Publications by authors named "Gary Novack"
Treatment of ocular diseases presents unique challenges and opportunities for the clinician and for the clinical pharmacologist. Ophthalmic pharmaceuticals, typically given as liquids, require consideration of solubility, physiological pH, and osmolarity, as well as sterility and stability, which in turn requires optimal pharmaceutics. Ocular tissue levels are challenging to obtain in humans, and the clinical pharmacokinetics is typically blood levels, which are primarily related to safety, rather than efficacy.
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- A Phase 3 study evaluated the safety and efficacy of AG-920, a new topical ocular anesthetic, in children compared to proparacaine during eye examinations.* -
- The study involved 60 healthy pediatric subjects and found that AG-920 allowed successful eye examinations without the need for extra anesthetic, with no adverse events reported.* -
- Results showed AG-920 was therapeutically equivalent to proparacaine, indicating it is a safe and effective option for use in pediatric patients undergoing ophthalmic procedures.*
Purpose: To assess safety and ocular hypotensive efficacy of VVN539 ophthalmic solution in a first-in-human study.
Design: Multicenter, double-masked, randomized, vehicle-controlled, dose-response, parallel-comparison study.
Participants: Sixty-eight subjects with ocular hypertension (OHT) or open-angle glaucoma enrolled at 5 private practices.