TFDA has officially approved ologen™ Collagen Matrix; this marks another chapter for ologen, along with more than 40 countries which are currently facilitating ologen treatments.
A long-term study conducted in South Korea with a total of 26 areas of 25 eyes in 25 patients were carried out. Post-operative follow-up of 8-12 months concluded that no eyes showed recurrence or specific complications related to Ologen such as implant extrusion or allergic reaction. Minor complications such as flap vessel engorgement and flap hypertrophy were easily treated.
Han et al. concluded that the combined surgery of may be an effective and safe procedure for the treatment of scleromalacia after periocular surgeries.
Citation: Han et al. Conjunctival Flap with Biodegradable Collagen Matrix Implantation for the Treatment of Scleromalacia after Periocular Surgery. Ocular Immunology & Inflammation, 2018; 00(00): 1-8.
Funding: The authors reported no conflict of interest in the completion of this study.
This study included a total of 20 eyes of 20 glaucoma patients, who were followed for at least 1-year after undergoing AGV implantation. In 12 eyes of 12 patients, conventional AGV (CAGV) surgery was performed, while in 8 eyes of 8 patients, ologen-augmented AGV (OAGV) implantation was performed.
The rate of complete success was significantly higher in the OAGV group (50.0%) than in the CAGV group (8.3%).
Surgeries with ologen implantation show encouraging results for patients with refractory glaucoma, specifically with respect to the achievement of complete success and the reduction of the number of IOP-lowering medications during the early hypertensive phase.
Citation: Kim et al. Comparison of 1-year outcomes after Ahmed glaucoma valve implantation with and without ologen adjuvant. BMC Ophthalmology, (2018) 18:45.
Funding: The authors reported no conflict of interest in the completion of this study.
A Recent 2-year retrospective study shows glaucoma patients in Japan benefiting from the usage of ologen™ collagen matrix in surgery. 7 patients with post-surgery ocular hypotony regained control of their eye pressure and glaucoma medication needs after intervention with collagen matrix assisted bleb revision.
ologen™ CM Patch Grafts Improve Ahmed Valve Treatment Success Rates by 127%
According to a new 6-month Korean study published in the journal Investigative Ophthalmology & Visual Science, success rates of Ahmed Glaucoma Valve (AGV) surgeries soar and post-operative anti-glaucoma medication needs drop when said surgeries are performed in combination with biodegradable collagen patch grafts (commercially available as ologen™ CM).
Consisted of more than 90% atelocollagen, ologen™ CM is biodegradable and commercially available in dry form. It serves as a three-dimensional micro-scaffold that not only buffers the ocular aqueous flow but also encourages conjunctival fibroblasts to grow into its structure for healthy tissue formation.
Of the 43 AGV implantations performed, 22 were aided with patch grafts composed of biodegradable collagen. Those aided with the patch grafts see significantly healthier blebs, higher 6-monthtreatment success rate as well as lower dependence on anti-glaucoma medications for at least 6 months post-operation. These results can mean significantly improved life quality for many glaucoma patients undergoing AGV treatmentsand less drain on precious medical resource.
Aeon Astron Europe, the manufacturer of ologen™ CM is excited to learn of the new publication and believes it will help ologen™ CM in gaining approval for thepatch graft indication. The company expects the results of this study and others to be the incubator for more research interest to grow as well as more indication approvals to come.
Citation: Rho, S., Sung, Y., Ma, K., Rho, S., & Kim, C. (2015). Bleb Analysis and Short-Term Results of Biodegradable Collagen Matrix–Augmented Ahmed Glaucoma Valve Implantation: 6-Month Follow-up. Investigative Opthalmology & Visual Science Invest. Ophthalmol. Vis. Sci., 56(10), 5896-5896.
Funding: The authors reported no conflict of interest in the completion of this study
5-Year MMC vs. ologen™ CM Study finds the latter with 37% Higher Success Rates
A new study published in the Journal of Ophthalmology in May finds that using collagen matrix implants (available commercially as ologen™ CM) in place of mitomycin C (MMC) can significantly increase the long-term (5 year) success rates of open-angle glaucoma treatment via trabeculectomy for Chinese patients.
A total of 63 eyes – a significantly high number of test subjects for trabeculectomy studies – received randomized treatments of either trabeculectomy with ologen™ CM or trabeculectomy with MMC. Eye pressure (IOP), eye tissue health, post-operative complications and other indicators were measured, analyzed and tracked regularly for five years, which makes it a milestone – the longest follow-up study on the subject to date.
