Sparc is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. Sparc has extensive drug development experience in areas of new chemical entities and novel drug delivery systems. Its delivery platform technologies are clinically validated with products approved in several markets.
Latanoprost Eye Drops, as a prostaglandin medicine (one of the first-line treatments for open-angle glaucoma or ocular hypertension), is developed with LipixelleTM technology that dissolves latanoprost with non-ionic surfactants, and can achieve BAK-free delivery to avoid the potential ocular damage caused by long-term use of BAK. The product has been approved for marketing in the U.S.
The prevalence of primary open-angle glaucoma with ocular hypertension in China is estimated to be 1.5% to 2%, with more than 20 million people. Latanoprost Eye Drops is expected to be a safe and effective treatment option for patients suffering from relevant diseases.
Levetiracetam XR Tablet, developed based on the WrapMatrixTM technology of the Group’s partner SPARC, is a novel extended-release tablet designed to have higher doses of levetiracetam (1000mg/1500mg). The product has been approved for marketing in the U.S.
With higher doses, Levetiracetam XR Tablet is expected to reduce pill burden and improve patient compliance.
SDN-37 is a novel long-acting (twice-a-day) steroid ophthalmic formulation approved by the U.S. FDA. Currently marketed steroidal eye drops require administration every 4 to 6 hours, but SDN-037 is administered only twice a day, which improves the dosing convenience. Meanwhile, the formulation of SDN-037 is clear, compared to marketed formulation which is milky and resulting in blurring of vision after administration.
In October 2020, the Group’s partner SPARC announced that the U.S. pivotal phase III clinical trial of SDN-37 had achieved positive top-line results, which met the primary and secondary objectives and SDN-037 was generally well tolerated in the study.
According to statistics, in China, ophthalmic surgery discharged 4.7 million patients in 2016, and the total cases of cataract surgery were 2.3 million, and refractive surgery 1 million. As there is currently no preparation of the reference steroid in Mainland China, the product is expected to provide a novel treatment option for patients.
PDP-716 is a novel brimonidine formulation developed by the Group’s partner SPARC’s proprietary resin microparticle-complexed drug technology, TearActTM, which provides controlled and consistent delivery of the medicine to improve drug bioavailability and drug exposure, enabling once daily administration.
In May 2021, SPARC announced positive top-line results from the pivotal phase III clinical trial of PDP-716 Eye Drops in the U.S. The trial met its pre-specified primary endpoint, demonstrating that PDP-716 Eye Drops dosed once daily is equivalent to Alphagan® P 0.1% dosed three times daily, which is also the brimonidine formulation; in terms of safety, treatment emergent adverse events of the two products were similar.
In China, the prevalence of open-angle glaucoma is approximately 2%, with most patients aged between 20 and 60 years old, and only 1 in 6 of the patients have normal intraocular pressure. Compared with the marketed brimonidine formulations dosed three times daily, the product provides patients with greater treatment convenience.
