Allergan Reports FDA’s Acceptance of NDA for Bimatoprost Sustained-Release to Treat Glaucoma or Ocular Hypertension

Allergan Reports FDA’s Acceptance of NDA for Bimatoprost Sustained-Release to Treat Glaucoma or Ocular Hypertension

Shots:

  • The NDA submission is based on P-III ARTEMIS studies results assessing Bimatoprost SR vs timolol in 1122 patients with open-angle glaucoma or ocular hypertension for 12wks.
  • The P-III ARTEMIS studies results demonstrated 30% reduction in intraocular pressure (IOP) and more than 80% remained treatment free with no maintenance treatment for at least 12 mos. following 3 treatments with Bimatoprost SR and is well tolerated
  •  Bimatoprost (marketed as Lumigan 0.01%) available as an eyedrop indicated to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Click here to read full press release/ article | Ref: Allergan | Image: Market watch