Trabeculectomy is the current gold standard of glaucoma surgical treatments. Aeon Astron Europe, the manufacturer of ologen™ CM, is encouraged by the extremely positive results of this 5-year study. Large-scale and long-term studies such as this are important additions to an increasing body of evidence that collagen implants with anti-fibrotic functions may outperform anti-metabolite agent MMC in primary open-angle glaucoma treatments.
The company anticipates more research interests to ensue as multiple trabeculectomy-collagen matrix trials worldwide begin conclude in the near future. They are expected to yield the same powerful long-term care results in support of the increasing adoption of the collagen matrix.
Citation: Yuan, F., Li, L., Chen, X., Yan, X., & Wang, L. (n.d.). Biodegradable 3D-Porous Collagen Matrix (ologen™) Compared with Mitomycin C for Treatment of Primary Open-Angle Glaucoma: Results at 5 Years. Journal of Ophthalmology, 2015, 1-7.
Funding: The authors have no proprietary or commercial interest in any materials discussed in this paper.
A meta-analysis on ologen™ Collagen Matrix vs MMC in Trabeculectomy to be highlighted at the 2014 AGS Exhibit
A meta-analysis on ologen™ Collagen Matrix vs. MMC in trabeculectomy by Miao He et al. (2014) will be highlighted during the exhibit of AAE at the 2014 AGS, Washington DC at Omni Shoreham Hotel from Feb 27 – Mar 1. We sincerely welcome your visit at our booth T12.
The meta-analysis with the inclusion of the seven (7) RCTs including 227 eyes has shown that the WMDs (weighted mean difference) in IOP reduction between the ologen™ group and the MMC group in trabeculectomy were not significantly different in the follow-up period of 3m, 6m, 24m; the complete/qualified success rates (defined as post-op IOP < 21 mmHg w/o Rx; w/ or w/o Rx) of the two groups were also comparable at all time points. The meta-analysis reconciled the differences in the interpretations of the RCTs in terms of analyzing the absolute IOP vs. the reduction in IOP (which should be the case as a set of pre-/post-op IOP is considered paired data) by conducting a series of sensitivity tests, assessing for the review quality (kappa test), testing for publication bias (funnel plot and Egger’s test) and adjusting for study heterogeneity (a random effect model despite no Chi-square, I-square test findings) according to a good review practice (the Cochrane Reviewer’s Handbook and the PRISMA).
Further large-scale RCTs from the US and RCTs with follow-up up to 5 years from the EU are expected to be presenting at the “ologen™ Lunch Symposium” (Apr 3; Hall D5) at the 2014 WOC Tokyo from Apr 2 – Apr 5 along with the other topics of the novel application of ologen™ Collagen Matrix in bleb revision surgery and the repair of scleromalacia. We are also looking forward to meeting you at the April event.
New Horizons: “Novel Applications for ologen™ Collagen Matrix” at the 5th WGC, July 2013, Vancouver, Canada
The Aeon Astron sponsored symposium “New Horizons: Novel Applications for ologen™ Collagen Matrix” held at the fifth World Glaucoma Congress, Vancouver, met with great success.
The symposium featured the US experience with ologen™ Collagen Matrix (Dr David Godfrey, Glaucoma Associates of Texas, USA), the combined Ex-Press®-ologen™ CM technique (Dr. Steven Vold, Vold Vision, Arkansas, USA) and an overview of the surgical options for bleb revision surgery using ologen™ CM (Dr. Ronald Fellman, Glaucoma Associates of Texas, USA). Dr Nigar Hasanova of the National Center of Ophthalmology, Azerbaijan and Dr. Maria Moussalli, Hospital Italiano de Buenos Aires, Argentina presented case reports on respectively congenital glaucoma and non-penetrating deep sclerectomy (NPDS).
Dr. David Godfrey opened the symposium by reviewing the physical mechanisms of ologen™ Collagen Matrix which reduce scarring and maintain surgical success post trabeculectomy. He presented the surgical pearl relating to the trimming of the edge of the collagen matrix and placing it a couple of millimeters back from the limbus, in order to create a more posterior bleb when a fornix-based technique is implemented. Dr. Steven Vold of Vold Vision, Arkansas, shared the opinion that the collagen matrix may allow surgeons to shape the bleb appearance and create a healthy vascular bleb. Having an anti-scarring efficacy similar to MMC, the collagen matrix can be applied in combination with other glaucoma filtration devices, such as the Ex-Press® shunt to obtaina controlled outflow of aqueous humor and a minimally penetrating, simple, and precise surgical procedure.
