UPDATE: Aug. 28, 2019: Staar Surgical Tuesday said FDA authorized initiation of a U.S. human clinical study of its EVO/EVO+ Visian implantable collamer lenses for myopia and myopia with astigmatism, per an Aug. 23 letter from the agency.

"FDA also recommended study design modifications, which Staar plans to incorporate into the investigational plan in a revised submission in the coming month," the company wrote in the update. Analysts at William Blair project a mid-2021 U.S. approval for the device, if FDA and Staar come to a final agreement on study design, they wrote in a note to investors Tuesday.

"In our view, this morning’s announcement should act to remove the overhang caused by uncertainty with the FDA, but is probably a net negative for any revenue growth assumptions bulls had for these products in the intermediate term and forces growth in international markets (especially China) to sustain itself for a longer period," the analysts said.

Dive Brief:

• Staar Surgical on Friday disclosed that FDA has advised the company its premarket approval application supplement for a pair of second-generation implantable lenses to treat myopia lacks the clinical evidence and analysis necessary to complete a review of safety and effectiveness.
• In a regulatory filing, the company said it expects to continue discussions with FDA on its concerns about the PMA for the EVO/EVO+ Visian implantable collamer lenses for myopia and myopia with astigmatism and any new clinical data that may be required.
• The company’s shares sank to their lowest level in a year on the news, closing down more than 11% at $25 on Nasdaq.

Dive Insight:

The setback for Staar Surgical’s second-generation lenses caught many investors by surprise. William Blair analyst Brian Weinstein said in a note to clients Wall Street was expecting the devices to gain FDA approval in late 2019 or early 2020, even with a lack of long-term data, and provide a boost to the company’s revenue. The lenses are approved in countries around the world but not in the United States, he said.

Staar Surgical’s line of implantable lens are intended to eliminate or lessen dependence on glasses or contact lenses. The devices are foldable to allow the surgeon to insert them through a small incision, in a procedure that lasts 20 to 30 minutes.

Last month, the company marked a milestone with the announcement that one million of its Visian lenses have been implanted in patients globally. Staar introduced its first implantable collamer lens for myopia in 1997. The Visian line includes lenses to correct a range of vision problems, including myopia, hyperopia and astigmatism.

FDA’s May 2 letter to the company comes a day after Staar reported a 20% rise in first quarter sales, to $32.6 million, from the year before. Driving the increase was a 31% boost in sales of its implantable lenses in the quarter, which ended on March 29.

The company did not comment on what deficiencies in the clinical evidence and analysis FDA found.

Staar had previously indicated that FDA would require a U.S. clinical trial if the agency did not accept the company’s initial data, the analyst said. The company predicted that process would take six months to a year.

“We think a silver lining here is that this update came in the first half of the year rather than later on, as it will give the company ability to reset its approval efforts and hopefully gather the data to submit something again early next year, which could still lead to approval in late 2020,” Weinstein wrote.