Bausch Health Companies Inc and Clearside Biomedical Inc said on Monday they received approval from the U.S. health regulator for their eye injection, giving patients access to a novel treatment for vision loss resulting from an inflammatory eye condition.
The drug, Xipere, is injected to the back of the eye and delivers a version of a steroid commonly used for the treatment of uveitis, an inflammation of tissues in the eye.
Macular edema, a build-up of fluid in a part of the retina, is the leading cause of vision loss among people with uveitis.
Xipere achieved its main goal in Clearside’s late-stage study, with nearly half the patients on the treatment showing improvement in the clarity of their vision. The drug was also shown to be generally well tolerated.
With Xipere, high levels of medication can be delivered to target tissues, such as the retina and the drug can treat the swelling, leading to visual improvement, Dr. Steven Yeh, the main investigator for the study, told Reuters in an interview.
The drug delivery approach is the first of its kind for the treatment of macular edema stemming from noninfectious uveitis, which affects about 300,000 adults in the United States, Dr. Yeh said.
Other drugs used to treat the condition in the United States include Bristol Myers Squibb’s Kenalog, administered near the eye and AbbVie Inc’s Ozurdex eye implant. There are some topical treatments as well.
In 2019, Bausch acquired the rights to develop and sell Xipere in the United States and Canada from Clearside.
Bausch expects to make Xipere available in the United States during the first quarter of 2022.
“With this FDA approval, XIPERE™ is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis2. The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication,” said Joseph C. Papa, chairman and CEO, Bausch Health. “The approval of XIPERE™ exemplifies our commitment to bringing innovative new options to help patients improve their treatment journey. We expect to make XIPERE™ available during the first quarter of 2022.”
XIPERE™ Clinical Data
The clinical program for XIPERE™ included the pivotal Phase 3 trial (PEACHTREE), a Phase 3, multi-center, non-interventional extension study (MAGNOLIA), and an open-label safety trial (AZALEA).
The FDA approval of XIPERE™ was based on results from PEACHTREE, a randomized, multicenter, double-masked, sham-controlled Phase 3 clinical trial of 160 patients with macular edema associated with uveitis. XIPERE™ is the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a BCVA (Best Corrected Visual Acuity) primary endpoint.
The primary efficacy endpoint was the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with XIPERE™ (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, p< 0.01) at Week 247.
The most common adverse reactions reported by greater than or equal to 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.
Important Safety Information about XIPERE™ Indication
XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.
IMPORTANT SAFETY INFORMATION
Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.
- XIPERE is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- XIPERE™ is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.
- Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses, and should be used cautiously in patients with a history of ocular herpes simplex.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use.
- In controlled studies, the most common ocular adverse reactions were increased ocular pressure, non-acute (14%), eye pain, non-acute (12%), cataract (7%); increased intraocular pressure, acute (6%), cataract (7%), vitreous detachment (5%), injection site pain (4%) conjunctival hemorrhage (4%), visual acuity reduced (4%), dry eye (3%), eye pain, acute (3%), photophobia (3%), and vitreous floaters (3%), and in 2% of patients: uveitis, conjunctival hyperaemia, punctate keratitis, conjunctival oedema, meibomianitis, anterior capsule contraction, chalazion, eye irritation, eye pruritus, eyelid ptosis, photopsia, and vision blurred.
The most common non-ocular adverse event was headache (5%).
- Corticosteroids should be used during pregnancy or nursing only if the potential benefit justifies the potential risk to the fetus or nursing infant.
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.
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