Sun Ophthalmics to Present Updated CEQUA™ and XELPROS™ Data at AAOPT/WCO 2019

“Our slate of presentations and booth presence at the joint AAOPT/WCO conference signals an expanding presence for Sun Pharma in the ophthalmics field, underscoring our commitment to patients with ocular diseases and the physicians who treat them,” stated Dr. Nicholas Squiterri, Director, Medical Affairs, Sun Pharmaceuticals Industries Inc. “In addition to the CEQUA and XELPROS data updates, our presentations will include survey data that shed light on patient and physician needs in the treatment of dry eye disease, and we look forward to engaging with conference attendees to help them understand the implications of these data.”

Details on the poster presentations at AAOPT/WCO are as follows (all posters will be presented in Exhibit Hall WO1 of the Orange County Convention Center):

CEQUA

• Thursday, October 24, 4:30-6:30pm: Karpecki P, et al. Effect of OTX-101, a novel nanomicellar cyclosporine A formulation, on conjunctival staining in individual zones in patients with keratoconjunctivitis sicca. Poster #3.
• Thursday, October 24, 4:30-6:30pm: Kabat A, et al. Effect of OTX-101, a novel nanomicellar cyclosporine formulation, on corneal staining over a 3-month treatment period: Results from a pooled analysis. Poster #4.
• Thursday, October 24, 4:30-6:30pm: Shen Lee B, et al. Effect of OTX-101, a novel nanomicellar cyclosporine A formulation, on tear production in patients with aqueous deficient keratoconjunctivitis sicca. Poster #5.

Dry Eye Patient and Physician Survey Presentations

• Friday, October 25, 10:00am-12:00pm: White DE, et al. Physician satisfaction with anti-inflammatory topical medications for the treatment of dry eye disease. Poster #96.
• Friday, October 25, 1:00-3:00pm: White DE, et al. Treatment satisfaction among patients using anti-inflammatory topical medications for dry eye disease. Poster #95.

XELPROS Presentations

• Thursday, October 24, 4:30-6:30pm: Shen Lee B, et al. Long-term safety evaluation of latanoprost 0.005% without benzalkonium chloride in patients with open-angle glaucoma or ocular hypertension. Poster #164.
• Thursday, October 24, 4:30-6:30pm: Kabat A, et al. Efficacy and safety of latanoprost 0.005% without benzalkonium chloride vs latanoprost 0.005% with benzalkonium chloride administrated daily in patients with open angle glaucoma or ocular hypertension. Poster #166.

AAOPT/WCO attendees are invited to visit Sun Ophthalmics at Booth #1409 in Exhibit Hall WO1.

About CEQUA

CEQUA (cyclosporine ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges and penetrate the eye’s aqueous layer, whilst preventing the release of the active lipophilic molecule prior to penetration. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.

In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study, 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.01). Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle, with some showing improvement as early as 1 month following treatment. Adverse events reported in the trial were mostly mild in nature. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated increased tear production (p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis urinary tract infection, headache, and bronchitis.

CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use is commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.

INDICATIONS AND USAGE
CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

ADVERSE REACTIONS
The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please click for Full Prescribing Information and for more information visit CEQUA.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 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 addition to CEQUA™ (cyclosporine ophthalmic solution) 0.09%, Sun Ophthalmics markets BromSite^® (bromfenac ophthalmic solution) 0.075% and Xelpros™ (latanoprost ophthalmic solution) 0.005% in the U.S. 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.

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