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Previous episodes
John Kitchens, MD, recaps the inaugural Kiawah Eye Retina meeting, then he and Scott Krzywonos break down Outlook Therapeutics' FDA appeal win for ONS-5010 and what an approved ophthalmic bevacizumab could mean for practices and patients. John B. Miller, MD, previews the Mass Eye and Ear Vitrectomy Course, and the Vitreoretinal View dives into Encelto for MacTel2 — including how AI may help catch it earlier.
Here are the restructured show notes:
RetinUp – Episode: Globe Project & FDA Uncertainty | Plus Arshad Khanani, MD, on Clinical Trials at the Summit | Plus MacTel Image of the Month
Guests: Arshad M. Khanani, MD, MA – Managing Partner, Director of Clinical Research & Director of Fellowship, Sierra Eye Associates; Clinical Professor, University of Nevada, Reno School of Medicine; Founder & Co-Chair, Clinical Trials at the Summit
Roger A. Goldberg, MD, MBA – Bay Area Retina Associates
Show Summary
John Kitchens, MD, joins from Kiawah Island for the inaugural Kiawah Eye Retina meeting as he and Scott Krzywonos break down two pressing policy stories: what the GLOBE Project actually means for retina practices, and what the FDA's ongoing leadership vacuum could mean for drug approvals and smaller companies with limited runway.
Arshad M. Khanani, MD, MA, then previews Clinical Trials at the Summit (CTS), the invite-only meeting he founded to bring physicians, industry, and sponsors into open conversation.
The episode closes with Image of the Month: Roger A. Goldberg, MD, MBA, walks through a MacTel Type 2 case using Optos Silverstone RGB ultra-widefield imaging, autofluorescence, and fluorescein angiography — including a post-operative image of an Encelto implant in situ.
Hosts: John Kitchens, MD, Scott Krzywonos
Topics Covered
The GLOBE Project
CMS Medicare drug pricing demonstration affecting ~25% of practices, selected geographically at random; launching September or October 2026.
Mechanism: pharma companies owe a rebate to the government based on lowest prices paid in comparable countries — but after ASP is established; practice-level reimbursement is not expected to change.
All details subject to change under the current policy environment.
FDA Leadership Void
Commissioner Marty Makary departed May 12, 2026; Kyle Diamantis appointed acting leader; all three top FDA positions now filled by acting officials (210-day limit under federal law).
Broader HHS gaps: no Senate-confirmed surgeon general, NIH head doubling as acting CDC director.
Phase 3 programs already underway are relatively insulated; early-stage companies face the greatest risk from delays and unpredictability.
Replimune precedent: FDA approved a trial design, then denied approval after positive data — a cautionary example for industry.
Hosts forecast 2027 as a difficult year for FDA approvals.
Clinical Trials at the Summit (Arshad M. Khanani, MD, MA)
Founded 2021; first live meeting 2022; now in its sixth year; held June 13, 2026, in Las Vegas.
Bridges sponsors, sites, CROs, and physicians in a format where industry and academic physicians can speak openly — unlike traditional CME meetings.
Small and invite-only by design; global faculty across career stages; practicing physicians involved in trials may request an invitation at ctsretina.org.
2026 highlights: fireside chats with Wiley Chambers (former FDA ophthalmology head) and Pravin Dugel, MD; first-time Phase 3 late-breaking data; Wall Street and CEO panels; video competition.
Image of the Month: MacTel Type 2 & Encelto (Roger A. Goldberg, MD, MBA)
Multimodal imaging case using Optos Silverstone RGB: ultra-widefield color, autofluorescence, and fluorescein angiography demonstrate classic MacTel findings — luteal pigment disruption, right-angle vessel branching, and parafoveal temporal leakage.
SLO technology enables quality imaging through media opacities and small pupils.
Second case: post-op ultra-widefield image of Encelto (revakinagene taroretcel-lwey, Neurotech Pharmaceuticals) CNTF implant positioned inferotemporally; SLO extended depth of field keeps both implant and posterior pole in focus.
Clinical pearl: ultra-widefield imaging contextualizes disease extent for patients — only 2% of the retina affected, but in the wrong location.
Key Takeaways
The GLOBE Project is not expected to affect practice-level reimbursement; the financial adjustment falls on manufacturers.
FDA instability poses the greatest risk to early-stage companies; 2027 may be a difficult year for the retina pipeline.
CTS is a must-attend for anyone involved in clinical trials — intimate format, global faculty, and first-time data every year.
