ALLOFLO™ UVEO Clinical Evidence

BIO-REINFORCED CYCLODIALYSIS

From the CREST Study, multiple peer-reviewed papers have been published evaluating safety and efficacy of bio-reinforced cyclodialysis in a diverse population with glaucoma severity ranging from mild to severe.

Efficacy

32-40%

MEAN POST-OPERATIVE IOP REDUCTION ^2-5

12-24 month

32-40% Mean IOP Reduction, 12-24 months

40-64%

MEAN POST-OPERATIVE REDUCTION OF OHT MEDICATIONS^2-5

12-24 month

40-64% Mean Medication Reduction, 12-24 months

2. Ianchulev T., et al.3. Chaya CJ., et al.4. Calvo E., et al.5. Barber K., et al.

Safety

< 0.5%

CLINICAL HYPOTONY³

≥ 30 days post-op

32-40% Mean IOP Reduction, 12-24 months

< 5%

ELEVATED IOP^*3

at/after 1 month post-op

32-40% Mean IOP Reduction, 12-24 months

< 10%

ENDOTHELIAL CELL LOSS**⁴

24 months post-op

32-40% Mean IOP Reduction, 12-24 months

* Procedure related, >30 mmHg or +10 mmHg from baseline

** Consistent with expected loss seen after cataract surgery procedures. No eyes had significant (>30%) endothelial cell loss.⁶

6. Perone J-M, Luc M-S, Zevering Y, Vermion J-C, Gan G, Goetz C. Narrative review after post-hoc trial analysis of factors that predict corneal endothelial cell loss after phacoemulsification: Tips for improving cataract surgery research. PLoS One. 2024;19(3):e0298795. doi:10.1371/journal.pone.0298795

3. Chaya CJ., et al.4. Calvo E., et al.

AlloFlo^TM Uveo Indications for Use: AlloFlo^TM Uveo is scleral allograft tissue intended for use to scaffold, bracket, stent, bridge, or provide scleral reinforcement and other structural support (e.g. endoscleral, episcleral, trans-scleral, supraciliary/suprachoroidal) in ocular surgery.

AlloSert^TM Uveo Indications for Use: AlloSert^TM Uveo is a manual surgical instrument used for the ab-interno construction or modificationof a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials toreinforce and maintain the cyclodialysis cleft.

PN: 900214 Rev A

The Crest Study

One of the largest study cohorts in interventional glaucoma. Subjects prospectively followed through 2 years post-surgery.

500+

eyes enrolled

locations

years post-op follow-up

peer-reviewed publications

2. Ianchulev T., et al.4. Calvo E., et al.

AlloFlo^TM Uveo Indications for Use: AlloFlo^TM Uveo is scleral allograft tissue intended for use to scaffold, bracket, stent, bridge, or provide scleral reinforcement and other structural support (e.g. endoscleral, episcleral, trans-scleral, supraciliary/suprachoroidal) in ocular surgery.

AlloSert^TM Uveo Indications for Use: AlloSert^TM Uveo is a manual surgical instrument used for the ab-interno construction or modificationof a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials toreinforce and maintain the cyclodialysis cleft.

PN: 900214 Rev A

Contributors

THE CREST STUDY

Lautaro Vera, MD

Toby Tyson, MD

James Lewis, MD

Won Kim, MD

Stephen Smith, MD

Reena Garg, MD

Gabriel Ferreira, MD

Eva Liang, MD

Ehsan Sadri, MD

Rajen Desai, MD

Deepan Selvadurai, MD

Craig Chaya, MD

Brian Flowers, MD

Arian Moses, MD

Peer-reviewed Publications

Ianchulev T, Weinreb RN, Calvo EA, et al. Bio-interventional cyclodialysis and allograft scleral reinforcement for uveoscleral outflow enhancement in open-angle glaucoma patients: One-year clinical outcomes. Clin Ophthalmol. 2024 Dec 6;18:3605-3614. doi:10.2147/OPTH.S496631

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Chaya CJ, Herndon LW, Lince J, Radcliffe N, Sadri E, Yadgarov A, Ianchulev T. Surgical outcomes, ocular safety and tolerability of bio-interventional cyclodialysis with allograft scleral reinforcement: Clinical experience of more than 240 cases. J Clin Med. 2024 Aug 6;13(16):4593. doi:10.3390/jcm13164593

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Calvo E, De Francesco T, Vera L, Tyson F, Weinreb RN. Bio-interventional uveoscleral outflow enhancement surgery for primary open-angle glaucoma: 2-year results of cyclodialysis with scleral allograft reinforcement. Ophthalmol Sci. 2025;5(4):100727. doi:10.1016/j.xops.2025.100727

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Stamper R, Huang A, Toris C, Qiu M, Gray G, Garg R, Ianchulev T. Cyclodialysis Surgery for Glaucoma Management: A Systematic Review and Meta-Analysis of 100 Years of Clinical Evidence. Clin Ophthalmol. 2025 Aug 21;19:2859-2870. doi: 10.2147/OPTH.S538438. PMID: 40861323; PMCID: PMC12377377.

