Sun Pharma issued the following announcement on July 17.
Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceuticals Inc, USA, which is a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Ltd. (Sun Pharma), has launched XELPROS Xpress™ - an access program for patients prescribed XELPROS™ (latanoprost ophthalmic emulsion) 0.005%. XELPROS recently became commercially available in the U.S. for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in people with open-angle glaucoma or ocular hypertension. XELPROS is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost.
Through XELPROS Xpress, patients with a prescription can obtain XELPROS for a fixed price of $55 for a single month, or $37 per month for a 3-month supply. XELPROS was approved by the U.S. Food and Drug Administration (FDA) in September 2018.
“We created XELPROS Xpress to make it easier for patients to obtain XELPROS by offering direct access through pharmacies that distribute nationally and guarantee consistent cost plus high quality product and service,” said Mark Hagler, senior vice president and head of ophthalmics, oncology and long-term care at Sun Pharma. “XELPROS Xpress allows us to help patients at every step of the product ordering and fulfillment process, ensuring that they have the best possible experience.”
XELPROS Xpress is designed to facilitate access to XELPROS without prior authorization, step therapy, copay cards, or coupons. The program also provides prompt fulfillment services and refill reminders for patients.
XELPROS is contraindicated in patients with known hypersensitivity to latanoprost, or any other product ingredients. The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.
Eye care professionals and patients can obtain more information about XELPROS and XELPROS Xpress at Xelpros.com.
About XELPROS™
XELPROS™ (latanoprost ophthalmic emulsion) 0.005%, a translucent ophthalmic emulsion, is a topical formulation of latanoprost, a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. It is the first and only BAK-free form of latanoprost. The recommended dosage of XELPROS is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.
Across multiple XELPROS clinical trials, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), reported in 55% and 41% of patients treated with XELPROS, respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XELPROS is contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.
WARNINGS AND PRECAUTIONS
Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.
Eyelash Changes: XELPROS may gradually cause changes to eyelashes, vellus hair in the treated eye including increased length, thickness, pigmentation and number of lashes. The changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.
Macular Edema: XELPROS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.
Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
Use with Contact Lens: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.
ADVERSE REACTIONS
The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.
DRUG INTERACTIONS
Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart.
Please click here for Full Prescribing Information.
Disclaimer:
Statements in this “Document” describing Sun Pharma’s and SPARC’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.
About Sun Pharmaceutical Industries Inc., USA (SPII)
SPII is a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd, a Mumbai-based global specialty generic company that provides innovative, high-quality, affordable medicines trusted by customers and patients in more than 150 countries around the world. Sun Pharma's global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.
About Sun Ophthalmics
Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. In the U.S., Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% and XELPROS™ (latanoprost ophthalmic solution) 0.005% and will soon commence marketing CEQUA™ (cyclosporine ophthalmic solution) 0.09%. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.
Original source can be found here.
