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PN eumatic T rabeculoplasty (PNT)

PN eumatic T rabeculoplasty (PNT). An Alternative Approach for the Long Term Management of POAG and OH Patients. John W. Sharkey, Ph.D. President – Ophthalmic International. Management Team.

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PN eumatic T rabeculoplasty (PNT)

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  1. PNeumatic Trabeculoplasty(PNT) An Alternative Approach for the Long Term Management of POAG and OH Patients John W. Sharkey, Ph.D. President – Ophthalmic International

  2. Management Team • G. Richard Smith – CEO Over 25 years in development and manufacturing of ophthalmic devices and co-inventor of PNT • John W. Sharkey, Ph.D. – President. 20 years experience in global health care industry • Francesco Aspes, M.D. – Head of Europe. 25 yeas experience in global health care industry

  3. Glaucoma • World Health Organization found glaucoma to be second leading cause of blindness worldwide, second only to cataracts • Glaucoma is leading cause of visual field loss in people over age 55, followed by stroke • Approximately 62% of patients discontinue and 18% change their initial glaucoma medication within 18 months of diagnosis • Surgical intervention does not eliminate need for pharmaceutical treatments • Glaucoma is a progressive disease and patients progress to multiple medications and surgery over time

  4. What is Glaucoma? • Glaucoma is a group of neurodegenerative eye diseases • The Optic Nerve is damaged • Several forms of glaucoma have associated with them Elevated Intraocular Pressure (IOP) • It is an asymptomatic disease that is significantly under diagnosed • The disease is typically associated with aging and there is no cure

  5. Glaucoma Market • Treatments for glaucoma account for almost half of the present market for ophthalmic pharmaceuticals • Global ophthalmic marketplace is approximately USD $ 4 billion and is expected to grow to USD$ 7 billion by 2009 • In excess of 1% of the U.S. population is estimated to have glaucoma • It is estimated that only 50% of U.S. glaucoma patients are diagnosed and therefore eligible for treatment

  6. Market Drivers • Aging population – Incidence of glaucoma increases with age • More aggressive diagnosis – with growing recognition of the long term consequences of untreated glaucoma, several initiatives underway world-wide to improve diagnosis and initiate treatment • Improved Compliance – recognition that poor patient compliance is a major component of poor medical outcomes

  7. What is Ocular Hypertension? • Ocular Hypertension(OH) • Intraocular Pressure (IOP) is elevated but • Optic Nerve is normal therefore no visual deterioration • 4-10% of the U.S. population over 40 years of age have elevated IOP. • The Ocular Hypertension Treatment Study (OHTS) estimated patients risk at 10% to develop glaucoma within a 5 year period. • Risk can be reduced to 5% with active IOP control

  8. Why OH Is Not Aggressively Treated • Many physicians hesitate medically treating OH since • Most OH patients will not develop glaucoma • Side effect profile for ocular anti-glaucoma medications are not benign and treatment is life-long • Therefore a large number of physicians will monitor and if glaucoma develops will then try to manage The OH market represents an equally large market for a safe, effective treatment with minimal side effects

  9. Origins of PNT • Relationship between corneal thickness and measured IOP has been known for over 50 years • Several studies have shown that following PRK and LASIK procedures there is a drop on measured IOP which correlates to the amount of material removed Goldmann H, Schmidt T. Über Applanationstonometrie. Ophthalmologica 1957;134:221–42. Emara B, Probst LE, Tingey DP, et al. Correlation of intraocular pressure and central corneal thickness in normal myopic eyes and after laser in situ keratomileusis. J Cataract Refract Surg 1998;24:1320–5.

  10. Relationship Between Pachymetry and IOP • A significant number of patients exhibit a reduction of the IOP after refractive surgery • The explanation most frequently used was that the reduction was a secondary artifact to the change of rigidity of the cornea due to interrupting Bowman membrane • A number of studies proposed that that the reduction of the IOP post-LASIK was a real event and not fully attributable to changes in the thickness of the cornea

  11. What happens to corneal thickness following Lasik and PRK • The study was designed to determine changes in the corneal thickness and IOP following LASIK (25 patients) or PRK (20 patients) • Near-sighted patients between -6.00 and -8.00 diopters. Examinations carried out at 1, 3, 6, 12, 36 months • Exams included • Topography • Corneal pachymetry • Tonometry Hjortdal JO, Moller-Pedersen T, Ivarsen A, Ehlers N.Corneal power, thickness, and stiffness: results of a prospective randomized controlled trial of PRK and LASIK for myopia. J Cataract Refract Surg. 2005 Jan;31(1):21-9

  12. Results • Near term IOP is lowered more following LASIK versus PRK even though corneal thickness decreased significantly less in LASIK eyes than in PRK eyes • Long term (3 years) the corneal thickness is the same in two groups but the IOP is significantly lower in LASIK patients • This would support that the difference in IOP following corneal surgery is not a result of changes in corneal thickness