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De Francesco T, Ianchulev T, Rhee DJ, Gentile RC, Pasquale LR, Ahmed IIK. The Evolving Surgical Paradigm of Scleral Allograft Bio-Tissue Use in Ophthalmic Surgery: Techniques and Clinical Indications for Ab-Externo and Ab-Interno Scleral Reinforcement. Clin Ophthalmol. 2024 Jun 21;18:1789-1795. doi: 10.2147/OPTH.S462719. PMID: 38919403; PMCID: PMC11198013.

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Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi:10.1177/25158414251362010

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Ianchulev T, Weinreb RN, Kamthan G, Calvo E, Pamnani R, Ahmed IK. Biotissue stent for supraciliary outflow in open-angle glaucoma patients: surgical procedure and first clinical results of an aqueous drainage biostent. Br J Ophthalmol. 2024 Jan 29;108(2):217-222. doi: 10.1136/bjo-2022-322536. PMID: 36593090; PMCID: PMC10850681.

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Presentations

The Uveoscleral Path Awaits. ASCRS 2025 - Presenters, A Sheybani, MD; N Radcliffe, MD; L Provencher, MD.

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Back to the future: Next Generation Suprachoroidal Stenting. Glaucoma 360 - Presenter, R Weinreb, MD.

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Circumferential Goniotomy with Superelastic Microfilament As Adjunct to Bio-Interventional Uveoscleral Surgery for Dual-Outflow Enhancement. Presenter, A Yadgarov, MD.

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Back to the future Next Generation Suprachoroidal Stenting. Presenter, R Weinreb, MD.

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Bio-interventional Cyclodialysis in Patients Undergoing Cataract Surgery and Failing IOP Control with Topical Medication Therapy. 2025 - Presenter, R Weinreb, MD.

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Next Generation Glaucoma μ- Interventions. AECOS 2022 - Presenter, T Tyson, MD

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Endothelial Health After BiointerventionalScleral Allograft Reinforcement and Ab Interno Cyclodialysis in Eyes Undergoing Cataract Surgery: 24-Month Results. AAO 2025 - Presenter, A Sheybani, MD.

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Bio-interventional Uveoscleral Outflow Enhancement Cyclodialysis And Allograft Bio-Reinforcement. Presenter, A Sheybani, MD.

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Bio-reinforced cyclodialysis for uveoscleral outflow enhancement in pseudophakic eyes: one-year outcomes. AAO 2025 - Presenter, S Sarkisian, MD.

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Bio-Interventional Uveoscleral Outflow Enhancement with Allograft-Reinforced Cyclodialysis: 12-Month Results. ASCRS 2025 - Presenter, J Lewis, MD.

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Two-year Outcomes of Bio-interventional Cyclodialysis Surgery Enhanced by Scleral Allograft Reinforcement. AGS - Presenter, L Herndon, MD.

Read

Continuous Circumferential Trabeculorrhexis (CCT) Using Super-Elastic Memory-Shaped Nitinol. Presenter, G Kamthan, MD.

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Two-Year Outcomes of Bio-Interventional Cyclodialysis Surgery Enhanced By Scleral Allograft Reinforcement. ASCRS 2025 - Presenter, L Herndon, MD.

Read

Bio-interventional Uveoscleral Outflow Enhancement through Allograft-reinforced Cyclodialysis: 12-month Outcome. AGS - Presenter, T De Francesco, MD.

Read

Outflow Facility of Single vs Dual Wall Canalotomy. University of Nebraska - Presenter, S Fan, MD.

Read

Dual Allogeneic Bioscaffold Reinforcement Following Ab Interno Cyclodialysis in Combination With Cataract Surgery: One-Year Results. AAO 2025 - Presenter, J Bacharach, MD.

Read

AlloFlo^TM Uveo Indications for Use: AlloFlo^TM Uveo is scleral allograft tissue intended for use to scaffold, bracket, stent, bridge, or provide scleral reinforcement and other structural support (e.g. endoscleral, episcleral, trans-scleral, supraciliary/suprachoroidal) in ocular surgery.

AlloSert^TM Uveo Indications for Use: AlloSert^TM Uveo is a manual surgical instrument used for the ab-interno construction or modificationof a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials toreinforce and maintain the cyclodialysis cleft.

Contributors

PEER-REVIEWED PUBLICATIONS

Lautaro Vera, MD

Michael Patterson, DO

Arkadiy Yadgarov, MD

Robert Weinreb, MD

Ticiana De Francesco, MD

Arsham Sheybani, MD

Nate Radcliffe, MD

Leon Herndon, MD

Kevin Barber, MD

Gautam Kamthan, MD

Jorge Lince, MD

Douglas Rhee, MD

Ernesto Calvo, MD

Ehsan Sadri, MD

Craig Chaya, MD

Brian Flowers, MD

Presentation Request

To request presentation slides of our clinical data, please submit your information here. We'll get back to you within 1-2 business days.

