Traditional Drug Pipeline Quarterly Update: October 2022
Critical updates in an ever changing environmentOctober 21, 2022
See separate articles for pipeline information on specialty drugs.
New Drug Information
- Omlonti® (omidenepag isopropyl ophthalmic solution) 0.002% eye drops: The U.S. Food and Drug Administration (FDA) has approved Santen’s Omlonti eye drops for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Ocular hypertension, which affects millions of people, can lead to glaucoma and vision loss if untreated. Primary open-angle glaucoma is the most common type of glaucoma. Omlonti is a selective prostaglandin EP2 receptor agonist. Omlonti was approved based on three Phase 3 clinical trials that found the reduction in IOP in the Omlonti group was non-inferior to both timolol and latanoprost treatment groups.1 Omlonti launch, and price are pending.
- Iheezo™ (chloroprocaine hydrochloride ophthalmic gel) 3%: The FDA approved Harrow’s Iheezo for ocular surface anesthesia. Iheezo, an ester anesthetic, is a sterile, preservative-free, single-patient‑use, ophthalmic gel preparation indicated for administration under the direct supervision of a health care provider. Iheezo was approved based on three clinical trials. Trial 1 demonstrated 90% of patients administered Iheezo achieved successful anesthesia compared with 12% of patients who received placebo. The median time to achieving anesthesia with Iheezo was 0.67 minutes. The median duration of anesthesia was 14.3 minutes. Trial 2 demonstrated 95% of patients administered Iheezo achieved successful anesthesia compared with 20% of patients who received placebo. The median time to achieving anesthesia with Iheezo was 0.67 minutes. The median duration of anesthesia was 19.3 minutes. Trial 3 demonstrated Iheezo achieved sufficient anesthesia in 1 to 1.5 minutes in patients undergoing cataract surgery.2 Iheezo is supplied as a package of 1- or 10-units of 1.25mL single-patient-use vial(s) containing 24mg of chloroprocaine in 800mg of gel. Launch and pricing of Iheezo are pending.
Generic Drug Information
November 28, 2022
This quarterly pipeline wrap-up provides a review of newly approved specialty drugs, recent…
November 18, 2022
This quarterly pipeline wrap-up provides a review of newly approved traditional drugs, recent…
November 15, 2022
Mitchell Scott is Senior Director of Prime’s Special Investigations Unit (SIU) and Pharmacy…