-for-Modifier-Gene-Therapy-Ca.html

OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication

Ocugen, Inc. receives European Medicines Agency ATMP designation for new gene therapy OCU400

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

Formycon AG announced that the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis (ranibizumab, Genentech Inc.). FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Along with the regulatory decision, Formycon announced it has established a commercialisation partnership with the Brazilian pharmaceutical company Biomm. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars.

Biomm's product launch of FYB201 is expected to occur in the fourth quarter of 2025, marking the beginning of a phased market rollout of FYB201 across Latin America. The regional regulatory authorities in Peru, El Salvador, Honduras and the Dominican Republic have already granted marketing authorisations for the biologic drug. Further approvals and product launches in Central and South America are planned through early 2027, according to the press release issued by Formycon.

Formycon Chief Business Officer Nicola Mikulcik stated, "The marketing approval of FYB201/Ranivisio in Brazil underlines our mission to improve access to high-quality biologic drug therapies, especially in countries where the use of high-cost biologics is quite limited today. We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil.”

FYB201 is used to treat severe visual impairments such as wet age-related macular degeneration and other retinopathies. The biosimilar is currently available in a total of 21 countries in Europe, North America, the Middle East and North Africa.

1. Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil. Press release. Formycon AG. Published June 5, 2025. Accessed June 5, 2025. https://www.formycon.com/blog/press-release/lucentis-biosimilar-fyb201-ranivisio-ranibizumab-in-brasilien-zugelassen/

Brazilian ANVISA has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis.

Brazil’s ANVISA grants marketing authorisation to Lucentis biosimilar FYB201 (Ranivisio, Formycon/Bioeq AG)

Heidelberg Engineering announced its 2025 International SPECTRALIS Symposium (ISS) will be held in Heidelberg, Germany, from 13 to 14 June. This year marks the 21st anniversary of the ISS, and the event will be the first ISS held in the newly-opened Heidelberg Congress Center, the company said in a press release.

The keynote presentation will be given by Warren Hoburg and Tyson Brunstetter, OD, PhD, astronauts at the US-based National Aeronautics and Space Administration.

Frank Holz, MD, FEBO, FARVO, professor and chair of the Department of Ophthalmology at University of Bonn, Germany, will serve as chair for the symposium. Over the course of 2 days, attendees will be able to hear from 35 different speakers, traveling to Heidelberg from across 12 countries.

“What began 21 years ago as a dedicated retinal imaging event has evolved into a comprehensive platform for innovation in ophthalmology,” Prof Holz said in the press release. “The opportunity to engage with such a distinguished group of experts and discuss emerging therapies in this setting is truly unparalleled.

 includes seven different sessions over the course of the symposium, with multiple lectures on each topic: oculomics, High-resolution optical coherence tomography (OCT), new technology, age-related macular degeneration and geographic atrophy, artificial intelligence, retina and distributed care. The keynote session on Friday, 13 June will be presented in conjunction with NASA and is titled "A journey into space." 

Researchers use Heidelberg's Spectralis OCT technology onboard the International Space Station to investigate the effects of microgravity environments on vision. NASA began using the technology in 2013, and in 2019, a second Spectralis device equipped with the OCT2 Module was installed on the space station.

 The collaborative research focuses in part on Space Flight Associated Neuro-Ocular Syndrome (SANS), a condition that which commonly causes unilateral and bilateral optic disc oedema in patients who have spent time in microgravity environments.

“Every day at NASA we learn something new about the impact of space travel on the human body, and ocular health in particular,"  said Hoburg ahead of the meeting. "I am honored to be on this stage with Dr Brunstetter and look forward to sharing our insights, learnings, and experiences with this year’s symposium attendees."

Along with live scientific sessions, attendees will be able to visit the exhibition hall or take a tour of the SkyLabs Tower, Heidelberg Engineering's company headquarters. 

The exhibition hall will feature a showcase of the SeeLuma digital microscope with intraoperative OCT. Following the conclusion of the scientific programme on Friday evening, Heidelberg Engineering will host a boat cruise dinner reception on the river Neckar.

The full scientific programme can be found 

International SPECTRALIS Symposium – AND BEYOND. Press release. Heidelberg Engineering. Published March 7, 2025. Accessed March 7, 2025.

NASA Astronauts Warren Hoburg and Tyson Brunstetter to Headline Heidelberg Engineering’s 2025 International SPECTRALIS Symposium. Press release. Heidelberg Engineering. Published May 22, 2025. Accessed May 22, 2025. 