  13. Correlation LASIK-IOP • A study on 8113 consecutive eyes following LASIK • Regression analysis demonstrated a reduction of 0.12 mm Hg per diopter of refractive change which theoretically would be related to changes in corneal thickness • Extrapolation to “zero” diopters shows a reduction of 1.36 mmHg which cannot be related to the change in corneal thickness • Data supports an additional mechanism, independent of corneal thinning, which leads to an IOP reduction DH Chang, R. Doyle Stulting. Change in Intraocular Pressure Measurements after LASIK. Ophthalmology 112,6,June 2005

  14. Additional Change in IOP

  15. Exact Relationship of Corneal Thickness to IOP is Unknown • It is accepted measurements underestimate IOP with thinner corneas and overestimate IOP with thicker corneas • It is unknown whether the relationship between corneal thickness and IOP in the general population is linear or non-linear across the range of naturally occurring thicknesses • It is unknown whether a cornea thinned by LASIK has the same implications in terms of tonometric artifacts as does a naturally thinned cornea Samuelson TW. Refractive surgery in glaucoma. Curr Opin Ophthalmol. 2004 Apr;15(2):112-8

  16. PNT Procedure

  17. Indications • Patients 18 years of age or older • Patients with: • Primary open angle glaucoma (POAG) • Pigmentary glaucoma (PG) • Glaucoma secondary to pseudoexfoliation of the lens capsule (PXG) • Eyes with moderate ocular hypertension (OHT), defined as any non-glaucomatous eye with an IOP in the range of 22-25 mm Hg • With or without concomitant medication

  18. Contraindications • Chronic iritis/uveitis in either or both eyes • History of secondary glaucoma in one or both eyes • History of penetrating keratoplasty (corneal transplants), diabetes with rubeosis iridis, severe cupping (90% to complete; excavation), narrow angles and/or moderate to extensive visual field changes (i.e., only a central island of vision (advanced visual field loss within 10 degrees of central fixation as determined by automated perimetry) in either or both eyes. • Moderate visual field defect • Macular degeneration (wet or dry) in either or both eyes • Patients who have undergone a surgical trabeculectomy. Prior ATL and SLT procedures are not considered to be contraindications • Patients with keratitis • Patients whose angles are not fully open (i.e. narrow angle, atypical angle, closed angle). • Patients with severe dry eye syndrome associated with Fuch's Corneal Dystrophy • Patients with corneal abnormalities or corneal disorders • High Myopia defined as myopsis in excess of 6 diopters

  19. The Equipment • A patented 3-port design allows for equal vacuum to be applied throughout the perimeter, essential for achieving consistent IOP reduction • The ring is single use, prepackaged as sterile and ready for use • The ring is connected to a microprocessor controlled vacuum pump which is activated using a unique barcode

  20. PNT Procedure • topical anesthesia • 60 sec application • 5 minutes off • repeat 60 sec application • re-treat at 1 week • start reduction of meds at3-4 weeks • re-treat in 3-4 months

  21. Summary of Clinical Experience

  22. Clinical Trials • Bucci • Avalos and LiVecchi • Bores • Ceruti-Marchini-Marraffa • Brogioni-Borgia • Dorigo-Bandello-Roman • Prigione-Rolando-Calabria • Offermann-Augustin

  23. Pilot Study to Evaluate Efficacy and Safety of Pneumatic Trabeculoplasty (PNT) in Glaucoma and Ocular Hypertensive Principle Authors: Prof. Massimo G. Bucci, M.D. Marco Centofanti, M.D. Francesco Oddone, M.D. Mariacristina Parravano, M.D. Prof. Corrado Balacco Gabrieli, M.D.José Pecori-Giraldi, Ph.D. Aloisa Librando, M.D. Emanuele Paone, M.D. Leo D. Bores, M.D. Eur. J. Ophthal., 15(3), 2005 pp 347-352. Monotherapy Trial

  24. Bucci Trial Design • Purpose: To independently determine the IOP lowering effect of PNT • Prospective, open-label fellow eye trial in POAG and OH patients performed in 2 glaucoma centers in Italy • Patients on glaucoma medication willing to stop treatment and undergo adequate washout • IOP between 22-28 mm Hg on Day 0 • Extensive ocular examinations and safety monitoring • Duration of trial 120 days

  25. Mean Change in IOP For In-Study SubjectsItalian Monotherapy Trial

  26. % IOP Reduction

  27. Result From Monotherapy Trial • 73% (27/37) showed a PNT (pressure lowering) response and completed study • Four of the 10 dropouts were due to issues not associated with PNT procedure • No patients withdrew due to intolerability of procedure • A 15% reduction in IOP was achieved by approximately 50% of patients during the study period • No significant adverse events observed. All events resolved without medical intervention

  28. PNT – Combination Therapy and Ability to Reduce Medication Requirements • “Pneumatic Trabeculoplasty (PNT) – A new method to treat primary open-angle glaucoma (POAG) and reduce the number of concomitant medications” • G. Avalos Urza, M.D.John T. LiVecchi, M.D. Leo Bores, M.D., Ann. Ophthalmol. 2005; 37(1),pp. 37-46.

