Bausch + Lomb, Clearside Bag FDA Approval for XIPERE

Bausch Health Companies Inc.’s (BHC) global eye health business, Bausch + Lomb, along with Clearside Biomedical, Inc. (CLSD) announced to have bagged the U.S. Food and Drug Administration’s (FDA) approval for XIPERE, designed to treat macular edema associated with uveitis via suprachoroidal administration.

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Following the news, shares of the Bausch Health gained 2.7% in Monday’s early trading hours, while Clearside tanked 4.6%.

The approval is based on pivotal Phase 3 trial (PEACHTREE), a Phase 3, multi-center, non-interventional extension study (MAGNOLIA), and an open-label safety trial (AZALEA). (See Bausch Health stock charts on TipRanks)

The first study involved a randomized, multicenter, double-masked, sham-controlled Phase 3 clinical trial of 160 patients with macular edema associated with uveitis. The concerned treatment achieved at least a 15-letter improvement in BCVA than patients in the control arm at Week 24.

The companies expect to make XIPERE available by the first quarter of 2022.

Bausch Health’s chairman and CEO, Joseph C. Papa, said, “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 uveitis. The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication.”

Last month, Jefferies analyst David Steinberg assigned a Buy rating on Bausch Health with a price target of $37 (28.8% upside potential).

Consensus among analysts is a Moderate Buy based on 5 Buys and 1 Sell. The average Bausch Health price target stands at $35.50 and implies upside potential of 23.6% to current levels.

TipRanks data shows that financial blogger opinions are 100% Bullish on BHC, compared to a sector average of 72%.