International SPECTRALIS Symposium and Beyond: Our Best Program. Heidelberg Engineering Academy. Accessed March 7, 2025. 

https://www.academy.heidelbergengineering.com/hedata/e-learning/Totara/Dateien/ScientificProgram_ISS2025_Heidelberg.pdf

In a keynote speech, Warren Hoburg and Tyson J. Brunstetter, OD, PhD, will discuss in-orbit imaging and spaceflight-associated neuro-ocular syndrome

NASA astronaut and clinical lead will deliver keynote at International SPECTRALIS Symposium

Hyperopic treatments have long been a topic of debate, with corneal-based options often pushed aside in favor of intraocular lenses (IOLs). However, recent advancements have reignited interest in corneal laser treatments, particularly with the evolution of LASIK and the introduction of Lenticule Extraction for hyperopia. Officially launched at the ESCRS Barcelona 2024, ZEISS SMILE pro for hyperopia is available as a new application on the ZEISS VISUMAX 800 femtosecond laser platform.

The implementation of SMILE pro for hyperopia on the VISUMAX 800, ZEISS Medical Technology’s most advanced laser system, marks a significant milestone in hyperopia treatment. This breakthrough in hyperopic treatment has shown outcomes comparable to hyperopic LASIK, while offering key benefits of ZEISS SMILE and SMILE pro such as minimized dry eye symptoms and reduced aberration induction.

Step-by-step to success - The journey of Lenticule Extraction for hyperopic patients

While ZEISS SMILE has been successfully used for myopia for years, hyperopic treatments faced initial setbacks, particularly with early prototypes like FLEx (Carl Zeiss Meditec AG), which lacked effective transition zones and used small optical zones. These early designs resulted in poor visual quality and unacceptable levels of regression, causing many to question whether Lenticule Extraction could ever be a viable option for hyperopia.

However, by redesigning the lenticule geometry to include an expanded transition zone and a larger optical zone, ZEISS SMILE pro has become an effective alternative to LASIK for hyperopia. The final lenticule geometry consisted of an optical zone of 6.3 mm with a transition zone of 2 mm, corresponding to a total lenticule diameter of 8.3 mm. A minimum lenticule thickness of 30 μm was used to ensure minimum interface interaction between the lenticule and cap cuts.

Feasibility studies conducted in Nepal using this updated lenticule profile found that the effective zone on topography was equivalent to that achieved by LASIK with a 7 mm optical zone using the ZEISS MEL 90 excimer laser.

 In the same study, it was also found that the centration achieved with hyperopia treatment with Lenticule Extraction (ZEISS SMILE) was no different to hyperopic LASIK, and the visual and refractive results were promising.

Following these studies, a prospective multicenter trial to investigate Lenticule Extraction with ZEISS SMILE for hyperopia was conducted across eight global sites from a diverse range of locations and was published in the Journal of Refractive Surgery in 2022.

 The study included 374 eyes with hyperopia up to +6.00 D and 12-month follow up using an updated nomogram based on the previous results. Overall, it was found that Lenticule Extraction for hyperopia achieved the same level of safety and efficacy as LASIK with the ZEISS MEL 90 excimer laser.

 In this study, the uncorrected distance visual acuity (UDVA) was within one line of their preoperative corrected distance visual acuity (CDVA) in 93% of patients. The refractive stability and visual outcomes were excellent, with no clinically significant loss of contrast sensitivity.

Here we describe the case of a 30-year-old male who presented for refractive surgical correction for hyperopia in both eyes. His refraction was +3.25 -1.75 x 78 (20/20) in the right eye and +3.75 -2.25 x 97 (20/20) in the left eye. He was a contact lens wearer and reported experiencing discomfort for the past eight years, for which he regularly used eye drops. The topography, tomography, and corneal thickness were all normal, and was therefore a suitable candidate for corneal laser refractive surgery. The mean keratometry was 43.89 D in the right eye and 43.91 D in the left eye, so there was ample scope for steepening. In this case, Lenticule Extraction for hyperopia was performed using the ZEISS VISUMAX 800. ZEISS SMILE pro was chosen due to the faster treatment time in addition to its minimally invasive nature and the minimization of dry eye symptoms, a key benefit for this patient.

Back to the cornea – Treating hyperopic patients with Lenticule Extraction

The treatment was planned using the standardized lenticule geometry as described above. Whereas the previous clinical trials had all been performed using the first-generation ZEISS VisuMax, the introduction of the ZEISS VISUMAX 800 includes improvements to the docking procedure including the centration assistant CentraLign

 cyclotorsion adjustment. The iris image is obtained using the ZEISS IOLMaster 700 and digitally imported into the treatment plan. During surgery, the CentraLign algorithm automatically detects the pupil and guides the surgeon to the intended treatment center. After applying suction, the system automatically calculates the cyclotorsion rotation required based on the live image of the iris.

