When it comes to the stock market, Bausch Health’s has been rising steadily, up 4.1% in the past month, and on November 13 hit a 52-week high; Zacks Equity Research thinks the recent run may continue, and with good reason as the company just partnered with Clearside Biomedical to enter into the suprachoroidal space with a product designed to treat macular edema associated with uveitis. There are currently no treatments for this disease in the U.S. According to Clearside, roughly 30 diseases that cause inflammation in the eye fall under the uveitis classification, and about 350,000 people in the U.S. have uveitis, most of whom are between 20 and 50 years old. Between 30% and 40% of those with uveitis also have macular edema.
XIPERE (formerly known as CLS-TA) is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via suprachoroidal injection. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space, enabling rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye.
Getting XIPERE to market
Whether or not Wall Street will continue to embrace the deal may depend on the successful commercialization of XIPERE, which Clearside decided to out-license rather than develop internally. Clearside had expected to resubmit its New Drug Application for the product to the U.S. FDA for review in the first quarter of 2020, but has recently been informed that the FDA made an additional request of its commercial contract manufacturer, which Clearside believes will delay the NDA submission until the second quarter of 2020. The initial submission garnered a Complete Response Letter from the FDA as the Office of Pharmaceutical Quality (OPQ) requested stability data for the triamcinolone suspension produced using an enhanced manufacturing process. The OPQ wanted the data to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process with that of the batches originally submitted as part of the NDA. Clearside had earlier reported the requested data does not relate to or affect the SCS Microinjector.
(Of note, Clearside also inked deals for its SCS Microinjector with RegenXBio for use in gene therapy and Aura Biosciences for the potential treatment of certain ocular cancers, including choroidal melanoma.)
If it’s approved, XIPERE will join Bausch+Lomb’s retina portfolio, which currently includes Macugen, Visudyne and Retisert on the pharmaceutical side, the Stellaris Elite vision enhancement system, Pinnacle 360, illuminated directional probes, and Bi-Blade dual port vitrectomy cutters on the surgical side, and PreserVision AREDS 2 vitamins, available over-the-counter.
Joseph C. Papa, chairman and CEO of Bausch Health, said, “Bausch Health is committed to … augmenting our pipeline with investigational treatments like XIPERE, which we believe will complement our Bausch+ Lomb portfolio of integrated eye health products.”
Bausch and Clearside licensing deal
When the initial deal was announced on October 23, Bausch stock closed at $22.56. Whether news of the Clearside deal had much effect or not on overall value, the company’s stock has continued to rise and as of November 13 closed at $27.38. Wall Street seemed to like the deal for Clearside, with Seeking Alpha reporting a 21% increase premarket in their stock on 10/23, which it attributed to the deal. Clearside’s stock rose from $0.79 on October 22 to $0.94 at the close of the next day. It rose to a high of $1.29 on November 4, and has cooled off to $1.06 on November 13.
In its quarterly statement, Clearside noted the deals with Bausch Health, RegenXBio, and Aura “will benefit Clearside in a number of ways: 1) we have eliminated the inherent risks and investment related to building and maintaining a commercial infrastructure for XIPERE ourselves; 2) we are entitled to receive $7 million of non-dilutive capital in upfront payments and are eligible to receive over $200 million in potential future development and sales milestones and royalty payments; and 3) we have expanded the use of our platform to other indications including choroidal melanoma, wet age-related macular degeneration, and diabetic retinopathy,” Clearside CEO George Lasezkay, PharmD, JD, said.
Bausch Health also has the right to pursue development and commercialization of XIPERE for additional ophthalmic indications in the U.S and Canada, and has the right to develop and commercialize the SCS Microinjector in combination with certain specified corticosteroids and nonsteroidal anti-inflammatory drugs within the ophthalmic marketplace.