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Biomedical subjects

Gary D Novack

Publications and source records attributed to Gary D Novack.

29 records · Page 2Linked to original sources
PubMed2003

Long-term results of noncontact neodymium:yttrium-aluminum-garnet cyclophotocoagulation in neovascular glaucoma.

PURPOSE: To determine the long-term efficacy and safety of noncontact transscleral neodymium:yttrium-aluminum-garnet (Nd:YAG) cyclophotocoagulation (CP) for the treatment of neovascular glaucoma (NVG). DESIGN: Retrospective, noncomparative, interventional case series. PARTICIPANTS: One hundred fifteen eyes of 111 subjects treated from December 1987 to January 2001. METHODS: Eyes with uncontrolled NVG underwent noncontact Nd:YAG CP. Treatment parameters and pretreatment and posttreatment intraocular pressures (IOP) were reviewed. Preoperative and postoperative IOP were compared using a paired Student's t test. Success was defined as an IOP </=22 mmHg, with or without medications, in the absence of phthisis bulbi, and without having undergone further surgical procedures. Results were subjected to a Kaplan-Meier life-table analysis. RESULTS: Mean follow-up was 27.0 +/- 34.3 months (range, 1-148 months). Mean preoperative IOP was 47.4 +/- 11.1 mmHg (range, 26-70 mmHg). Mean postoperative IOP was 18.3 +/- 12.2 mmHg (range, 0-44 mmHg). The mean number of treatment sessions was 1.4 +/- 0.7 (range, 1-6), with 82 eyes (71.3%) having only one treatment. Kaplan-Meier survival analysis showed a probability of continued success at 1 year of 65.0%, at 3 years of 49.8%, and at 6 years of 34.8%. Phthisis developed in 8.6% of the eyes. CONCLUSIONS: Noncontact Nd:YAG CP provides long-term IOP reduction in eyes with medically uncontrolled NVG. This can be associated with complications that include inflammation, visual loss, and hypotony. Repeat treatment may be necessary.

Adult↗
PubMed2003

Compliance issues in manufacturing of drugs.

The therapeutic process relies on the assumption that the prescription written by the clinician is what is dispensed to the patient. In this article, we review the many factors involved in the manufacture of pharmaceutical products so that they consistently meet quality standards as approved by regulatory agencies. Industry and government agencies have developed procedures and laws to assure quality in Chemistry, Manufacturing and Controls (CMC) for pharmaceuticals, addressing conditions that may be harmful to patient health. This includes procedures for receipt of materials, production, packaging, labeling, quality control, release, storage and distribution, known as current Good Manufacturing Practice. Special control considerations for ophthalmic products include foreign particulate matter control, preservative effectiveness tests, sterility and leaching of chemicals from the packaging into the product. We also describe the "form, fill and seal" manufacture process as used in unit-dose, non-preserved ophthalmic products; product expiration dates; stages of drug development; and financial considerations for pharmaceutical companies.

Journal Article↗
PubMed2003

Emerging drugs for ophthalmic diseases.

The ocular system is crucial to survival. It is subject to many of the same diseases found in other organ systems (e.g., diabetes) as well as diseases of ageing (e.g., macular degeneration) and other diseases (e.g., myopia). This review describes ocular diseases which are treatable, or potentially treatable, by pharmacological intervention (e.g., glaucoma, ocular infection, ocular allergy, ocular inflammation, dry eye and retinal pathology). Presented is a background of these diseases, the medical need for therapy, and current and potential new treatments.

Animals↗
PubMed2002

New glaucoma medications in the geriatric population: efficacy and safety.

Glaucoma can be considered a disease of the aging eye. Most medications used to treat glaucoma are in topical eyedrop form and may cause numerous untoward systemic effects in older persons. In recent years, several new ocular hypotensive medications have become available. These medications are being used more commonly because there is a growing trend by ophthalmologists to aggressively lower intraocular pressure. Therefore, geriatricians require a comprehensive knowledge of medications used to treat glaucoma, in addition to an understanding of their mechanism of action profiles of untoward effects and possible interactions with other diseases or medications. Therefore, we performed a review of the medications recently introduced into clinical practice. We selected drugs approved by the U.S. Food and Drug Administration between 1996 and September 2001. The safety profiles of these agents and their untoward side effects were reviewed by class: topical carbonic anhydrase inhibitors (brinzolamide: ocular tolerance, taste perversion), beta-adrenoceptor antagonists (timolol: bradycardia and bronchospasm), alpha-adrenergic agonists (brimonidine: oral dryness, headache, and fatigue), and prostaglandin analogs (latanoprost, bimatoprost, travoprost, and unoprostone isopropyl: ocular hyperemia, iris color changes). The function of this review is to make geriatricians more aware of the efficacy and untoward effects of medications recently introduced into clinical practice. We recommend that geriatricians perform a medication review on all medications their patients use, including eye drops.

Adrenergic Agonists↗
PubMed2002

Pharmacologic treatments for dry eye: a worthwhile investment?

PURPOSE: To determine whether investment in a novel pharmacologic agent for the treatment of dry eye would be worthwhile from a financial perspective. METHODS: Estimates were made of the cost and time required to develop a novel pharmacologic treatment of dry eye and the potential revenues for the product. These estimates were used to compute the value of the investment, adjusting for the time value of money. RESULTS: Development was estimated to cost $42 million and to take 55 months from investigational new drug exemption filing to new drug application approval. The potential market for this treatment was estimated at $542 million per year at year 5. Adding in the cost of development and marketing as well as other costs, net present value was very positive at the 5, 8, 10, and 40% cost of financing. The internal rate of return was 90%. CONCLUSION: In summary, if there were a successful pharmacologic treatment of dry eye and if a firm could manage the cash flow during the development, then the market potential approaches that of other treatment of chronic ophthalmic conditions (e.g., glaucoma), and it would be a worthwhile investment.

Chemistry, Pharmaceutical↗