In the retrospective series of 67 eyes treated at the Glaucoma Associates of Texas, where Dr. Godfrey and Dr. Fellman practice, the IOP of the trabeculectomy group with ologen™ CM (44 eyes) went from 20.5 (SD 7.2) mmHg pre-operatively to 11.6 (SD 2.9) mmHg at month 12 post-operatively. Throughout this 12-month follow-up period the patients showed a consistent and well controlled IOP with a stable visual acuity.In the combined phaco emulsification – trabeculectomy group with ologen™ CM (23 eyes), the IOP moved from 14.3 (SD 3.8) mmHg pre-operatively to 11.7 (SD 3.8) mmHg at month 12 post-operatively. At month 18, the cumulative proportion of surgical success was 91.1%*. According to Dr. Godfrey, with comparable results to the MMC-augmented trab, the collagen matrix augmented trab has the potential “to alleviate the long-term side effects typically associated with MMC”.
Dr. Ronald Fellman discussed the use of ologen™ Collagen Matrix in the treatment of refractory bleb dysesthesia and its options for bleb revision surgery. Whilst the traditional method is to revise and resurface the painful bleb using an autologous conjunctival patch (autologous conjunctival bleb resurfacing; ACBR), a second and more recent option could be bleb reduction with the use of ologen™ collagen matrix and subsequent conjunctival advancement. In comparison to ACBR, this method may avoid creating another conjunctival wound at the inferior part of the eye and, as some other surgeons also have proposed, may prevent bleb leak or further hypotony after bleb revision. However, in some of his younger patients, Dr. Fellman, based on the individual’s anatomy and conditions, tends to excise the bleb and close the fistula with a patch graft followed by the implantation of a glaucoma drainage device. The ologen™ Collagen Matrix can be added to the tool kit of an ophthalmic surgeon and may be successfully applied in bleb revision, tube revision, and as patch graft.
Dr. Nigar Hasanova, Azerbaijan, presented a number of case reports on combined trabeculotomy-trabeculectomy (CTT) with ologen™ Collagen Matrix in congenital glaucoma. The collagen matrix offers an attractive opportunity for pediatric surgeons to enhance the surgical success in young patients, where adjuvants such as MMC are usually not recommended. In 10 eyes of children aged between 1-14 months, the IOP was 40.4 (SD 6.87) mmHg preoperatively and 13.4 (SD 1.84) mmHg at the last post-operative visit (follow-up range: 3-6 months). The ologen® CM augmented CTT has received good results even in difficult cases including aniridia, neurofibromatosis type I, and CHED type II.
In conclusion, Dr. Maria Moussalli, Argentina, summarized the application of ologen™ Collagen Matrix in trabeculectomy and non-penetrating deep sclerectomy (NPDS). Using a variety of options to position the collagen matrix, Dr. Moussalli – as Dr. Vold – achieved good results by placing the matrix posterior to the (loosely closed) scleral flap. This, despite the more common surgical guideline to put the collagen matrix on top of the scleral flap. Applications and results obtained with ologen™ Collagen Matrix are constantly evolving and may lead to more novel surgical options, combinations and guidelines. For instance as an anti-scarring device in various eye surgeries and eye tissue repair, such as subscleral placement,,, subscleral-to-subconjunctival drainage placement of the material, scleral reinforcement etc.
India as leading country in the application of ologen™ Collagen Matrix and its combined use
2013 APAO-AIOS symposia recognize India as leading country in the application of ologen™ Collagen Matrix and its combined use with other compounds.
The Aeon Astron sponsored symposium at the 2013 APAO-AIOS Joint Congress1 “Breakfast Debate: ologen™ Collagen Matrix or MMC for Glaucoma Surgery? (GL-SP01)” recognizes India as leading country in the application of ologen™ Collagen Matrix and its use in combination with other compounds. Followed by Dr. Robert Ritch’s scientific program on: “The Use of ologen™ in Filtration Surgery (GL-SS08)”, the debate further introduced to a video-assisted skill transfer presented by AIOS and ISGS2 “Trabeculectomy: Pearls & Pitfalls; Cipla” in which the collagen matrix implant was recommended by a number of highly recognized Indian members of the national presenting panel3,4,5. According to the audience’s response, a large number of the attendees were convinced of the outstanding qualities ofologen™ Collagen Matrix and willing to try or continue using the collagen matrix.