Thank you! Your submission has been received!

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The Crest Study

One of the largest prospective cohorts in interventional glaucoma.

>450

eyes enrolled

locations

years

4 PEER-REVIEWED PUBLICATIONS

117 eyes at 12 months ²

SAFETY &
EFFICACY

31 eyes at 24 months ⁴

SAFETY &
EFFICACY

243 eyes at 24 months ⁴

POST-OP SAFETY ANALYSIS

51 medically uncontrolled eyes at 12 months ²

SAFETY &
EFFICACY

2. Ianchulev T., et al.4. Calvo E., et al.

Traditional
CycloDIALYSIS

The ability for cyclodialysis to significantly reduce IOP has beenunderstood for over 100 years.

Meta-analysis of 40 evidence-based studies: ¹

More than 4,000 eyes

Data collected over a 100-year period

Up to 10 years of follow-up

Demonstrated average success rate comparable to MIGS

*Across all studies, the average qualified success rate was 72.3% (range: 33-97%) over follow-up periods of 6 to 132 months.

1. Stamper, R., et al.

EFFICACY OF BIO-REINFORCED CYCLODIALYSIS

Multiple published studies evaluated safety and efficacy with statistically significant outcomes.
Studies included a diverse population, ranging in disease severity from mild to severe.

≤ 15.2 mmHg

MEAN POST-OPERATIVE IOP ^2-5

12-24 month

≤ 0.8

MEAN POST-OPERATIVE NUMBER OF OHT MEDICATIONS^2-5

12-24 month

*Across all studies, the average qualified success rate was 72.3% (range: 33-97%) over follow-up periods of 6 to 132 months.

2. Ianchulev T., et al.3. Chaya CJ., et al.4. Calvo E., et al.5. Barber K., et al.

SAFETY PROFILE OF BIO-REINFORCED CYCLODIALYSIS

243 eyes

Timeframe

Percent of eyes

Clinical Hypotony³

≥ 30 days

< 0.5%

Elevated IOP^**3

At/after 1 month post-op

< 5%

** Procedure related, >30 mmHg or +10 mmHg from baseline

31 eyes

Timeframe

Mean ECL

Endothelial Cell Loss⁴

24 months

< 10%†

† Consistent with expected loss seen after cataract surgery procedures. No eyes had significant (>30%) endothelial cell loss.

243 eyes

Timeframe

Percent of eyes

Clinical Hypotony³

≥ 30 days

< 0.5%

Elavated IOP^**3

At/after 1 month post-op

< 0.5%

31 eyes

Timeframe

Main ECL

Endothelial Cell Loss⁴

24 months

< 10%†

3. Chaya CJ., et al.4. Calvo E., et al.

Real-world Application

Bio-intervention with AlloFlo^TM Uveo

3,000+

CASES ⁶

100+

U.S. SURGEONS ⁶

Contributors

PEER-REVIEWED PUBLICATIONS

Lautaro Vera, MD

Robert Weinreb, MD

Ticiana De Francesco, MD

Arsham Sheybani, MD

Nate Radcliffe, MD

Michael Patterson, DO

Leon Herndon, MD

Kevin Barber, MD

Gautam Kamthan, MD

Jorge Lince, MD

Douglas Rhee, MD

Ernesto Calvo, MD

Arkadiy Yadgarov, MD

Ehsan Sadri, MD

Craig Chaya, MD

Brian Flowers, MD

THE CREST STUDY

Lautaro Vera, MD

Won Kim, MD

Toby Tyson, MD

Stephen Smith, MD

Reena Garg, MD

James Lewis, MD

Gabriel Ferreira, MD

Eva Liang, MD

Ehsan Sadri, MD

Rajen Desai, MD

Deepan Selvadurai, MD

Craig Chaya, MD

Brian Flowers, MD

Arian Moses, MD

Surgical Videos

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Presentation Request

To request presentation slides of our clinical data, please submit your information here. We'll get back to you within 1-2 business days.

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ALLOFLO™ UVEO Clinical Evidence

BIO-REINFORCED CYCLODIALYSIS

From the CREST Study, multiple peer-reviewed papers have been published evaluating safety and efficacy of bio-reinforced cyclodialysis in a diverse population with glaucoma severity ranging from mild to severe.

Efficacy

Safety

The Crest Study

Presentation Request

The Crest Study

Traditional
CycloDIALYSIS

Real-world Application

Surgical Videos

Presentation Request

Bio-Interventional Technologies

Micro-Interventional Technologies

ALLOFLO™ UVEO Clinical Evidence

BIO-REINFORCED CYCLODIALYSIS

From the CREST Study, multiple peer-reviewed papers have been published evaluating safety and efficacy of bio-reinforced cyclodialysis in a diverse population with glaucoma severity ranging from mild to severe.

Efficacy

Safety

The Crest Study

Presentation Request

The Crest Study

TraditionalCycloDIALYSIS

Real-world Application

Surgical Videos

Presentation Request

Traditional
CycloDIALYSIS