We might expect a benefit in outcomes for cases with high astigmatism such as this patient. The other benefit of the ZEISS VISUMAX 800 is the faster cutting time, which reduces the risk of suction loss, particularly for hyperopic ZEISS SMILE pro where the overall cutting time is longer than for myopic treatments due to the larger lenticule. This aspect not only the potential of minimizing the risk of complications but also contributes to a smoother surgical experience. Due to the large optical zone required for a stable hyperopic correction, the M size contact glass is used with a cap diameter of 8.8 mm. The surgical technique is essentially the same as for myopic ZEISS SMILE or SMILE pro, except that a modified version of the Reinstein SMILE Separator should be used that has a longer 9-mm separating arm (compared to 8 mm for the similar myopic instrument).

This enables the safe separation of the interfaces across the larger cap diameter without the instrument stressing the small incision. Careful separation of the central thinnest region of the lenticule is advised. A course of mild corticosteroids for 1 month was given on completion of the standard first week post-SMILE/SMILE pro medications, in order to prevent interface haze formation.

At the day one appointment, the corneas were clear and the patient was comfortable. UDVA was 20/32 in both eyes with a spherical equivalent refraction of -0.50 D in the right eye and -0.75 D in the left eye. This slight myopic refraction would be expected to shift towards emmetropia with corneal healing and epithelial remodeling over the first 3-6 months, as observed in the previous study and after hyperopic LASIK.

 The topography showed a large and optical zone well centered on the corneal vertex (Figure 1).

The journey of hyperopic corneal treatments from near abandonment to a promising resurgence is a testament to the power of perseverance, research, and innovation in refractive surgery. This has been achieved through our understanding of optical zone and transition zone design to optimize refractive stability, centration relative to the corneal vertex rather than the entrance pupil center and the importance of epithelial mapping for evaluating risks associated with corneal steepening.

Lenticule Extraction for hyperopia with ZEISS SMILE pro presents several advantages over clear lens exchange that make it a compelling option for both surgeons and patients. With its ability to provide outcomes comparable to hyperopic LASIK with less tear film depression, ZEISS SMILE pro for hyperopia using the ZEISS VISUMAX 800 represents a promising advancement in refractive surgery, aligning with the goal of delivering high-quality care and improved patient satisfaction.

 is Medical Director of London Vision Clinic. He is also consultant to and receives travel expenses from Carl Zeiss Meditec AG, and has financial interest in ArcScan Inc.

 Reinstein DZ, Archer TJ, Gobbe M, Bartoli E. Corneal sensitivity after small-incision lenticule extraction and laser in situ keratomileusis. J C ataract Refract Surg. 2015 Aug;41(8):1580-7.

 Reinstein DZ, Pradhan KR, Carp GI, Archer TJ, Gobbe M, Sekundo W, Khan R, Citron K, Dhungana P. Small Incision Lenticule Extraction (SMILE) for Hyperopia: Optical Zone Centration. J Refract Surg. 2017 Mar 1;33(3):150-156

 Pradhan KR, Reinstein DZ, Carp GI, Archer TJ, Dhungana P. Small Incision Lenticule Extraction (SMILE) for Hyperopia: 12-Month Refractive and Visual Outcomes. J Refract Surg. 2019 Jul 1;35(7):442-450. doi: 10.3928/1081597X-20190529-01. PMID: 31298724.

 Reinstein DZ, Sekundo W, Archer TJ, Stodulka P, Ganesh S, Cochener B, Blum M, Wang Y, Zhou X. SMILE for Hyperopia With and Without Astigmatism: Results of a Prospective Multicenter 12-Month Study. J Refract Surg. 2022 Dec;38(12):760-769.

 Reinstein DZ, Carp GI, Archer TJ, Day AC, Vida RS. Outcomes for Hyperopic LASIK With the MEL 90® Excimer Laser. J Refract Surg. 2018 Dec 1;34(12):799-808.

 Reinstein DZ, Gobbe M, Archer TJ. Coaxially sighted corneal light reflex versus entrance pupil center centration of moderate to high hyperopic corneal ablations in eyes with small and large angle kappa. J Refract Surg. 2013 Aug;29(8):518-25.

 Reinstein DZ, Carp GI, Archer TJ, Buick T, Gobbe M, Rowe EL, Jukic M, Brandon E, Moore J, Moore T. LASIK for the Correction of High Hyperopic Astigmatism With Epithelial Thickness Monitoring. J Refract Surg. 2017 May 1;33(5):314-321.

Lenticule Extraction for treating patients with hyperopia is now available with SMILE® pro, performed on the VISUMAX® 800 from ZEISS. This additional option provides a valuable corneal-based alternative for younger patients without cataract. In this Case of the Month, you will discover the advantages of this procedure and review the outcomes of a 30-year-old patient who chose to undergo Lenticule Extraction with ZEISS SMILE pro after experiencing discomfort with contact lenses for many years.

Chirag Jhaveri, MD

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