Dr. L Vijaya opened the debate by reviewing the phases of wound healing and the role of Mitomycin-C (MMC) in glaucoma filtration surgery. As MMC-associated complications are dose-dependent, Dr. Vijaya recommended an application with the minimal required dose of MMC with the shortest exposure time possible, as opposed to a localized, high-dose MMC implementation.
In response, Dr. B S Rao brought up the aspect of ologen™ Collagen Matrix implant as an anti-scarring adjuvant and alternative to MMC: with physiological wound modulation and the prevention of wound adhesion and formation of dense scarring, the collagen matrix implant may reduce the chemo toxic hazard – both for the patients and for the surgeons – of applying and disposing of MMC.
In the second round of the debate, Dr. Sathyan P and Dr. Sirisha S reviewed the clinical evidence available to date. In a two-year randomized controlled trial (RCT) by Dr. Cillino et al. (2011), ologen™ Collagen Matrix was used as an adjuvant in trabeculectomy. In agreement with Aravind Eye Hospital’s experiences presented by Dr. Sathyan at the debate, the study tentatively concluded that “The implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.”
More RCT’s were reviewed with regard to the MMC use. Despite the more-established effectiveness in killing cells and the non-conclusive results on MMC’s safety issues, a number of studies do suggest that MMC may increase the chances of post-operative complications. This safety issue is especially significant in treating young patients as “the bleb-related complications are going to be more… the longer you follow them up. (Dr. Sirisha)”*6 A solution to the unmet need for the optimization of filtration surgery – especially in pediatricglaucoma – was yet to be found.
The debate peaked when a new application modality of the ologen™ Collagen Matrix was discussed: the pros and cons of combining collagen matrix implant with low-dose MMC (separate procedures; 0.1 mg/mL MMC or below; in comparison to the commonly used dose of 0.2 mg/mL up) and whether there would be conflicting mechanisms. While ologen™ Collagen Matrix alone may be enough in general situations as proven by the evidence, the implant and the antimetabolites may nevertheless be active during the different phases of wound healing and thus achieving some kind of synergism for scar prevention. This especially could be the case in patients requiring more complicated care, for instance, during repeated or revision surgery post failed trabeculectomy. Some preliminary reports have been published by Dr. Dada et al. (J Glaucoma 2012), Dr. Bordeianu (ESCRS abstract, 2012), Dr. Rosentreter et al. (2010) and Dr. Kohlhaas (2012; 2008), supporting the idea of this combined use of a collagen matrix and an anti-metabolite in the special cases.
To summarize, the combined use of ologen™ Collagen Matrix implant with low-dose antimetabolites (separate procedures) raises the question as to how low an effective dose of MMC could be in order to obtain the desired results with optimal wound healing and reduced bleb-related complications. Further research is also required for new possible combinations, such as the effectiveness of ologen™ Collagen Matrix together with Bevacizumab (separate procedures)7, an anti-VEGF adjuvant presumably suitable for glaucoma surgery patients with AMD or neovascular glaucoma. The exploration of these approaches may help optimize the practice of filtration surgery as well as other glaucoma related surgeries (GDD, revision surgery and NPGS), when a delicate consideration is made between the welfare of patients with more difficult glaucoma situations and the economy of health care.
(Click to see the photos of the events.)
1. Asia Pacific Academy of Ophthalmology (APAO) and All India Ophthalmological Society (AIOS) Joint Congress
2. International Society of Glaucoma Surgery (ISGS)
3. Dr. Murali Ariga (Swamy Eye Clinic and Chennai Glaucoma Foundation) on “Same site phacotrab with ologen implant”.
4. Dr. R Ramakrishna (Aravind Eye Hospital; author, co-editor of “Diagnosis & Management of Glaucoma, Jaypee 2013”) on “Trabeculectmy with ologen”.
5. Dr. Tanuj Dada (Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS; ISGS) on “Trabeculectomy with ologen subconjunctival & subscleral (with subscleral crater)”, “ologen subconjunctival with releasable sutures”, “ologen subslceral (NPDS with low-dose MMC; separate procedures)”.
6. Some abstracts on the application of collagen matrix implant in pediatric glaucoma are to be presented in 2013 SOE, Copenhagen, and 2013 WGC, Vancouver.
7. Other candidates include Ranibizumab, Aflibercept, or small molecular anti-VEGF (TKI), such as Pegaptanib (soaked or intraocular injection).