  29. Compilation of data from two separate trials involving PNT • Drs. Avalos and LiVecchi – First studies were performed at Dr. Avalos’s clinic to evaluate the potential of PNT to lower IOP in patients on existing medication • Dr. Bores – Study was performed at the Arizona Glaucoma Institute, to evaluate the potential of PNT to reduce medication requirements while maintaining IOP control

  30. Study By Avalos and LiVecchi • Purpose: To test hypothesis that PNT can provide a clinically significant decrease in IOP 177 patients; 320 eyes treated • Duration of trial 6 months • Outcomes in PNT patients were compared to a historical cohort of patients, during the same time period, who were on meds alone

  31. Summary of IOP ResultsAvalos and LiVecchi

  32. Observed Reduction in MedicationAvalos and LiVecchi # of patients 19 eyes went on to require filtering procedures, 5 of these being those with capsular exfoliation and 1 with recessed angle due to trauma

  33. Comparison of Medication Requirements Avalos/LiVecchi Pre-PNT Post-PNT

  34. Observed Side EffectAvalos and LiVecchi • Side Effects from PNT procedure were generally considered minor, resolved without medical intervention and included • Mild conjunctival edema and injection • Subconjunctival hemorrhage • Mild discomfort • No serious sight threatening complications and no visual field deterioration or retinal nerve damage were observed (VF analysis)

  35. Arizona Glaucoma Institute • Study was undertaken by Leo D. Bores, M.D., beginning in the fall of 1997 • 320 eyes (165 patients) • Mean follow-up was 14 months (Longest was 24 months) • Outcomes compared to a historical cohort of patients treated during the same period at the same institution

  36. Summary of IOP Results Bores Initial IOP 16 – 48 mm HG

  37. Reduction in Study MedicationBores @ 3 months • Again, a shift towards fewer number of concomitant meds was observed post-PNT • Majority of patients required 0 or 1 medication following PNT to maintain safe IOP

  38. Observations From Results Observed In Avalos/LiVecchi and Bores Studies • PNT can achieve good IOP control with a significant reduction or elimination of concomitant medications • The PNT effect is ‘reproducible’. When IOP drifts upwards in a patient who has responded to PNT a repeat application will again reduce the IOP • No safety issues were observed which would prevent using PNT in the glaucoma or ocular hypertension patient

  39. Efficacy of Pneumatic Trabeculoplasty in Primary Open Angle Glaucoma • Dr. P. Ceruti, et.al., Department of Neurological and Visual Sciences, University of Verona, Verona, Italy • Presented – 2006 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) • The Study – Prospective 14 patient study, 120 days in duration, to determine the IOP lowering effect of PNT in patients not adequately controlled on anti-glaucoma medication. All patients received comprehensive ophthalmic monitoring, including Ultrasound Biomicroscopy examinations. Starting IOP was 22 ± 1.8 mm Hg • Results: A statistically significant reduction of greater than -15%, with a maximum -21% on day 8, was observed for the entire study. UBM analysis supports the apparent mechanism of action being the restoration of trabecular outflow.

  40. UBM • Examinations performed pre and post PNT • ACD (Anterior Chamber Depth) • SCPA (Scleral Ciliary Process Angle) • CBT (Ciliary Body Thickness)

  41. UBM Parameters SCPA 1000

  42. UBM Results • ACD and SCPA: No significant variation pre and post PNT SCPA ACD

  43. Results of UBM • Reduction in Ciliary Body Thickness (CBT) following PNT (p<0.05) a 1000 µm from the scleral spur sperone sclerale sperone sclerale 2500 2000 1500 1000 2500 2000 1500 1000

  44. Results • Increase in uveoscleral reflectivity following PNT

  45. Efficacy of Pneumatic Trabeculoplasty in Primary Open Angle Glaucoma • Brogioni, C. et. al., Dip.di Medicina e Scienze dell’Invecchiamento Università di Chieti • Published – Boll. Ocul, 85 (3), 2006, pg 253-256 • The Study – Prospective 20 patient study, 120 days in duration, to determine the IOP lowering effect of PNT in patients not adequately controlled on prostaglandins (10) or beta-blockers (10). All patients received comprehensive ophthalmic monitoring, including Ultrasound Biomicroscopy examinations. Starting IOP was 22 ± 1.8 mm Hg • Results: 17% drop in IOP observed for both groups. 33% reduction in “oscillations” from 3.6 +/- 0.62 to 2.4 +/- 0.5 mm Hg. UBM results consistent with those of Ceruti et. al.

  46. Change in Angle following PNT

  47. Change in Mean IOP

  48. Dorigo-Bandello-Roman (part of multicenter trial )Università di Padova • Primary objective: To verify the reduction in IOP • Secondary objective: to determine impact on Central Vision, RNFL and C/D ratio • PNT Treatments on days 0 and 7. Additional visits on 1, 8, 14, 30, 60, 90 and 120 • 10 patients with POAG • Follow up 12 months for final pathology

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