Encelto is the first approved therapy to slow MacTel progression; ultra-widefield imaging is a key tool for diagnosis, monitoring, and patient education.
Sponsors
RetinUp is an editorially independent podcast supported with advertising.
This episode is sponsored by Astellas. Learn more at Astellas.com.
This episode is sponsored by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.
The images in this episode were captured using the Optos Silverstone RGB. Learn more at Optos.com/products/silverstone.
Credits
Production & Marketing: Laura Brown | Business Operations: Liz Hogan
🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
John Kitchens, MD, and Scott Krzywonos break down the GLOBE Project and the FDA's leadership vacuum. Arshad M. Khanani, MD, MA, previews Clinical Trials at the Summit, and Roger A. Goldberg, MD, MBA, presents a MacTel Type 2 Image of the Month using Optos Silverstone RGB imaging — including a post-op view of an Encelto implant.
Show Summary
John Kitchens, MD, joins from Kiawah Island for the inaugural Kiawah Eye Retina meeting as he and Scott Krzywonos break down two pressing policy stories: what the GLOBE Project actually means for retina practices, and what the FDA's ongoing leadership vacuum could mean for drug approvals and smaller companies with limited runway.
Arshad M. Khanani, MD, MA, then previews Clinical Trials at the Summit (CTS), the invite-only meeting he founded to bring physicians, industry, and sponsors into open conversation.
The episode closes with Image of the Month: Roger A. Goldberg, MD, MBA, walks through a MacTel Type 2 case using Optos Silverstone RGB ultra-widefield imaging, autofluorescence, and fluorescein angiography — including a post-operative image of an Encelto implant in situ.
Hosts: John Kitchens, MD, Scott Krzywonos
Guests: Arshad M. Khanani, MD, MA – Managing Partner, Director of Clinical Research & Director of Fellowship, Sierra Eye Associates; Clinical Professor, University of Nevada, Reno School of Medicine; Founder & Co-Chair, Clinical Trials at the Summit
Roger A. Goldberg, MD, MBA – Bay Area Retina Associates
Topics Covered
The GLOBE Project
CMS Medicare drug pricing demonstration affecting ~25% of practices, selected geographically at random; launching September or October 2026.
Mechanism: pharma companies owe a rebate to the government based on lowest prices paid in comparable countries — but after ASP is established; practice-level reimbursement is not expected to change.
All details subject to change under the current policy environment.
FDA Leadership Void
Commissioner Marty Makary departed May 12, 2026; Kyle Diamantis appointed acting leader; all three top FDA positions now filled by acting officials (210-day limit under federal law).
Broader HHS gaps: no Senate-confirmed surgeon general, NIH head doubling as acting CDC director.
Phase 3 programs already underway are relatively insulated; early-stage companies face the greatest risk from delays and unpredictability.
Replimune precedent: FDA approved a trial design, then denied approval after positive data — a cautionary example for industry.
Hosts forecast 2027 as a difficult year for FDA approvals.
Clinical Trials at the Summit (Arshad M. Khanani, MD, MA)
Founded 2021; first live meeting 2022; now in its sixth year; held June 13, 2026, in Las Vegas.
Bridges sponsors, sites, CROs, and physicians in a format where industry and academic physicians can speak openly — unlike traditional CME meetings.
Small and invite-only by design; global faculty across career stages; practicing physicians involved in trials may request an invitation at ctsretina.org.
2026 highlights: fireside chats with Wiley Chambers (former FDA ophthalmology head) and Pravin Dugel, MD; first-time Phase 3 late-breaking data; Wall Street and CEO panels; video competition.
Image of the Month: MacTel Type 2 & Encelto (Roger A. Goldberg, MD, MBA)
Multimodal imaging case using Optos Silverstone RGB: ultra-widefield color, autofluorescence, and fluorescein angiography demonstrate classic MacTel findings — luteal pigment disruption, right-angle vessel branching, and parafoveal temporal leakage.
SLO technology enables quality imaging through media opacities and small pupils.
Second case: post-op ultra-widefield image of Encelto (revakinagene taroretcel-lwey, Neurotech Pharmaceuticals) CNTF implant positioned inferotemporally; SLO extended depth of field keeps both implant and posterior pole in focus.
Clinical pearl: ultra-widefield imaging contextualizes disease extent for patients — only 2% of the retina affected, but in the wrong location.
Key Takeaways
The GLOBE Project is not expected to affect practice-level reimbursement; the financial adjustment falls on manufacturers.
FDA instability poses the greatest risk to early-stage companies; 2027 may be a difficult year for the retina pipeline.
