Innovation in ophthalmology

Won FDA Premarket Approval for STAAR Surgical’s EVO Visian Implantable Collamer Lens (ICL) in March 2022 by persuading FDA to shorten duration of the required clinical trial endpoints from 3 years to 6 months.  Beginning in 2015, worked closely with team to remediate prior deficiencies cited by FDA, allowing approval of STAAR’s Toric ICL in 2018 and EVO ICL Investigational Device Exemption in 2019.  As Medical Monitor, worked closely with VP of Clinical Affairs, Global Head of Regulatory Affairs and Global Head of Clinical Operations to design and implement clinical trial, train investigators, resolve FDA deficiencies, respond to FDA interactive reviews, ensure safety of study subjects, write clinical study report, summary of safety and effectiveness, directions for use and patient information brochure.  Published three landmark papers establishing ICL clinical pedigree and reporting results from the FDA clinical trial: “Meta-Analysis and Review:  Effectiveness, Safety and Central Port Design of the Intraocular Collamer Lens (ICL),” “The Implantable Collamer Lens with a central port: review of the literature” and “Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six Month Results from the United States Food and Drug Administration Clinical Trial,” all in Clinical Ophthalmology.  

Championed the Bausch & Lomb Trulign Toric Intraocular Lens at the Ophthalmic Devices Panel of the FDA Medical Devices Advisory Committee Meeting on April 8, 2013, overcoming FDA’s position that a lack of evidence of accommodation implied a failure of effectiveness. Persuaded the panel that the clinical trial design, which had been approved by FDA, was never intended to demonstrate accommodation, but only to show correction of astigmatism: “Well, let me say if the elephant in the room is accommodation, I share your frustration because this study was never designed to prove accommodation. This study was designed to prove the correction of astigmatism by a toric optic that was added to an accommodative intraocular lens parent platform. And I would just like to remind you all as scientists that absence of evidence is not evidence of absence.” The panel voted 10 yes, 0 noes, 2 abstains for safety, 10 yes, 1 abstain, 1 no for effectiveness, and 10 yes, 1 no and 1 abstain that the benefits outweigh the risks.  FDA approved the Trulign Toric IOL on May 20, 2013. 

Introduced aspheric intraocular lens design to the global cataract market as Principal Investigator, Clinical Consultant, Medical Monitor and Key Opinion Leader for Tecnis Intraocular Lenses (Advanced Medical Optics, now JNJ Vision) from 2001 through 2013.  Published “Aspheric Intraocular Lens Selection Based on Corneal Wavefront” in the Journal of Refractive Surgery and “Evaluation of the Aspheric Tecnis Multifocal Intraocular Lens” in the American Journal of Ophthalmology.

Spearheaded clinical investigation of intraoperative aberrometry to improve refractive outcomes of cataract surgery as Principal Investigator and Clinical Consultant to WaveTec Vision from 2007 through 2014.  Published first peer-reviewed report of astigmatism correction based on intraoperative wavefront measurements, “Effect of intraoperative aberrometry on the rate of postoperative enhancement” in the Journal of Cataract and Refractive Surgery.  Alcon acquired WaveTec in 2014 and integrated intraoperative aberrometry in their surgical suite as the Optiwave Refractive Analysis (ORA) System.

Served as Managing Partner of Drs. Fine, Hoffman & Packer in Eugene, Oregon, from 2002 through 2012, a high-profile ophthalmic practice dedicated to international teaching, publishing, and speaking on the investigation, adoption, and integration of new technology for cataract and refractive surgery.  Built successful clinical research department, recruited director, trained clinical research coordinators, attracted industry sponsorships, negotiated clinical trial agreements, optimized workflow for clinical studies and interfaced with IRBs and FDA. 

Established reputation for insight, innovation and leadership as advisor to ophthalmic device and pharmaceutical companies, including Abbott Medical Optics, Advanced Medical Optics, Advanced Vision Science, Aerie Pharmaceuticals, Alcon, Allergan, Amaros, Aquea Health, Bausch & Lomb, Beaver Visitec International, Bruno Vision Care, Carl Zeiss Meditec, Cassini Technologies, Celgene, Endo Optiks, General Electric Health Care, GenSight, Iantech, International Biomedical Devices, Johnson & Johnson, Keranova, LENSAR, LensGen, MedTrials, Medtronic, Oculeve, Olympic Ophthalmics, OnPoint Vision, Pharmacia, PhysIOL, Precision for Medicine, Presbia, Promedica International, Precision for Medicine, PTC Therapeutics, Rayner, Refocus Group, Santen, SOLX, STAAR Surgical, Stepwise Medical, Tarsus Pharmaceuticals, Transcend Medical, Trefoil Therapeutics, True Vision Systems, Visant Medical, VisionCare Ophthalmic Technologies and WaveTec Vision Systems.