Traditional Drug Pipeline Monthly Update: October 2022

Critical updates in an ever changing environment

October 21, 2022
This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

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

  • None

References

  1. https://www.pharmacytimes.com/view/fda-approves-omidenepag-isopropyl-for-elevated-intraocular-pressure-in-primary-open-angle-glaucoma-ocular-hypertension
  2. https://www.empr.com/home/news/iheezo-ophthalmic-gel-approved-for-ocular-surface-anesthesia/

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