The source of ologen™ collagen matrix is porcine. The lyophilized porcine collagen is extracted from porcine skin with certification of Special Pathogen Free (SPF) in Taiwan.

Collagen from mammals is highly homologous; the difference between porcine, bovine or even human is very tiny. However, human source has contagious disease risk and bovine mainly has BSE concern.

No. Fibroblast will migrate into the porous ologen™ and secrete its own extracellular matrix (ECM) to replace the space after degradation, so there is no scar formation but regeneration process.

ologen™ is in a rigorous production process to guarantee safety and quality. It is under high control by monitoring the quality from the material source to the finished product. The collagen source comes with a certificate of origin and hygiene. The manufacturing process is certified by ISO 9001 and ISO 13485. All collagen devices manufactured have passed biocompatibility testing in accordance with ISO 10993 Biological Evaluation of Medical Devices. Any additional potential concerns such as viruses, BSE, bacteria, and pyrogens have been addressed thoroughly in the manufacturing process control, which includes quality control testing, validations, and risk analyses.

Glaucoma Surgery
▪ Trabeculectomy Surgery
▪ Deep Sclerectomy Surgery
▪ Bleb Revision Surgery
▪ In shunt/Valve Drainage Implants

Other Indications
▪ Strabismus Surgery
▪ Ocular Surface Reconstruction
▪ Eye Plastic Surgery
▪ Grafts Donor Sites
▪ Pterygium Excision
▪ Subconjunctival Scar Revision

As the surgical technique is not changed except adding the implantation of ologen™, no learning curve is required for the surgeon. The instructions for ologen™ are described below:
- Open Angle Glaucoma
Choose one of the following methods with physician’s best clinical judgment and the condition of patient’s anterior chamber.
1.) Suture the scleral flap loosely with a single suture and implant the ologen™ on the top of the scleral flap, then suture the conjunctiva.
2.) The ologen™ can be implanted on top of an unsutured scleral flap and then suture the conjunctiva.
- Angle Closure Glaucoma
Suture the scleral flap loosely with a single suture and implant the ologen™ before suturing the conjunctiva.

ologen™ Collagen Matrix can be applied in pterygium surgery. The ologen™ Collagen Matrix is able to guide fibroblasts to grow randomly into the collagen porous structure during the wound healing process, which reduces the scar formation, avoids further inflammation, and reduces of pterygium reoccurrence.
As the surgical technique is not changed except adding the application of ologen™, no learning curve is required for the surgeon. Simply apply the ologen™ on the top of the exposed sclera or the excision area before suturing.

Scar formation over the trabecular flap and subconjunctival space is the common cause of bleb failure. ologen™ is composed of 3-D collagen–glycosaminoglycan copolymers, which form a porous structure. Instead of using anti-fibrotic agents, the porous structure provides a scaffold for fibroblasts to grow randomly, which could reduce scar formation effectively. And the collagen matrix itself can function like a reservoir to absorb the aqueous humor and provides pressure on the scleral flap to create controlled drainage in the subconjunctival space. The collagen matrix is biodegraded around 90 days depending on the postoperative medication(s), stress tissue site, predetermined intrinsic inflammatory and remodeling mechanisms. ologen™ helps to provide a normalized and functional bleb formation.

Clinically, Mitomycin-C (MMC), 5-fluorouracil, tissue plasminogen activator and corticosteroids are used for the inhibition of fibroblast proliferation to prevent scar development after glaucoma surgery. Unfortunately, the application of antifibrotics to inhibit fibroblasts during or after trabeculectomy usually increases the success rate but induces some severe early and late complications, including wound leakage, corneal toxicity and hypotony maculopathy, bleb leaks, blebitis, and endophthalmitis. Moreover, histopathological examination of blebs after filtering surgery with these agents reveals irregularities in the conjunctival epithelium, breaks in the basement membrane, and hypocellularity of conjunctiva and subconjunctival tissue, each of which may predispose to bleb leaks. Resultant avascular thinning layers of the conjunctiva decrease the defense mechanism and bring the risk of bleb infection and endophthalmitis.

No. ologen™ is not an inhibitor or anti-fibrotic agents. Instead of inhibiting fibroblast proliferation, ologen™ guides the fibroblasts to grow randomly in the collagen matrix through its porous structure. This phenomenon can effectively reduce the scar formation without the complications of anti-fibrotic agents. The normalized wound healing also helps produce functional bleb formation.