CTS is a must-attend for anyone involved in clinical trials — intimate format, global faculty, and first-time data every year.
Encelto is the first approved therapy to slow MacTel progression; ultra-widefield imaging is a key tool for diagnosis, monitoring, and patient education.
Sponsors
RetinUp is an editorially independent podcast supported with advertising.
This episode is sponsored by Astellas. Learn more at Astellas.com.
This episode is sponsored by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.
The images in this episode were captured using the Optos Silverstone RGB. Learn more at Optos.com/products/silverstone.
Credits
Production & Marketing: Laura Brown | Business Operations: Liz Hogan
🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
Hunter Cherwek, MD, pulls back the curtain on Orbis International — from the Flying Eye Hospital to AI-powered DR screening and trachoma eradication. Then Frank Brodie, MD, MBA, explains LensOne™, a prosthetic capsular bag designed to solve secondary IOL fixation, and previews the GOLDEN GATE pivotal trial launching this fall.
Show Summary
Hunter Cherwek, MD, Vice President of Clinical Services & Technologies at Orbis International, joins John and Scott to discuss how Orbis has evolved from a single Flying Eye Hospital into a global force spanning AI-powered diagnostics, distance learning, drug distribution, and children's eye care.
Frank Brodie, MD, MBA, co-inventor of LensOne™, then joins to explain what the prosthetic capsular bag solves, how it works, and where it's headed — including the upcoming GOLDEN GATE pivotal trial launching this fall.
Hosts: John Kitchens, MD, Scott Krzywonos
Topics Covered
Hunter Cherwek, MD, on Orbis International
Orbis founded 1982; the Flying Eye Hospital — a US-accredited hospital aboard an MD-10 aircraft — now represents ~15% of Orbis activity.
CyberSight: the world's largest freely available ophthalmic distance learning platform; recently hosted a live lecture watched by 127 countries simultaneously; originated as a pediatric mentorship program by Eugene Helveston, MD.
Trachoma eradication: Orbis distributes 200–250 million doses of azithromycin annually in Ethiopia; Hunter projects eradication within 10 years.
AI and diabetic retinopathy: RAIDERS trial in Rwanda (conducted entirely during COVID, fully remote) showed a 40% improvement in referral rates to medical retina; B-PRODUCTIVE study in Bangladesh improved retina clinic procedural volume by 248%.
Oculomics: Orbis is now using retinal AI biomarkers to detect systemic disease, positioning the eye as a window into neurovascular health.
450+ volunteers from 40+ countries; the associate program allows residents to observe (not operate) and build global health foundations early in training.
How to get involved: orbis.org — volunteer tab at the top of the site; particular need for ROP, inherited retinal disease, and pediatric retina specialists.
Frank Brodie, MD, MBA, on LensOne™
The problem: secondary IOL fixation (Yamane, four-point fixation, glued IOL) has a 14% re-operation rate per a large IRIS Registry study; no FDA-approved solution currently exists beyond ACIOL, which fewer than 10% of surgeons use.
LensOne™: a three-point fixated prosthetic capsular bag made by Long Bridge Medical; accommodates virtually any IOL type including toric and multifocal; injected through standard cannula incisions in roughly three minutes.
First-in-human trial: 15 patients in Sydney, Australia; 100% successful implantation; no conjunctival erosion or IOL dislocation; published in Ophthalmology (AAO journal) with surgical videos available online.
GOLDEN GATE trial: US pivotal study; ~12 sites; 110–130 patients; launching fall 2026; market entry targeted for late 2028–early 2029.
Training: bench-top only (model eyes and ex vivo porcine); no live animal training required; most steps are intuitive for retina surgeons already familiar with pars plana approaches.
More information and surgical animations: longbridgemedical.com.
Key Takeaways
Orbis has evolved far beyond the Flying Eye Hospital — it is now a global AI, telemedicine, and drug distribution organization reaching the world's most underserved patients, and retina specialists can plug in at any career stage.
LensOne™ addresses a real and underappreciated problem: secondary IOL surgery is technically demanding, legally risky, financially penalized, and currently without an FDA-approved solution beyond ACIOL.
The GOLDEN GATE trial launches this fall; surgeons interested in participating should visit longbridgemedical.com.
Sponsors
RetinUp is an editorially independent podcast supported with advertising.
Watch the Purple Chair series at Vabysmo-HCP.com.
Learn more about Unity VCS at UnityVCS.com.
Credits
Production & Marketing: Laura Brown | Head of Production: Liz Hogan
🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube