- India-based Sun Pharma received approval from the Food and Drug Administration for Cequa, a dry eye treatment for increased tear production, the company announced in a Thursday statement.
- "Dry eye is a complex disease that lacks a 'one-size-fits-all' approach," Jodi Luchs, principal investigator for a Phase 3 study of the drug, said in a statement. "As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal."
- An ophthalmics division of Sun's U.S. subsidiary will commercialize the drug. On foreign markets, Sun shares were up roughly 3% after news of the approval.
Sun has enjoyed a relatively positive year. The company got its first thumbs up for a biologic in March with Ilumya (tildrakizumab), and solved some long-standing manufacturing issues with the FDA concerning a key Halol plant in June.
But there have been setbacks as well. Ilumya is attempting to gain share in a competitive market, and Sun voluntarily recalled some hydrochloride tablets after discovering a piece of rubber glove in one metformin hydrochloride tablet.
While the approval of Cequa (cyclosporine ophthalmic solution) 0.09% falls into the positive news category, it also pits Sun against another recently approved dry eye drug, Shire's Xiidra (lifitegrast).
Dry eye is an ophthalmic area with high unmet medical need. Shire, which recently agreed to a takeover bid from Japan's Takeda Pharmaceutical, shifted to developing eye treatments around 2013 and is now beginning to see the success of that move, as the Xiidra brand continues to see strong growth.
"Ophthalmics product sales increased 75% and 69% to $100.3 million and $162.4 million during the three and six months ended June 30, 2018, respectively, due to Xiidra demand growth," the Irish pharma said in its most recent quarterly filing with the Securities and Exchange Commission.
More drugs are coming to treat dry eye as well. Aurinia Pharmaceuticals is expected to report top line Phase 2 data for its dry eye drug, voclosporin, in late-2018 or early-2019.
Eye drugs encounter daunting scientific complexity in getting to market, making ophthalmology one of the tougher spaces to break into — or drive considerable growth. For example, Novartis announced in late-June it will spin off Alcon, its eye care device business, in the first half of 2019 as it narrows in on oncology.
But the high patient demand for an array of eye diseases makes the area attractive and potentially lucrative. Analysts anticipate extensive growth in the global eye market, with age-related macular degeneration drugs leading the profitability path.