Gary Novack

Gary Novack
PharmaLogic · R&D

Ph.D.

About

289
Publications
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5,726
Citations

Publications

Publications (289)
Article
Purpose Phase 1 / 2 evaluation of H-1337 Ophthalmic Solution in Subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Design This was a phase 1/2, randomized, double-masked, vehicle-controlled, dose-response study. conducted at 6 private practice sites in the United States. Participants Enrolled were 87 subjects with bilat...
Article
In our University journal club we discussed a large, retrospective study of cataract surgery endophthalmitis rates before and after instituting the use of an intracameral fluoroquinolone antibiotic. We identified several factors involved in the use of off-label, compounded moxifloxacin in intraocular surgery. The introduction of phacoemulsification...
Article
Introduction: Currently, the only modifiable risk factor to slow or halt the progression of glaucoma is the lowering of intraocular pressure (IOP). Netarsudil 0.02% is a new medication that was approved by the U.S. FDA in 2017 for reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Areas covered:...
Article
The ideal biomarker would be a simple laboratory or clinical evaluation before treatment, which would predict subsequent therapeutic response. This might include selection of which patients might respond to that treatment. While other disciplines such as neurology and oncology have biomarkers, ophthalmology is limited to one-elevated intraocular pr...
Article
Full-text available
Purpose: To evaluate netarsudil 0.02% ophthalmic solution in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). Design: Double-masked, randomized, multicenter, parallel-group, noninferiority clinical study. Methods: After a washout of all prestudy ocular hypotensive medications, 756 eligible patients with elevated IOP were...
Chapter
Cell therapies present many unique challenges to regulators. The science is continuing to advance. Cell replacement therapy is part of the Audacious Goals Initiative of the U.S. National Eye Institute, and viewed as having great promise in restoring vision through regeneration (Levin et al., Ophthalmology 124:926–934, 2017). However, the risks to p...
Article
Because of the epidemic of myopia with both its short-term and long-term effects, we desperately need ways to slow myopic progression. In this study which was part of a myopia prevention symposium, the author answers the following question: Assuming that researchers did come up with a pharmacological treatment to slow myopic progression-what would...
Article
Full-text available
Purpose: Netarsudil, an inhibitor of Rho kinase and a norepinephrine transporter, has been shown to lower elevated intraocular pressure (IOP) in controlled studies of patients with open-angle glaucoma and ocular hypertension, and in healthy volunteers. The mechanism of this ocular hypotensive effect in humans is unknown. Methods: The objective o...
Article
Full-text available
Purpose: To evaluate the efficacy and ocular and systemic safety of netarsudil 0.02% ophthalmic solution, a rho-kinase inhibitor and norepinephrine transporter inhibitor, in patients with open-angle glaucoma and ocular hypertension. Design: Double-masked, randomized non-inferiority clinical trials. Methods: After a washout of all pre-study ocu...
Article
Introduction: Glaucoma is the second leading cause of blindness in the world and current pharmacotherapies for glaucoma have remained relatively unchanged (with the exception of fixed combinations of previously available medications) since the mid-1990s with the development of prostaglandin analogues. Now, with both new formulations and new classes...
Article
This article presents an Executive Summary of the conclusions and recommendations of the 10-chapter TFOS DEWS II report. The entire TFOS DEWS II report was published in the July 2017 issue of The Ocular Surface. A downloadable version of the document and additional material, including videos of diagnostic and management techniques, are available on...
Article
The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective...
Article
Purpose of review: To discuss recent advances in the medical management of glaucoma and to highlight future medical therapies currently in development. Recent findings: In 1996, latanoprost (Xalatan) was approved in the United States as a new chemical entity and new class (prostaglandin analogs) for the topical treatment of ocular hypertension a...
Article
Purpose: To evaluate the cost paid by patients in the U.S. for their branded, prescription medication, and the factors that determine the cost DESIGN: Evaluation of publicly available information on the U.S. pharmaceutical distribution system. Methods: Review of public information and interpretation based upon the author's experience. Results:...
Article
Purpose of review: The purpose of this article is to review the current status of cannabis in the treatment of glaucoma, including the greater availability of marijuana in the USA. Recent findings: The potency of marijuana, as measured by the concentration of Δ-tetrahydrocannabinol, has increased from ∼2 to 3% in the 1970s to ∼20% today. Many US...
Article
Planning the nonclinical development program for an ophthalmic product requires first an understanding of how the drug will be used in the clinic–topical, injected, relatively short duration of testing, chronic testing, and what is already known about the drug. In some cases, when the drug is being repurposed or reformulated to allow for the same o...
Article
Ophthalmic diseases include those both analogous to systemic diseases (e.g., inflammation, infection, neuronal degeneration) and not analogous (e.g., cataract, myopia). Many anterior segment diseases are treated pharmacologically through eye drops, which have an implied therapeutic index of local therapy. Unlike administering pills for systemic dis...
Article
Background/aims To evaluate the ocular hypotensive efficacy of fixed-dose combinations of the Rho kinase inhibitor and norepinephrine transport inhibitor AR-13324 (0.01% and 0.02%) and latanoprost (PG324 Ophthalmic Solution) relative to the active components AR-13324 0.02% and latanoprost 0.005%, used bilaterally at night. Methods This was a double...
Article
Objective: AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter. The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control, latanoprost ophthalmic solution, in patients with open-angle glaucoma (OAG) or ocular hyper...
Article
Glaucoma is a chronic progressive optic neuropathy that is characterized by optic nerve changes and visual field loss. Elevated intraocular pressure (IOP) is the main modifiable risk factor. Chronic instillation of daily eyedrops to lower IOP is the primary treatment of choice, although it requires patient adherence and correct performance. We have...

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Projects (2)
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Archived project