EuroTimes And EyeWorld News on ologen™ Collagen Matrix
ologen™ Collagen Matrix as An Alternative to MMC And The Patch Grafts in Glaucoma Surgery
The monthly magazine of ESCRS1, EuroTimes (Vol 17; 11, Nov 2012), and the official news magazine of ASCRS2, EyeWorld (Vol 17; 9, Sept 2012), cover the news on ologen™ Collagen Matrix implant, featuring the interviews with Dr. Sarkisian on the applications of collagen matrix implant as a promising alternative to MMC in glaucoma surgeries. The article (EuroTimes) also provides valuable insights on the trends in the discovery of collagen matrix implant applied as ophthalmic patch grafts in recent years.
Without the chemo toxic hazard of handling and applying MMC in glaucoma surgeries, “the implant inhibits scar formation by acting as a spacer and prevents the fibroblasts from laying down in organized fashion,” said Dr. Sarkisian (EuroTimes). “I now use it in 90% of my patients,” he added. Dr. Sarkisian is glaucoma fellowship director at the Dean A McGee Eye Institute and clinical associate professor at the University of Oklahoma in Oklahoma City, USA.
The exceptions, however, may include patients with thicker Tenon’s capsules, who may require MMC in filtering surgeries due to high tendencies to scarring (EuroTimes). The surgical tips provided by Dr. Sarkisian not only point to the possibility and necessity of considering patient’s risk factors, such as secondary glaucoma or a history of failed glaucoma surgery, for surgical adjustments, but also offer guidance as to how to treat ologen™ patients differently from those receiving MMC, in either surgical practice or study design.
“This means not using three to seven sutures in the flap and not trying the sutures too tightly. ologen™ will tamponade the flap (to prevent hypotnoy) if it is placed correctly. It is also important NOT to wait three weeks before cutting the sutures,” suggested Dr. Sarkisian (EuroTimes). An early and flexible suture lysis/ release BEFORE the timing of postoperative pressure target being reached is the secret to a better controlled surgical outcome and even less chance of having to do needling.
In the issue of EuroTimes, Dr. Sarkisian also previewed a retrospective study where he uses ologen™ Collagen Matrix together with the ExPress glaucoma shunt (Alcon Lab). “Trabeculectomy with the ExPress glaucoma shunt and ologen™ found a qualified success rate of 94.4 per cent at 12 months in 36 eyes,” he said. The results of the new glaucoma drainage device surgery seemed to be better achieved with ologen™Collagen Matrix where the average postoperative pressure was 12.1 mmHg at 12 months (EuroTimes).
According to a recent review article entitled “Tube Exposure Repair” on JOCGP3 by S Oana, J Vila (2012), ologen™ Collagen Matrix implant serves as a biodegradable, synthetic patch graft in glaucoma drainage device (GDD) surgery and revision surgery, leaving in its wake the patient’s own connective tissue in an average of 180 days. Collagen matrix implant may be a safer and more economic alternative to the traditional autologous/heterologous donor grafts in GDD and revision surgery due to its synthetic nature. Collagen matrix implant could cost even half the price of some traditional patch grafts. (Read more about ologen™ CM patch graft’s CPT Code information in the US.)
Positive experiences of ologen™ Collagen Matrix as patch grafts in GDD surgery and revision after the erosion or exposure of the GDD’s have also been gained for the Baerveldt tube shunt (Rosentreter et al 2010; 2012) and the ExPress Shunt (B Anguelov 2012; S Vold 2011; Juan A E Campaña et al 2010*4).
More evidence needs to be collected from the cases with Ahmed Valve and Molteno Implant, especially where ologen™ Collagen Matrix may be used to initially cover the drainage implant tube. As with the study of collagen matrix implant with Ex-Press glaucoma shunt, “clearly this needs to be confirmed in further randomized studies with longer follow up,” Dr. Sarkisian concluded (EuroTimes).
1. European Society of Cataract and Refractive Surgery
2. American Society of Cataract and Refractive Surgery
3. Journal of Current Glaucoma Practice, the official publication of ISGS (International Society of Glaucoma Surgery)
4.* Eficacia del Implante EX-PRESS en el Tratamiento del Glaucoma Cronico de Ángulo Abierto; Departament de Cirurgia, Universitat Autònoma de Barcelona; Servicio de Oftalmología del Hospital Universitario Joan XXIII de Tarragona; Sept 2010. Abstract P697 published at 2011 WGC (World Glaucoma Congress), Paris, France.