<title>Laser sclerectomy and 5-FU controlled-drug-release biodegradable implant for glaucoma therapy</title>

Laser sclerectomy, a simple filtering procedure performed to alleviate high intraocular pressure in glaucoma patients, was taught to offer longer lasting effect and therefore improve the patient's outcome when compared with the standard trabeculectomy procedure. Recent clinical trials have shown that this was not the case and pharmacologic wound healing modulation is also required with this new procedure. Five-Fluorouracil (5-FU) is useful as an adjunct treatment for glaucoma filtering surgery. However, efficacy depends upon maintaining sustained drug levels, currently achieved by repeated daily injection of the drug for several weeks. To overcome this limitation, we designed a biodegradable implant for the sustained release of 5-FU. After laser sclerectomy, the implant is inserted through the same 1 mm wide conjunctival snip incision and positioned below the open channel. Implantation takes less than a minute. The implant releases the drug for over 15 days and totally biodegrades in less than 100 days. The combined laser surgery and implantation procedure show great potentials for the treatment of glaucoma

<title>Noncontact laser penetrating keratoplasty: in-vivo comparative evaluation in rabbit and cat</title>

With their inherent precision and avoidance of tissue deformation, non-contact laser trephines may minimize graft postoperative astigmatism. Laser-cut corneal button geometry surpassed handheld and equaled Hanna and Krumeich vacuum held trephines, without significant endothelium or wound healing differences for linear cuts between laser and metal blades. To compare the laser with metal trephines, we performed 8 mm diameter grafts on 12 rabbits and 12 cats. A new laser system, using an advanced pulsed HF laser coupled to a computer controlled optical delivery system and equipped for quasi-instantaneous simultaneous 8-point corneal marking (200 ns) for precise suture placement at the 5.5 to 10.5 mm diameter and rapid corneal trephination (approximately equals 6 sec), or a new disposable sterile vacuum-assisted Hessburg-Barron (HB) trephine was used in each procedure. Circumferential keratotomies were more accurately and more easily performed with the laser. No statistical differences were found in wound strength and healing. The laser produced a slightly lower astigmatism. These initial results suggest the safety of HF laser corneal marking-trephination and its potential for PK procedures in humans

Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study

Stress testing (also known as forced degradation) of pharmaceutical products has long been recognized as a critical part of the drug development process, providing foundational information related to intrinsic stability characteristics and to the development of stability-indicating analytical methods. A benchmarking study was undertaken by nine pharmaceutical companies and the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, or ANVISA) with a goal of understanding the utility of various stress testing conditions for producing pharmaceutically-relevant chemical degradation of drugs. Special consideration was given to determining whether solution phase stress testing of solid drug products produced degradation products that were both unique when compared to other stress conditions and relevant to the formal drug product stability data. The results from studies of 62 solid dosage form drug products were compiled. A total of 387 degradation products were reported as being observed in stress testing studies, along with 173 degradation products observed in accelerated and/or long-term stability studies for the 62 drug products. Among these, 25 of the stress testing degradation products were unique to the solution phase stress testing of the drug products; however, none of these unique degradation products were relevant to the formal stability data. The relevant degradation products were sufficiently accounted for by stress testing studies that included only drug substance stressing (in solution and in the solid state) and drug product stressing (in the solid state). Based on these results, it is the opinion of the authors that for solid dosage form drug products, well-designed stress testing studies need not include solution phase stress testing of the drug product in order to be comprehensive